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

Catalog Number 810081

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.It was reported that the tape snapped.Provide the following: when did the tape snap, intra-op (during use on patient), pre-op, post-op? when you say the tape snapped do you actually mean the mesh or another part of the device, please elaborate? what actually occurred with the mesh, what do you mean by snapped for example did the mesh tear during implanting again please elaborate? the event implicates one device yet three are reported and three are returning.Explain how many devices actually presented with a difficulty? is the customer attempting to return unused product, that was not opened? lot number of all devices involved in the event? what was the name of the procedure? how was the procedure completed? confirm no patient consequences.

Event Description

It was reported that the patient underwent an unknown procedure and the mesh was used.It was also reported that the mesh snapped.There were no patient consequences reported.Additional information has been requested.

Manufacturer Narrative

Pc-(b)(4).Received for evaluation gynecare tvt unk device.The device received was manipulated.Mesh of the gynecare tvt device was damaged and stretched.Organic substances are visible on the device.The defect seen during the product evaluation is aligned with the defect described in the event description (damaged mesh).The defect identified is not linked to a manufacturing issue.

• Brand Name: GYNECARE TVT OBTURATOR
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7121059
• MDR Text Key: 95455897
• Report Number: 2210968-2017-71817
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• 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: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 810081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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