It was reported that during a knee arthroscopy procedure, the distal end of the lens was found cracked outside the patient.Backup device was available to complete the procedure.No delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
|
The device, which was used in a procedure, was returned for evaluation.There was a relationship between the reported event and the device.A visual inspection was performed and showed the scope to have distal tip and fiber damage, a dented outertube and distal lens damage.This failure is confirmed not originate from manufacturing, packaging, or labeling defects.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.No manufacturing related defects were observed.
|