MAUDE Adverse Event Report: ARTHROCARE CORP. DISPOSABLE FIRSTPASS SUTURE PASSER, SELF

Catalog Number 22-4038

Device Problems Material Integrity Problem (2978); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2020

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, when the first pass was used, the jaw could not be opened.Backup device was available to complete the procedure.No delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3,h6: the device, used in treatment, was returned for evaluation.A relationship between the device and reported incident was not established.A review of manufacturing records for the reported lot number found no non-conformances or anomalies during manufacturing process related to the reported event.Visual inspection shows no manufacturing abnormalities on the device.The instrument was returned with a closed top bracket; the suture capture is in its original condition.During functional evaluation the first step of the trigger could be easily released and engaged as intended.Fully pressing the lever the needle was extracted as intended.Potential factors unrelated to the design or manufacture of the device that may lead to the failure reported include, but are not limited to: (1) excessive force (2) tissue thickness.

• Brand Name: DISPOSABLE FIRSTPASS SUTURE PASSER, SELF
• Type of Device: PASSER
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10230791
• MDR Text Key: 197784302
• Report Number: 3006524618-2020-00440
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00885556724545
• UDI-Public: 885556724545
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22-4038
• Device Lot Number: 2032206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2020
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1