MAUDE Adverse Event Report: LINVATEC CORPORATION D/B/A CONMED LINVATEC SUTURE RETRIEVER; ACCESSORIES,ARTHROSCOPIC

Model Number 9892

Device Problems Sticking (1597); Failure to Fire (2610); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2017

Event Type  malfunction  

Event Description

Information from our defective product return form, "when it fires, then retracts, it feels like it gets caught on the lip and makes the wiring inside scrunch up making it impossible to re-fire".Patient was not harmed.More units were opened and all had the same failure.

• Brand Name: SUTURE RETRIEVER
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): LINVATEC CORPORATION D/B/A CONMED LINVATEC; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 6544111
• MDR Text Key: 74439341
• Report Number: 6544111
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/14/2021
• Device Model Number: 9892
• Device Catalogue Number: 9892
• Device Lot Number: 800382
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2017
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1