Visual inspection: the complaint device depth gauge for lckng scrs to 100 (product code: 03.010.072, lot number: l654370) was returned to cq (b)(4) for investigation.No other issues were identified during visual inspection.Device/defect identified: no.Document /specification review: based on the date of manufacture, the current and manufactured version of the drawings were reviewed.Complaint confirmed: complaint cannot be confirmed based on the available information.Conclusion: there were no issues with the depth gauge and the slider slid over the body without any issues.Hence, the complaint was not confirmed.A definitive root cause cannot be determined from the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Part: 03.010.072.Lot: l654370.Manufacturing site: (b)(4).Supplier: n/a.Release to warehouse date: 22 february 2018.Expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|