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

Model Number 810081

Device Problem Use of Device Problem (1670)

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

Event Date 09/23/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Analysis summary: the received device was manipulated, as original packaging and several components were missing (box, ifu, blister, part of the mesh).Only the lid, 2 trocars, 2 needles with partial blue mesh attached, and the atraumatic winged guide were returned.It can be observed that organic matter is visible over the returned sample.One needle has the slot damaged, the remaining blue mesh parts were wrinkled, damaged and small part was frayed, it can also be observed that each remaining mesh were properly cut without being thorned.The defect identified is not linked to a manufacturing issue.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.

Event Description

It was reported that patient underwent a urinary incontinence procedure on (b)(6)2022 and mesh was used.The device was damaged and dropped in patient during the procedure.The physician put much efforts to retrieve damage piece from patient.The procedure was prolonged around 1 hour.There were no adverse patient consequences reported.No additional information could be provided.

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information: h6.Photo analysis summary: neuchâtel team received for evaluation one photo of tvto device (product code 810081), batch 3940733.It can be observed the photo has been taken during an operation procedure: the device has been opened and manipulated as there was no box and no blister.The photo shows one needle and part of the mesh are present.Additionally, organic matter can be seen over the mesh.The defect seen during the photo evaluation could not been observed because the greatest part of the mesh is missing.The defect identified is not linked to a manufacturing issue.Events of this type are trended regularly.

• Brand Name: GYNECARE TVT OBTURATOR
• 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 ; 9083863534
• MDR Report Key: 15989892
• MDR Text Key: 308157710
• Report Number: 2210968-2022-10320
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: 10705031000346
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 12/31/2022
• Device Model Number: 810081
• Device Catalogue Number: 810081
• Device Lot Number: 3940733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 12/19/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1