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 Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 12/15/2025 b3: exact event date unk, entered 1/1/2025 as only the year was provided.D4: batch # unk attempts have been made to retrieve the device.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Additional information was requested and the following was obtained: ·the base of the stopcock was removed cleanly.It looked that the adhesive came off and it separated cleanly rather than the base of the stopcock valve was broken.Was there physical damage to the trocar?=>yes please specify part of trocar.=>stop cock was the tip of the trocar obturator broken?=>no if yes, was it separated from the device?=>na if yes, did it fall into the patient =>na was there an issue related to inserting the trocar?=>no was there an issue with a seal?=>no was there an issue with the trocar sleeve?=>no was there an insufflation issue?=>no please provide more product issue detail.The procedure was a laparoscopic incisional hernia repair.The connection part of 2h12lp was broken when the pneumoperitoneum tube was replaced during surgery.The device was used on the umbilical region.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.
Event or Problem Description
It was reported that, during an unknown laparoscopic surgery, the issue has reported, but the details are unknown at this time, so it is being confirmed.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: 1/20/2026 d4: batch # a9840z.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 2h12lp device was returned with the stopcock detached from the sleeve assembly and olive plug assembly inside aplastic bag.Upon visual inspection, no damages or evidence of breakage were noted in the stopcock.Due to the returned condition of the instrument, no further testing was performed.As part of ees quality process all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what may have caused the detachment of the stopcock from the sleeve.Device history review a manufacturing record evaluation was performed for the finished device batch a9840z number, and no non-conformances were identified.

• 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 23801700
• Report Number: 3005075853-2025-09467
• Device Sequence Number: 7732304
• Product Code: GCJ
• UDI-Device Identifier: 10705036014256
• UDI-Public: (01)10705036014256(17)250529(10)A9840Z
• 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,Followup
• Report Date (Section B): 01/20/2026

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: 05/29/2025
• Device Catalogue Number: 2H12LP
• Device Lot Number: A9840Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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