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

Model Number 810081L

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Additional information was requested and the following was obtained: please clarify how the product was defective: as indicated unk, no further info available.Status of product return: device at loc, shall be prepared for shipment.Evaluation: the received device was manipulated.The box was opened and folded and the anticounterfeit label was missing as well as the blister.A yellow post-it was in the plastic bag and a green inscription was written on the box.On the device, one needle tip was damaged, the plastic sheath was damaged at the basis of the needle.Organic matter was visible at the insertion of helical passer in the white needle.The mesh was twisted but in a good state.The defect on device seen during the product evaluation is aligned with the defect described in the event description.Nevertheless, the defect identified is not linked to a manufacturing issue.No non conformance will be opened.Events of this type are trended regularly, therefore this complaint is being closed to trending.

Event Description

It was reported that a patient underwent an unknown gynecological procedure on (b)(6) 2021 and the mesh was used.It was reported that the device was defective.Upon evaluation of the returned device, it was found that one needle tip was damaged, and the plastic sheath was damaged at the basis of the needle.There was no adverse patient consequences reported.Additional information was requested.

• Brand Name: GYNECARE TVT OBTURATOR W LASR
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12566572
• MDR Text Key: 274495411
• Report Number: 2210968-2021-09111
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 09/21/2021

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: 10/31/2021
• Device Model Number: 810081L
• Device Catalogue Number: 810081L
• Device Lot Number: 3937825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 10/03/2021
• 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