The customer reported that the aes-1 was being used on 20dec23 during a shoulder arthroscopy and ¿the situation is that when they were using the aes-1 the saline solution became very hot and burned the cutaneous area around the arthroscopic portal, as the liquid came out.The hospital does not know which of its devices were used, so we removed all devices.We also did an internal test and the results were these: sn:(b)(6): connector damaged, it does not detect bipolar terminals.¿.Per further assessment the degree of burn is unknown and there was no medical/surgical intervention or prolonged hospitalization required for the patient/user.The procedure was completed without an alternate device.This report is being raised due to the reported injury of burn where the degree of burn is unknown.
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The customer reported that the aes-1 was being used on (b)(6) 2023 during a shoulder arthroscopy and ¿the situation is that when they were using the aes-1 the saline solution became very hot and burned the cutaneous area around the arthroscopic portal, as the liquid came out.The hospital does not know which of its devices were used, so we removed all devices.We also did an internal test and the results were these: sn:(b)(6): connector damaged, it does not detect bipolar terminals.¿.Per further assessment the degree of burn is unknown and there was no medical/surgical intervention or prolonged hospitalization required for the patient/user.The procedure was completed without an alternate device.This report is being raised due to the reported injury of burn where the degree of burn is unknown.
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Reported event of ¿saline solution became very hot and burned the cutaneous area¿ was confirmed.The internal test found that the connector pin was damaged, and it does not detect bipolar terminals.The preventative maintenance (pm) was overdue.The preventative maintenance (pm) was completed on this repair order.The final test was completed and met all specifications.A root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be that the device was not serviced at the 12-month interval recommended in the instruction manual.The service history was reviewed and no relationship to this complaint was found.A device history record review was not conducted as the device has been in the field greater than 12 months.A two-year review of complaint history revealed there has been a total of 4 reports, regarding 4 devices, for this device family and failure mode.During this same time frame 663 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.006.Per the instructions for use, the user is advised the following: the proper use and placement of a dispersive electrode is a key element in the safe and effective use of electrosurgery in monopolar procedures, particularly in the prevention of burns.Follow manufacturer¿s directions and recommended practices for the preparation, placement, use, surveillance, and removal of any return electrode supplied for use with this electrosurgical unit.The aes-1 generator shall be returned to conmed customer service department (refer to ¿5.1 assistance and repair¿) every 12 months for servicing.We will continue to monitor for trends through the complaint system to assure patient safety.
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