MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® SUTURE PASSER; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 1GSP02

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to gore that during a hernia repair procedure on (b)(6) 2018 using a suture passer instrument, the needle tip broke off in the patient.It was reported they were able to retrieve all pieces.It was reported that no further intervention was needed and there was no harm to the patient.

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.The engineering evaluation stated there has been no evidence revealed by this investigation that would lead this investigator to believe that the suture passer failed to meet its performance specifications or that the device did not perform as intended.The device was designed to be used in the undamaged condition as indicated in the ifu: ¿do not bend the needle or sleeve assembly.If the needle/sleeve is bent or damaged, replace with new assembly¿.

• Brand Name: GORE® SUTURE PASSER
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7550248
• MDR Text Key: 109624585
• Report Number: 3003910212-2018-00031
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K935986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2019
• Device Catalogue Number: 1GSP02
• Device Lot Number: 06563817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR