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 03/24/2017

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.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 following information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Please refer to the event description and clarify it.Are you saying that a portion of the mesh was fraying or was it falling apart when surgeon handled? was there an issue with the white trocar that covers the metal helical passer? please explain the following: please tell us what is the product complaint? what portion of the device was problematic for the customer for example was it the mesh, the helical passer.Please elaborate.Please explain the reference to intercurrences and increased bleeding? why was there increased bleeding, what is the increased bleeding associated with? if there was increased bleeding provide quantitative amount of blood loss? if the blood loss being reported is associated with the surgical procedure are you indicating that the amount of blood lose is outside what would be considered normal or expected for this type of surgical procedure since it was reported that the event occurred intraoperative? was the bleeding associated with the product difficulty you are reporting? please elaborate on the conclusion drawn if you answered yes? what was done to address the bleeding, was there any medical or surgical intervention to control the bleeding? how was the procedure completed? what was the procedure performed, was it a sling procedure? any pictures of the device difficulty or any pictures associated with this event? please confirm that this device is available for return/evaluation?.

Event Description

It was reported that the patient underwent an unknown gynecological surgical procedure on (b)(6) 2017 and the mesh was implanted.During the procedure, a passage of the screen was made and adjusts of the same without intercurrences.It was reported also that in the review, a construction of the mesh was loosened on one side with texture to the normal pattern increasing bleeding on the side with a changed mesh.Additional information has been requested.

Manufacturer Narrative

Additional information was requested and the following was received: please refer to the event description and clarify it.Are you saying that a portion of the mesh was fraying or was it falling apart when surgeon handled? was there an issue with the white trocar that covers the metal helical passer? during the surgery was done normal procedure, in the final revision in surgery was found that the screen was not fixed and there was excessive bleeding.The doctor did not use the kit passer, the doctor has his own.Please explain the following: please tell us what is the product complaint? loosened screen and screen deterioration.What portion of the device was problematic for the customer for example was it the mesh, the helical passer.Please elaborate.Mesh was tearing apart.Please explain the reference to intercurrences and increased bleeding? the mesh loosens and bleeding occurs.Why was there increased bleeding, what is the increased bleeding associated with? not informed.If there was increased bleeding provide quantitative amount of blood loss? the quantity was not measured.If the blood loss being reported is associated with the surgical procedure are you indicating that the amount of blood lose is outside what would be considered normal or expected for this type of surgical procedure since it was reported that the event occurred intraoperative? out of the ordinary, a doctor with great experience in the use of tvt, moderate blood excess.Was the bleeding associated with the product difficulty you are reporting? please elaborate on the conclusion drawn if you answered yes? yes, the mesh was tearing apart.What was done to address the bleeding, was the any medical or surgical intervention to control the bleeding? it was redone in the surgery at the moment of the intercurrence using the prolene screen 30 x 30.Any pictures of the device difficulty or any pictures associated with this event? no.

Manufacturer Narrative

The device received was manipulated.The mesh was cut at the level of white plastic sheets, and frayed, the needles tips were damaged.Based on the evaluation this complaint is 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: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6504622
• MDR Text Key: 73238501
• Report Number: 2210968-2017-03383
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 03/29/2017

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: 05/31/2017
• Device Catalogue Number: 810081
• Device Lot Number: 3915236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/19/2017
• Supplement Dates Manufacturer Received: Not provided; 09/04/2017
• Supplement Dates FDA Received: 05/09/2017; 09/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2016
• 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