MAUDE Adverse Event Report: ETHICON INC. MERS TAPE WHT 12INX3/16IN D/A CTX; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	RS22
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) h6 component code: g07002 - device not returned.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The following information was requested, but unavailable: was there any adverse consequence associated with the patient? - what is the current status of the patient? received information as following from sales rep via phone today.Please refer to the event description, other information requested is unknown.
Event or Problem Description
It was reported that a patient underwent a laparoscopic uterine isthmus cerclage surgery on (b)(6) 2024 and suture was used.During the procedure, the patient's vaginal cervical cerclage failed, and suture was used during the laparoscopic uterine isthmus cerclage surgery.During the surgery, when the needle had completely penetrated the tissue of the uterine isthmus, the suture slightly exposed the tissue.The doctor continued to pull the suture out of the tissue by pulling the needle body, the problem of pulling off suture needle happened.Immediately, a needle holder was used to straighten the needle body and remove it.The suture that leaked out of the organization was relatively short, and the doctor continued to pull the exposed short head to pull out the suture and tie it.The problem of pulling off suture needle happened in this case is considered fortunate.If the suture sometimes detaches before it penetrates the tissue, it may require a second puncture for the patient, resulting in increased bleeding.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: MERS TAPE WHT 12INX3/16IN D/A CTX
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21427744
• Report Number: 2210968-2025-01875
• Device Sequence Number: 20774502
• Product Code: GAT
• UDI-Device Identifier: 10705031049802
• UDI-Public: (01)10705031049802(17)290531(10)101SE4
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/20/2025

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 Catalogue Number: RS22
• Device Lot Number: 101SE4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2024
• 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
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female