It was reported that, during a procedure, the upper jaw of the first-pass suture passer fell off, after pulling the trigger once and without chewing anything, backup device was available to complete the procedure.No delay and no patient injuries were reported.
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Internal complaint reference: (b)(4).The reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection of the returned instrument shows no manufacturing abnormalities.No visual issues were observed.The upper jaw and suture capture are still attached to device.A functional evaluation revealed the needle will deploy when trigger is initiated.The sutures are able to pass, the upper jaw is loose.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.
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