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 Date 03/25/2017

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.The single complaint was reported with possible multiple events.There are no additional details regarding the additional events.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.Additional information was requested and the following was obtained: please explain the event description which states the following: the parts that comes in the bank of the mesh is peeling.The total of devices are ten, not only one.They are located in the hospital, only one was retired.- a mat, small dimensions and shaped part of circle, is loose, in some cases there is not one but several what exactly occurred with the device, was the mesh fraying, was it torn, did the mesh fall apart or was the issue with the white trocar that covers the helical passer? we need clarification may be fda reportable, please identify the part of the product that had the reported difficulty? -a part the mesh fraying.It seems suture that lies on the edge of the mesh.Was the primary packaging on the device/devices intact? was the device/ devices still sterile, meaning that the primary packaging was not compromised, including device seal? - it was the primary packaging in the appliance/device intact.Did the event involve one single patient/one surgeon/one procedure? if so was there a scheduled procedure, if yes provide the name of procedure? was the patient in the operating room when the product difficulty was noted or event occurred?- there is no patient involved the defect identified in the area of supply.It was reported that a total of 10 devices (product code 810081) had an issue.This product comes one device per box please again confirm that 10 devices all had the same reported difficulty? - ni.If more then one device please confirm that all 10 devices were from lot 3907561? ni.Who was the device/devices stored? ni.It was reported that one of the devices was retired, so you mean? ni.If 10 devices (b)(4) were involved why is only 1 reportedly being returned? ni.Provide any pictures of all devices involved, highlight the reported device difficulty? ni.Received: the product was well packaged.No failure was identified on the mesh during the product evaluation.No defect was found on the mesh.

Event Description

It was reported that prior to unknown procedure on unknown date, a part of the mesh was fraying/peeling.There was no patient involved and the defect was identified in the area of supply.The primary packaging in the appliance/device was intact.

• 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: 6549137
• MDR Text Key: 74654832
• Report Number: 2210968-2017-03556
• 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: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• 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: 3907561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1