MAUDE Adverse Event Report: ETHICON SARL GYNECARE TVT OBTURATOR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 810081

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information was requested and the following was obtained: a urological procedure was performed.Can you indicate what was the actual name of procedure for example sling? - it was a procedure to correct an urinary incontinence with sling.It was reported that the device failed.Please explain how the device failed for example did the mesh tear, was there damage to the white plastic sheath if so what? - the surgeon reported that once she passed the tvt she realized that the mesh was fraying and unraveling in the mesh edge (picture) how was the procedure completed? -the surgeon used another j&j tvto 810081.Confirm no patient consequences and confirm device disposed of?.- there was no patient consequence and the device was discarded no conclusion can be done for this complaint.No product was received for evaluation.An investigation was performed based on the batch records and on pictures.Based on the evaluation, this complaint is not linked to a manufacturing issue.The defect seen during the evaluation (mesh stretched, frayed) is aligned with the delamination or fraying nevertheless because the product has not been sent for evaluation, no conclusion can be done.

Event Description

It was reported that the patient underwent an unknown sling procedure for urinary incontinence on unknown date and the mesh was implanted.During the procedure, once the surgeon passed the mesh, it was noticed that the mesh was fraying and unraveling in the mesh edge.Another like device was used to complete the procedure.There were no adverse patient consequences reported.

• Brand Name: GYNECARE TVT OBTURATOR SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON SARL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6597712
• MDR Text Key: 76159664
• Report Number: 2210968-2017-03845
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 810081
• Device Lot Number: 3904068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2016
• 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
• Patient Age: 54 YR