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

Model Number 810081

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts are being made to retrieve the device.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

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 white cover of the trocar was not adhered to, so the trocar could not be inserted properly.There were no adverse patient consequences reported.No further information was disclosed.

Manufacturer Narrative

(b)(4).Date sent to fda: 02/02/2021.Photo analysis summary: a picture was received for evaluation.Upon visual inspection of the image, the white cover of the trocar was partially inserted of product code 810081, lot 3937205 could be observed.No conclusion could be reached as on what caused the reported complaint, since the sample was not returned for analysis.The manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.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: 3/5/2021.  h3 evaluation: the device was received and evaluated by the manufacturer.The received device was manipulated as there was no packaging (no lid nor blister).A part of the box was sent with batch number and bar codes.The helical passers were inserted in the white plastic needles correctly.The tip of one needle was twisted and damaged.The mesh was still assembled to the needles.The winged guide was also present.The defect on device seen during the product evaluation is aligned with the defect described in the event description.The identified defect is not linked to a manufacturing issue.Events of this type are trended regularly, therefore this complaint is being closed to trending.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: 11081631
• MDR Text Key: 224394097
• Report Number: 2210968-2020-10331
• 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,Followup
• Report Date: 12/07/2020

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: 06/30/2021
• Device Model Number: 810081
• Device Catalogue Number: 810081
• Device Lot Number: 3937205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/22/2021; 02/05/2021
• Supplement Dates FDA Received: 02/02/2021; 03/07/2021
• Removal/Correction Number: N/A
• Patient Sequence Number: 1