MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT OBURATOR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL

Catalog Number TVTOBTUNK

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Nonresorbable materials, unretrieved in body (2276)

Event Date 08/29/2014

Event Type  Injury  

Event Description

It was reported that a patient underwent a gynecological procedure on (b)(6) 2014 and an obturator sling was implanted.The physician stated that after insertion, a piece of plastic that was attached to the mesh remained in the patient.The mesh was removed and a new mesh inserted via a different dissection path.The sheath was not found.No additional information was provided.

Manufacturer Narrative

(b)(4).Conclusion: user error caused the event.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

• Brand Name: GYNECARE TVT OBURATOR SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20 2000 neuchatel; neuchatel ; SZ
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4098295
• MDR Text Key: 4761585
• Report Number: 2210968-2014-13094
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TVTOBTUNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention