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

Catalog Number	810081
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a sling procedure on (b)(6) 2025 and mesh was used.The mesh was used during the surgery, and the surgeon reported that it broke when pulled, making it impossible to use and hang.Changed to another one to complete the surgery.There were no adverse patient consequences.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (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 was requested and the following was obtained: can you identify the lot number of the product used? no, please refer to the device returned.Were there any patient consequences? if yes, what was the treatment? no.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
Product complaint # (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.Corrected information:: d3.Additional information: d4, d9, h3, h4, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional h3 investigation summary: it was received for evaluation one product of gynecare obturator product code 810081 and lot number 3944875.An investigation was performed on received product and on the batch record file.The product was decontaminated and well packaged.The device was opened and manipulated as the original packaging was missing.The following items were returned: 2 needles, 2 part of the mesh prolene line, 2 helical passers and lid and a label that is not part of the manufacturing site.The box and ifu are missing.No damage was observed on the lid, the label attached to the lid corresponds to lot 3944975 with the label attached to the blister.Winged guide, needles, helical passer, mesh prolene and plastic sheat are surrounded with lot of visible organic material.The marks of sealing transfer are visible on lid, concluding that the device packaging was sealed correctly.The mesh has been stretched, cut in half, and separated from the needles.The needles have been removed from the helical passers and no damage is observed on the needles or the tips.Based to the evaluation, this complaint is not related to a manufacturing problem.The defect observed during the evaluation corresponds to the description of the event: the complaint is confirmed, but it is not related to manufacturing.The product was conforming to specifications at the release.Three pictures were provided, the mesh can be seen damaged/broken.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: GYNECARE TVT OBTURATOR
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace drive; westlake village CA 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22396215
• Report Number: 2210968-2025-07857
• Device Sequence Number: 4901278
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: (01)10705031000346(17)250731(10)3944875
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Catalogue Number: 810081
• Device Lot Number: 3944875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Female