MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT OBTURATOR W LASR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 810081L

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Summary: received for evaluation one device, assembly mesh with one white needle.The device received was manipulated.The mesh is cut, one plastic needle is missing and organic substances are visible on the guides.The defect seen during the product evaluation is aligned with the defect described in the event description (damaged mesh).The manufacturing process could not create this defect.The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.

Event Description

It was reported that the patient underwent an unknown procedure on unknown date and the mesh was used.During the procedure, the surgeon could not use the mesh as it was defective.During evaluation, the received mesh was found torn/cut.

Manufacturer Narrative

Date sent to the fda: 12/14/2018.Additional narrative: during a surgery that took place on (b)(6) 2018 at the hospital (b)(6).It was reported that once the surgeon pulled the mesh through the left inguinal side, it was observed that the mesh broke at the central part, the bladder is stitched.No additional information was provided.

• Brand Name: GYNECARE TVT OBTURATOR W LASR
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8162043
• MDR Text Key: 130329781
• Report Number: 2210968-2018-77744
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• Combination Product (y/n): N
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 810081L
• Device Lot Number: 3931861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Date Manufacturer Received: 11/15/2018
• Patient Sequence Number: 1