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

Catalog Number 810081

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent to the fda: 08/11/2017.The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Attempts have been made to retrieve the device.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 an unknown procedure on (b)(6) 2017 and the mesh was implanted.Prior to use, when the surgeon opened a box with the mesh, it was discovered that the mesh already appeared "cut".Another like device was used to conduct the procedure.There were no adverse patient consequences reported.No further information is available.

Manufacturer Narrative

Received was device with winged guide with two helical passers assembled to the implant assembly and the implant assembly cut in two pieces.The device received was manipulated.The mesh was cut.Based on the evaluation this complaint is not linked to a manufacturing issue.

• 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: 6789255
• MDR Text Key: 82774650
• Report Number: 2210968-2017-04763
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 07/25/2017

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: 02/28/2018
• Device Catalogue Number: 810081
• Device Lot Number: 3929288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2017
• Initial Date FDA Received: 08/11/2017
• Supplement Dates Manufacturer Received: 08/24/2017
• Supplement Dates FDA Received: 09/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2017
• 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