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

Catalog Number 810081

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent to the fda: 04/28/2017.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.Please clarify the statement you made in file (b)(4), indicating related events: (mx001512) - (b)(4) and (mx001577) - (b)(4).As noted below each event occurred at a different time, which would indicate 3 different patient¿s thus the events cannot be related.If they are related please explain how and note that similarities in events do not relate files? what was the lot number of the device you are reporting? quantity indicates ni.Did the surgeon use one device that was noted to have a portion that detached? it was reported that a portion of the device detached during use.It is hard to tell in the picture you sent what specifically detached.Please explain did the mesh detach from the white sheath that covers the helical passer or did the centering loop detach or did the white sheath break or crack? will the device be returned, two different answers were marked on the complaint form?.

Event Description

It was reported that the patient underwent an unknown procedure on (b)(6) 2017 and the mesh was implanted.During use a portion of the device was detached.The procedure was completed with another like device.There were no adverse patient consequences reported.Additional information has been requested.

Manufacturer Narrative

Additional information was requested and the following was received: please clarify the statement you made in file (b)(4), indicating related events: ((b)(4).As noted below each event occurred at a different time, which would indicate 3 different patient¿s thus the events cannot be related.If they are related please explain how and note that similarities in events do not relate files? i commented that it was only a report that includes patient.What was the lot number of the device you are reporting? ni.Quantity indicates ni.Did the surgeon use one device that was noted to have a portion that detached? no, the surgeon did not know that the mesh had a defect of surgeon.It was reported that a portion of the device detached during use.It is hard to tell in the picture you sent what specifically detached.I don´t know how to call him to the edge of the mesh.According to what the surgeon says, it was the blue part.Will the device be returned, two different answers were marked on the complaint form? no.

Manufacturer Narrative

No conclusion.The product evaluation has been done only with pictures.The product has not been sent for evaluation and the lot number is unknown.During production, inspections are performed by trained and certified operators to verify the mesh integrity and the presence of foreign matter or the size of particle belonging to product.During the surgery, the mesh was stretched, damaged.

• 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: 6529277
• MDR Text Key: 74045333
• Report Number: 2210968-2017-03481
• 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,Followup,Followup
• Report Date: 04/12/2017

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 Catalogue Number: 810081
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2017
• Initial Date FDA Received: 04/28/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/09/2017; 05/30/2017
• 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