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

Catalog Number	B5ST
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 12/15/2025.D4: batch#: unk.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Additional information was requested and the following was obtained: 1.Did the damage occur right out of the packaging or in the operative field? in the operative field.2.Was part of the packaging found to be damaged (tyvek, plastic/blister, packaging seal, etc.)? packaging seal.4.Could you please identify the packaging (shipping box, primary packaging, box, pouch seal, or the plastic bag)? pouch seal.5.Could you please clarify the type of damage found (broken, packaging was worn, bent, ragged, containing cut or slit, or appear ripped)? seal open.6.Was sterility compromised as a result of the packaging damage? 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, before used on the patient, noted the packing was damaged.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/8/2026 investigation summary the product was returned to ees for evaluation.Visual inspection was conducted on the returned packaging.Visual analysis of the returned sample determined that the b5st device was returned inside it's package opened.The package was visually inspected and no damaged was observed.As part of ees quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device was returned without detectable damage.Device history review a manufacturing record evaluation was performed for the finished device lot 628d47 number, and no non-conformances were identified.

• Brand Name: ENDOPATH XCEL BLADELESS TROCAR
• 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: 23804532
• Report Number: 3005075853-2025-09510
• Device Sequence Number: 7686595
• Product Code: GCJ
• UDI-Device Identifier: 10705036001232
• UDI-Public: (01)10705036001232(17)300531(10)628D47
• 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,Followup
• Report Date (Section B): 01/08/2026

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: B5ST
• Device Lot Number: 628D47
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2025
• 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