An evaluation of the returned device found that the body is damaged (cracked at head back, failed leak test and hipot, the grabber is cracked at insert, the focus ring is discolored also failed high frequency test.The service history was reviewed and no relationship to this complaint was found.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment.A two-year review of complaint history revealed there has been 1 complaint regarding 1 device for this device family and failure mode.During the same time frame 2,341 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be.0004 per the instructions for use, the user is advised the following; if the video image is not present or is interrupted, ensure proper connection of camera head cable to the camera controller.If the problem persists do not proceed, return the product for service/repair.A determination for further investigation has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.
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The conmed representative reported on behalf of the facility that the im8120, true hd camera head, during a gallbladder procedure on (b)(6) 2019 went dark due to interference with the valley lab and covidien units.The loss of vision caused the patients' blood vessel to be cut.The patient was taken post procedure to the emergency room.There is no further information on the patient status.This report is being raised due to patient injury.
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