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

Model Number 810081

Device Problem Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: how the procedure was completed? the procedure was completed without any problem.Did the removal of the device happened in the same procedure ? yes, same procedure.Was there any patient consequences? didn¿t have any feedback about the patient¿s problem.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.To date, the device has not been returned.If the device, or further details are received at a later date, a supplemental medwatch will be sent.

Event Description

It was reported that a patient underwent an urological procedure on (b)(6) 2020, and mesh was used.It was reported that the mesh tension was found to be weak, and therefore the mesh was removed during the same procedure.The procedure was completed successfully, and there were no adverse patient consequences reported.

Manufacturer Narrative

(b)(4).Date sent to fda: 12/29/2020.H3 analysis summary: the device received was manipulated.The implant was returned with the lid but without any other packaging part, needles or helical passers.Some organic material was visible on both mesh parts.One part of the mesh has been stretched.Second part of the mesh was in good conditions (presence of organic material), the edges were not damaged and the three continuous lines were visible.The reported event was not observed during the product evaluation.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: GYNECARE TVT OBTURATOR
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10824133
• MDR Text Key: 215945023
• Report Number: 2210968-2020-08962
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: 10705031000346
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

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: 03/31/2021
• Device Model Number: 810081
• Device Catalogue Number: 810081
• Device Lot Number: 3936483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 12/14/2020
• Supplement Dates FDA Received: 12/29/2020
• Removal/Correction Number: N/A
• Patient Sequence Number: 1