MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT ABREVO CONTINENCE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number TVTOML

Device Problems Bent (1059); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.The following information was requested, but unavailable: please confirm that the helical passer was bent and not the white plastic sheath that covers the helical passer that was bent ? if it was the helical passer was it bent prior to use or did it bend during use? the device was manipulated but does not seem to have been used, placed in the body: traces of blood are present on the plastic sheath but not on the mesh.The plastic needles are not bent and are correctly assembled to the helical passers.Only a damaged needle tip was observed during the product evaluation.The defect identified during the investigation is not linked to the manufacturing process.

Event Description

It was reported that the patient underwent an unknown procedure on (b)(6)2016 and the mesh was implanted.It was also reported that during the procedure, helix was bent but the surgeon tried to accomplish the procedure nevertheless with this device but failed and had to replace it during use on the patient with same like device in order to finish the procedure successfully.There was no harm for the patient.During the device evaluation, the damaged needle tip was found.Additional information has been requested.

• Brand Name: GYNECARE TVT ABREVO CONTINENCE SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 6747304
• MDR Text Key: 81191854
• Report Number: 2210968-2017-33164
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K100936
• 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: 03/11/2016

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: 08/31/2016
• Device Catalogue Number: TVTOML
• Device Lot Number: 3869571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/11/2017
• Initial Date FDA Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2015
• 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