MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	CB12LT
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a bariatric procedure (gastric bypass), the trocar was placed and used according to standard instructions for use.The white plastic lumen is located at the proximal opening of the trocar.After prolonged use of 5 mm instruments within a 12 mm trocar, the white lumen remained displaced off-center.Under normal conditions, the lumen should return automatically to its original position, in which it is no longer visible at the opening.Due to this malfunction, the lumen did not immediately return to its normal position after instrument removal.As a result, insertion of a 12 mm instrument (such as a stapler) was not possible without additional manipulation.The lumen first had to be manually repositioned (pushed back) before the stapler could be inserted and positioned correctly.No patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/11/2026.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.An analysis of the product could not be performed since a physical sample was not received for evaluation.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.

• Brand Name: ENDOPATH XCEL
• 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: 25475434
• Report Number: 3005075853-2026-04503
• Device Sequence Number: 9933276
• Product Code: GCJ
• UDI-Device Identifier: 10705036001331
• UDI-Public: (01)10705036001331(17)UNK(10)UNK
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K032676
• 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): 06/11/2026

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: CB12LT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/11/2026
• 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