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

Catalog Number 810081

Device Problem Material Integrity Problem (2978)

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

Event Date 08/03/2023

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.H3 analysis summary: neuchatel team received for evaluation one products of gynecare product code 810081 lot number 3944065.The product was decontaminated and well packaged.The received device was manipulated as the original packaging was opened.It was returned the device (needles, mesh, helical passers, winged gide) and packaging components (lid, blister, box and ifu).In the received box, it was observed some damages on opening area with tape stuck.Also, a label is stuck in one side of the box, this label is not part of neuchatel manufacturing.No damages were found in the lid, and it corresponds to lot 3944065 at the complaint origin.The ifu was also returned, and no damages were observed.No damages were found in blister, the sealing transfer is visible and without defects, concluding that the device packaging was sealed correctly.The mesh, plastic sheath, needles, helical passers and winged gide have visible organic matter around.Also, a damage can be observed in one needle tip and associate plastic sheath.The plastic sheath was found torn just before the junction with the needle and the needle tip broken.No other damages were detected.Based on the evaluation, this complaint is not linked to a manufacturing issue.The product was conforming to specifications at the release.Events of this type are trended regularly.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2023 and mesh was used.The needle part was lumpy and does not penetrate well.There were no adverse patient consequences reported.No further information was provided.

• 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: 18905295
• MDR Text Key: 337752367
• Report Number: 2210968-2024-03075
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: 10705031000346
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 810081
• Device Lot Number: 3944065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2023
• 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