MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT BLUNT TIP 12X100 SMOOTH; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	2H12LP
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an unknown urological surgery, when tried to puncture the trocar, a part was broken.Fragments have also been retrieved.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/4/2025.B3: exact event date unk, entered (b)(6) 2025 as only the year was provided.D4: batch # unk.Investigation summary: the product was returned to ees for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that only the sleeve from the 2h12lp device was returned with the olive plug assembly damaged.The broken part of the olive plug assembly was returned inside a plastic bag.The cam component was not returned.A manufacturing record evaluation was performed for the finished device lot 137d79 number, and no non-conformances were identified.As part of ees quality process all devices are manufactured, inspected, and released to approved specifications.It is possible that the damage to the olive plug assembly was due to improper handling of the device.Device history review: a manufacturing record evaluation was performed for the finished device lot 137d79 number, and no non-conformances were identified.Additional information was requested and the following was obtained: which part of the device was damaged/broken? (handle/shaft/jaws).Adjustable locking cam of the olive plug.Is the piece returning or was it discarded? the adjustable locking cam was discarded, but the damaged part would be returning.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, or its employees that the report constitutes an admission that the product, ethicon, 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.

• Brand Name: OPT BLUNT TIP 12X100 SMOOTH
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 23715493
• Report Number: 3005075853-2025-09175
• Device Sequence Number: 13326947
• Product Code: GCJ
• UDI-Device Identifier: 10705036014256
• UDI-Public: (01)10705036014256(17)270531(10)137D79
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2025

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: 2H12LP
• Device Lot Number: 137D79
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• 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 Sex: Unknown