MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. ENDOPATH XCEL; Laparoscope, General and Plastic Surgery

Catalog Number	B12SRT
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an unknown surgery, a thin black part came off during the procedure.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).B3: unknown; captured as awareness date.Date sent 9/24/2026.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.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 information was requested, and the following was obtained: during the visual inspection, japan qa identified damage to the trocar's external seal and confirmed that a seal fragment had detached from the seal.Could you please provide the lot #/batch #? unk.Please provide more details about the device quality issue of b12lt.Any visible broken part? a part of the black seal detached.What part broke of the device broke? black seal.Could you please specify how the device was damaged? the black seal was damaged and the fragment fell off.Did the damage occur right out of the packaging or in the operative field? the operative field.Did any pieces fall into the patient? unk if yes, were they retrieved? will all pieces be returned with the device? yes.

• Brand Name: ENDOPATH XCEL
• Common Device Name: Laparoscope, General and Plastic Surgery
• Manufacturer (Section D): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer (Section G): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; PR ; +1(303)552-6892
• MDR Report Key: 50881732
• Report Number: 3005075853-2026-07922
• Device Sequence Number: 9939273
• Product Code: GCJ
• UDI-Device Identifier: 10705036001188
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial

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: B12SRT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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