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

Catalog Number	2H12LP
Medical Device Problem Codes	Crack (1135); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown laparoscopic surgery, the device was once removed to take a ¿specimen, and when trying to insert again, it was cracked.There was no effect on the patient.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 10/22/2025.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.B3: unknown; captured as awareness date.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.No lot or batch number was provided therefore a device history could not be done.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: could you please specify how the device was damaged? was the sleeve damaged? was the housing damaged? was there any seal damaged? any visible broken part? did any pieces fall into the patient? if yes, were they retrieved? 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.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/30/2025.Additional information received: 1.Could you please specify how the device was damaged? currently, unknown.We will attached the photos soon.2.Was the sleeve damaged? currently, unknown.3.Was the housing damaged? currently, unknown.4.Was there any seal damaged? currently, unknown.5.Any visible broken part? currently, unknown.6.Did any pieces fall into the patient? no.7.If yes, were they retrieved? n/a.The adjusting locking cam and its surrounding area were cracked.-the breakage occurred outside the body, so both the doctor and nurse think that there is nothing left inside the body.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/5/2025.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that only the sleeve from 2h12lp device was received.In addition, the cam and olive cap were returned inside aplastic bag.As each device is visually inspected and functionally tested during the manufacturing process, no conclusion could be reached as to what might have caused the reported event.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what might have caused the reported event.The damaged on the olive plug assembly , it is possible that the damaged was due to an improper handling of the device.Device history review he manufacturing records couldn't be reviewed as the batch number is unknown.Additional information was requested and the following was obtained: -the adjusting locking cam and its surrounding area were cracked.-the breakage occurred outside the body, so both the doctor and nurse think that there is nothing left inside the body.

• 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: 23356406
• Report Number: 3005075853-2025-08171
• Device Sequence Number: 8860996
• Product Code: GCJ
• UDI-Device Identifier: 10705036014256
• UDI-Public: 10705036014256
• 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,Followup
• Report Date (Section B): 12/05/2025

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
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 10/29/2025; 11/12/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 10/30/2025; 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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