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

Catalog Number 810081L

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.To date the device has not been returned.If the device or further details are received at the 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.Please specify what guide you are referring to on the tvt device.What do you mean by disintegrated? when you say the guide disintegrated are you indicating that the mesh was falling apart?.

Event Description

It was reported that the patient underwent an unknown procedure on unknown date and the mesh was implanted.During the procedure, the guide disintegrates at the moment of the passage.It was also reported that risk to break inside without the strip is positioned correctly.Additional information has been requested.

Manufacturer Narrative

Date sent to the fda: 08/14/2019 additional h-3 summary: received for evaluation one gynecare tvt-o device mesh and needle assembly.The device received was manipulated: the device is incomplete, only the mesh and needle assembly was returned.One plastic needle is broken.Organic substances are visible on the device.The defect seen during the product evaluation is aligned with the defect described in the event description (loss of integrity - device components become disassembled).No further investigation will be conducted on this complaint due to external cause.

Manufacturer Narrative

Date sent to the fda: 09/25/2019.Additional h-6 device code: 1069.Additional information was requested, and the following was obtained: the issue was related to the white sheath which covered the tip of the device (at the right side).It existed a little perforated area at about 2 cm from the internal prosthesis which allowed the device to curve.It is at this location where the device was torn, probably at the obturator membrane.The surgeon forced to retrieve the device, the tear spread and the plastic part distended.To avoid a significant issue, the surgeon removed the device and use another device to complete the procedure.

• Brand Name: GYNECARE TVT OBTURATOR W LASR
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8783402
• MDR Text Key: 150819370
• Report Number: 2210968-2019-84127
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• 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: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 810081L
• Device Lot Number: 3933514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Date Manufacturer Received: 09/11/2019
• Patient Sequence Number: 1