Visual investigation: collective report - here we found deformed latches/tips of the slider sheet and clip jams.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: there are no hints of a pre-damage or similar.Investigations leads to the assumption that the titanium clip cartridge was engaged not completely or was damaged during inserting.If the cartridge is engaged not completely or was damaged during inserting, there is an impairment of product functionality.This could lead to deformations on the slider sheet, to clip jam and can cause the titanium clip cartridge to jump off.Possibly a damaged clip applicator due to a deformed push rod or something similar could be another cause for a detached titanium clip cartridge.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 corrective action and preventive action (capa) has been initiated.
|