This supplemental report is being submitted to provide additional information.The exact cause of the reported event could not be conclusively determined, however there is possibility that the reported event was caused by the following; fatigue fracture of metal due to repeated use of the device.The forceps was raised with excessive force using an endotherapy accessory that was not applicable.With the forceps raised, an excessive force was applied to insert and remove the endotherapy accessory.At this user facility, complaint of the same event and the same device occurred in the past.The instruction manual provides preventive measures against the reported failure mode.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.
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