Additional narrative: part #: 03.168.013; lot #: 170413-205; supplier lot #: 170413-205; release to warehouse date: may 25, 2018; supplier: (b)(4); no ncr's generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the protection sleeve for fns insertion instruments (part # 03.168.013 / lot # 170413-205) was received at us customer quality (cq).Upon visual inspection, the distal tip of the device was found to be deformed/bent outward.Additionally, there were scratches on the device which do not affect the functionality of the device.No other defects were observed with the returned device.Device failure/defect identified? yes.Dimensional inspection: specified dimensions: distal tip od.Measured dimensions: distal tip od (before bend) = conforming device used - caliper.Document/specification review: the following current and manufactured revisions were reviewed: manufactured and current revisions.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the distal tip of the device was deformed outward.No definitive root-cause can be determined based on 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.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.
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