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

Catalog Number	B12LT
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 4/2/2026.D4: batch # a97j7l.Investigation summary.The product was returned to ees for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that the b12lt device was returned with the sleeve tip crushed.Additionally, the opened packaging was returned along with the instrument.During evaluation, it was observed that the universal seal latch was engaged with the sleeve assembly.Upon further inspection of the device, damage to the sleeve tip was confirmed.Due to the condition of the returned device, no functional testing could be 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 might have caused the reported event.The reported complaint was confirmed.Device history review.A manufacturing record evaluation was performed for the finished device batch a97j7l number, and no non-conformances were identified.Additional information was requested and the following was obtained: any visible broken part? -no.What part broke of the device broke? -sleeve cracked.Did the damage occur right out of the packaging or in the operative field? -in the operative field.Did any pieces fall into the patient? -no.Will all pieces be returned with the device? -yes.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 the unk surgery, noted that the device was cracked.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.

• 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: 24769885
• Report Number: 3005075853-2026-02477
• Device Sequence Number: 9267171
• Product Code: GCJ
• UDI-Device Identifier: 10705036001164
• UDI-Public: (01)10705036001164(17)300228(10)512D59
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 04/02/2026

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: B12LT
• Device Lot Number: 512D59
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2025
• 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