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

Model Number 810081

Device Problem Break (1069)

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

Event Date 01/18/2023

Event Type  malfunction  

Manufacturer Narrative

Pc-(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: neuchâtel team received for evaluation a product tvto device (product code 810081), batch 3941740.The product was decontaminated.The received device was manipulated, as the original packaging was missing (box, blister/ lid, ifu, identification labels).It was returned the blue mesh with the sheath, the needles attached to the handles, and the winged guide.Also the returned device presented organic matter over it.Evaluation of received device: winged guide: was found damage free, only traces of organic matter were detected during the evaluation.Both handles were found damage free, only traces of organic matter were also detected during the evaluation.The two plastic needles: it was observed both needles were severely damaged.Both needle tips have impacts, one tip was presenting a hole.Both needles passing slots are bent.One needle has been moved from its original tunnel place.Blue mesh: it was observed that several stitches were broken on the edges of the mesh, the mesh has been extended.It has been observed on one mesh and one plastic sheath were presenting a cut at an angle.The sheaths were presenting many cracks, and cuts.The defect described in the event description is not aligned with the defects observed during the product evaluation, as mesh and sheath were clearly cut at angle.Therefore, the defects identified during the product evaluation are not linked to a manufacturing issue.A manufacturing record evaluation was performed for the finished device batch, and no related non-conformances were identified.

Event Description

It was reported that a patient underwent transvaginal anterior urethral mid-suspension via closed hole on (b)(6) 2023 and mesh was implanted.During insertion of the spiral needle, one of the device components was fractured while pushing the device inward through the obturator membrane (the fractured part was outside the patient's body).Immediately after the breakage, the surgeon removed the spiral needle and confirmed that the broken device was intact and that no foreign material remained in the patient's body before replacing it with a new product from the same batch and continuing the surgery without incident.The patient is recovering well and has been discharged from the hospital without any harm, except for the prolonged operation time (the exact duration of prolongation is unknown).No subsequent adverse events have been reported.The surgeon reported that during the inward advancement of the device, "the spiral needle was very soft and could not be effectively advanced inward.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: 16681192
• MDR Text Key: 313512139
• Report Number: 2210968-2023-02364
• 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: Other,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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 810081
• Device Catalogue Number: 810081
• Device Lot Number: 3941740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2022
• 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
• Patient Age: 55 YR
• Patient Sex: Female