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

Model Number TVTOML

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 a gynecological procedure on (b)(6) 2020 and mesh was used.It was reported that the sling was found with defect when the package was opened, which made it impossible to be used.The procedure was completed using a like device with no adverse patient consequences.No additional information was provided.

Manufacturer Narrative

(b)(4).Date sent to fda: 10/27/2020 corrected information: d1, d4, g5, h4 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.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 10/29/2020 additional information: d10, h6 h3 evaluation: the received device was manipulated.The implant was returned without the blister and lid.It was observed that the device was not in its original state because the helical passers, plastics needles and mesh were present but totally disassembled.Additionally, the mesh was cut and the white plastic needles were dirty.The plastic sheath was damaged with cracks.The mesh was damaged at different points and the three lines were not continuous all along the mesh.The defect on device seen during the product evaluation is aligned with the defect described in the event description ("crashes on device").The defect identified is not linked to a manufacturing issue.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria for lot 3935193 and product code 810081.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, 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: 10553721
• MDR Text Key: 207541300
• Report Number: 2210968-2020-07077
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062368
• UDI-Public: 10705031062368
• Combination Product (y/n): N
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2020

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: 08/31/2020
• Device Model Number: TVTOML
• Device Catalogue Number: 810081
• Device Lot Number: 3935193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Initial Date Manufacturer Received: 08/28/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 10/27/2020; 10/02/2020
• Supplement Dates FDA Received: 10/27/2020; 10/29/2020
• Patient Sequence Number: 1