Type: Laparoscope, general and plastic surgery
Manufacturer: Karl Storz SE & Co. KG
Brand: Clickline
Model: 33300
Cat: 33300
Event Description: I would like to inform you about the quality of new instrumentation we have been receiving from Karl Storz this last month. These items were brand new out of the box with multiple lot numbers being affected. Images were obtained via borescope. We currently inspect all devices that come into our facility and the findings are far from quality. The manufacturer is providing our facilities with "rusted" 5mm Karl Storz laparoscope tubes and this may lead to significant patient harm.
Photo: Interior of new laparoscopic instrument.
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Type: Interventional fluoroscopic x-ray system
Manufacturer: Siemens Healthcare GmbH
Brand: Artis zee multipurpose
DI-UDI: 04056869010076
Model: 10094139
Cat: 10094139
Event Description: A catastrophic failure of a floor mounted C-arm radiography unit occurred. The C-arm fell from the vertical extremity of the arm support while being prepared for a patient exam (patient was in the doorway). No patient or staff were harmed, however, it was a very close call. The system that failed was installed approximately two years ago. Upon falling to the floor, a worm gear (vertical threaded guide rod) that the C-arm moves on was visibly broken into multiple pieces. The detector cut off from the force of impact. The technician operating the C-arm heard a loud bang prior to the unit crashing to the floor. This C-arm was stored in the vertical position for approximately one month without use. Preventative maintenance was completed by the manufacturer the week prior to the event. This storage procedure is acceptable per the manufacturer instructions for use. Prior to this incident, a similar case was successfully completed on the same equipment.
Type: Catheter, intravascular, therapeutic, long-term greater than 30 days
Manufacturer: Bard Access Systems, Inc.
Brand: PowerHickman
DI-UDI: 00801741036675
Model: 0805815
Lot: REHY0721
Cat: 0805815
Event Description: The physician noticed a defective Hickman catheter with the Surecuff on the PowerHickman single lumen device. While the catheter was being placed, the physician noticed the cuff was sliding along the catheter, meaning it was not fixed. The device is intended to have a cuff fixed on a specific area of the catheter. The cuff is located near the opening in the skin and is designed to grow into the skin over time. The physician replaced the product with a new PowerHickman single lumen catheter that had a secured cuff.
Type: Transcatheter septal occluder
Manufacturer: W. L. Gore & Associates, Inc.
Brand: Gore Cardioform
UDI-DI: 00733132631032
Model: GSX0030A (x2)
Cat: GSX0030A (x2)
Event Description: A Gore Cardioform septal occluder was used to close a patent foramen ovale (PFO) in the cardiac catheterization lab. The septal occluder folded when it was deployed and as a result the patient suffered a cut (laceration) of the back left atrium. A second device was inserted, and the same thing happened. The second attempt to close the PFO with the second device resulted in a laceration to the left atrial appendage. The patient was converted to an open procedure (sternotomy) in the cardiac catheterization lab. The sternotomy and exploration stabilized the patient after repair of the lacerations and closure of the PFO. The patient recovered in the ICU.
Type: Dialyzer, high permeability with or without sealed dialysate
Manufacturer: Outset Medical, Inc.
Brand: Tablo Hemodialysis System
DI-UDI: 00850001011204
Model: PN-0006000
Event Description: Smoke and flames were seen coming from a dialysis machine while it was in storage and not in use. It was quickly unplugged and disconnected from the wall, as well as placed in a safe location. The device was sent to the manufacturer for evaluation, who reported "following an extensive examination of the console, it became [clear] that a leak had occurred inside the unit. This leak [caused] a short circuit [resulting in] damage to a board within the system. In response, we are taking necessary steps to address the situation. Specifically, we are in the process of ordering new cables and boards to replace those that were impacted by the leak. This proactive approach ensures that we will be able to swiftly repair and restore the console to full functionality in the shortest possible time.”
Type: Pump, infusion, PCA
Manufacturer: Smiths Medical ASD, Inc.
Brand: CADD
DI-UDI: 15019517154290
Model: 2110
Lot: 2022-05-01
Cat: 21-21110402-51
Event Description: Approximately two years ago, we replaced our fleet of 160 patient-controlled analgesia (PCA) pumps with new Smiths Medical CADD SOLIS 2110 PCA pumps. Within one month of deployment, 16 devices had a wireless communication loss error that stopped the pump from working. We removed the 16 and communicated with the manufacturer for a resolution under warranty. After a few months they had us send in three pumps for evaluation of the issue. After nearly one year, we received the three pumps back. Their documentation states they confirmed the issue, performed preventative maintenance of the device, and recommend that we replace the wireless card on the device, since they do not support or repair the wireless portion of their own device. The most likely cause of the failure is a bad communication module. We are now in a position of having a fleet of PCA pumps with an expired warranty and a vendor that will not repair or support their own device. In summary, we have medical devices that have a wireless failure that stops treatment, and the vendor will not provide the needed repair or a workable cause or solution.
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