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

Catalog Number 810081L

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

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.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.Lot # were there any patient consequences?.

Event Description

It was reported that the patient underwent an unknown procedure on (b)(6) 2017 and mesh was used.During the procedure, with retraction the mesh frayed and split in the middle and was ineffective.The procedure was completed with a like device.Additional information has been requested.

Manufacturer Narrative

One device was received for evaluation lot 3928838, product code(b)(4) with 2 helical passers and 2 white plastic needles.The device received was manipulated and used, blood stains were present on the received components, the mesh was cut from the white plastic needles and is missing for the evaluation, mark of clamps are visible on the needles.Without the mesh, no conclusion can be done.The defects of mesh cut, clamp marks seen during the product evaluation are not linked to a manufacturing issue.

Manufacturer Narrative

The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

• Brand Name: GYNECARE TVT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.; ethicon sarl-neuchatel; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 6817959
• MDR Text Key: 83645671
• Report Number: 2210968-2017-70045
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 810081L
• Device Lot Number: 3928838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/02/2017
• Initial Date FDA Received: 08/24/2017
• Supplement Dates Manufacturer Received: 09/05/2017; 09/13/2017
• Supplement Dates FDA Received: 09/12/2017; 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1