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

Model Number 810081

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Can you please clarify what is meant by "the plastic cannot be pulled out"? is this event related to the clear plastic sheath over the mesh or the white plastic sheath for the helical passers? was any part of the "plastic" retained inside the patient? if so, was it removed and how? 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 unknown procedure on an unknown date and mesh was used.A product defect was reported in which the unspecified plastic could not be pulled out.There were no adverse patient consequences reported.Additional information has been requested.

Manufacturer Narrative

(b)(4).Date sent to fda: (b)(6) 2020.Additional information was requested, and the following was obtained: confirmed that there was no part of plastic inside the patient.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

(b)(4).Date sent to fda: 01/14/2021.H3 analysis summary: the received device was manipulated.The implant was returned with the carton label, white plastic needles, helical passers and winged guide.Organic matter was visible on the different components.The mesh was not present.A functional test was performed to check if there was some issues to insert and pull out the helical passers inside the plastic needles and no blocking or other problem were detected.The reported event was not observed during the product evaluation.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.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: 10824058
• MDR Text Key: 216145999
• Report Number: 2210968-2020-08961
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2020

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: 02/28/2021
• Device Model Number: 810081
• Device Catalogue Number: 810081
• Device Lot Number: 3936356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 11/13/2020; 12/15/2020
• Supplement Dates FDA Received: 12/03/2020; 01/14/2021
• Removal/Correction Number: N/A
• Patient Sequence Number: 1