MAUDE Adverse Event Report: ETHICON, INC. GYNECARE TVT; MESHSLING, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS U

Model Number 810081L

Device Problem Material Puncture/Hole (1504)

Patient Problem No Information (3190)

Event Date 09/17/2014

Event Type  malfunction  

Event Description

When surgeon attempted to load the helical introducer into the plastic sheath attached to the mesh implant, the introducer punctured through the sheath.

• Brand Name: GYNECARE TVT
• Type of Device: MESHSLING, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS U
• Manufacturer (Section D): ETHICON, INC.; route 22 west; p.o. box 151; somerville NJ 08876
• MDR Report Key: 4647659
• MDR Text Key: 5755024
• Report Number: 4647659
• Device Sequence Number: 1
• Product Code: OTN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 810081L
• Device Catalogue Number: 810081L
• Device Lot Number: 3744205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR