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

Catalog Number 810081

Device Problem Delamination (2904)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2017

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.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.Additional information was requested and the following was obtained: it was reported the product disarms, loss of mesh properties.Please explain what you are referring to, do you mean one of the following, please explain: did the mesh detach from the positioning lines? - the mesh breaks down at the moment of touching it.Did the positioning lines detach from the white trocar that covers the helical passer? -the issue is referred to the stiffness of the mesh.It was not reported if the device was available for return please advise? the device will be returned.Was the sterility compromised? no, it was handled as the instructions indicated.Was the packaging not properly sealed? no, it was handled as the instructions indicated.Was the product received with the cover damaged out? no, the box was in good condition.Did the event occur when the product was being opened? no, the event occurred during its use.Was there difficulty opening the product? no, the procedure and the opening of the product didn´t have any inconveniences.You indicated that the mesh would be returned, is the packaging going to accompany the device? no, not the box.The hospital threw it away.

Event Description

It was reported that the patient underwent an unknown procedure on (b)(6) 2017 and the mesh was implanted.During the procedure, the mesh broke down at the moment of touching it.It was also reported that the issue was referred to the stiffness of the mesh.There were no adverse patient consequences reported.Another like device was used to complete the procedure.

Manufacturer Narrative

Parts of one device of lot #3919242, product code 810081 was received with 2 plastic needles , 2 helical guides, the mesh cut, a part of plastic sheath.The device received was manipulated and used.The mesh was detached from the plastic needles and cut.The mesh was frayed, damaged.The defect was 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: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6388410
• MDR Text Key: 69439439
• Report Number: 2210968-2017-01786
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: 01/10/2017

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: 06/30/2017
• Device Catalogue Number: 810081
• Device Lot Number: 3919242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 03/08/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2016
• 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