Investigation results: visual investigation: distal end of sliding sheet is damaged.Co2 cartridge is empty.Vigilance investigator carried out the pictorial documentation visually and microscopically.Distal end of sliding sheet is deformed, no clips remained in the cartridge.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 3(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a product safety case (psc) was initiated.Any action regarding capa will be addressed with this case.
|