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

Model Number 810081L

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product complaint (b)(4).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Attempts were made to obtain a device for evaluation.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.

Event Description

It was reported that the patient underwent a sling procedure on unknown date and the mesh was implanted.It was reported that during the procedure, white handles were hard to place through.After the placement the handles were hard to remove.It was reported that the action user took to mitigate/ resolve problem during procedure.

Manufacturer Narrative

(b)(4).Date sent to fda: 05/01/2020.Additional information: d10.Additional h3 analysis summary: the device received was manipulated.The implant was returned without the blister, winged guide and its original packaging.A functional test was performed to try to remove the white handles from the white needle.One side was easily removable and the other side was harder to remove due to presence of organic substance on the device.No changes in the raw material specification were done.The defect identified is not linked to a manufacturing issue. .

• 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
• MDR Report Key: 9891500
• MDR Text Key: 197342220
• Report Number: 2210968-2020-02437
• 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
• Report Date: 03/02/2020

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: 02/29/2020
• Device Model Number: 810081L
• Device Catalogue Number: 810081L
• Device Lot Number: 3934124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/27/2020
• Supplement Dates Manufacturer Received: 04/14/2020
• Supplement Dates FDA Received: 05/01/2020
• Patient Sequence Number: 1