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	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 12/18/2025.D4: batch # unk.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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 during an unknown surgery, a black fragment was come off from the insertion hole.Since the fragment was able to be retrieved, there is no risk of it remaining inside the body.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: 1/22/2026.D4: batch # a97z0f.Investigation summary: the product was returned to ees for evaluation.Visual inspection and was conducted on the returned device.Visual analysis of the returned sample determined that the 2h12lp device was returned with no damage in the external components.The device was disassembled in order to evaluate the condition of the seal.Upon disassembling, the seal was found damaged and torn.As part of ees quality process all devices are manufactured, inspected, and released to approved specifications.Use caution when introducing or removing instruments through the trocar sleeve in order to prevent inadvertent damage to the seals which could result in loss of pneumoperitoneum.Special care should be used when inserting sharp or angled edged endoscopic instruments to prevent tearing the seal.Device history review: a manufacturing record evaluation was performed for the finished device batch a97z0f 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: 23843412
• Report Number: 3005075853-2025-09666
• Device Sequence Number: 9572071
• Product Code: GCJ
• UDI-Device Identifier: 10705036014256
• UDI-Public: (01)10705036014256(17)300430(10)A97Z0F
• 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): 01/22/2026

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 Catalogue Number: 2H12LP
• Device Lot Number: A97Z0F
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2025
• 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