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

Catalog Number	B5LT
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 4/10/2026.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.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 before an unk procedure, a foreign material which appears to be a hair was identified in an unopened package of the product.Issue was identified prior to a procedure and no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/23/2026.Investigation summary : the product was returned to ees for evaluation.Visual inspection was conducted on the returned device.Visual inspection of the returned b5lt device confirmed that it was received unopened and contained within its original sterile packaging, with no apparent damage to the packaging or device.During examination of the sterile package, a hair was observed inside the packaging.Additionally, a photograph was provided that documented and confirmed the same condition observed upon receipt of the sample.As part of ees quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on how the foreign matter was introduced inside the sterile package, it is possible that the hair adhered to the device during the packaging process due to static.The reported complaint was confirmed.Device history review a manufacturing record evaluation was performed for the finished device lot 781d46 number, and no non-conformances were identified.

• Brand Name: ENDOPATH XCEL
• 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: 24847298
• Report Number: 3005075853-2026-02734
• Device Sequence Number: 14865785
• Product Code: GCJ
• UDI-Device Identifier: 10705036001225
• UDI-Public: (01)10705036001225(17)300930(10)781D46
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: B5LT
• Device Lot Number: 781D46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2025
• 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