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

Catalog Number	TB5LT
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unk procedure, before used on the patient, opened the packing, found the seal film damaged.Another device was used to complete the surgery.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/3/2026.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.Additional information was requested and the following was obtained: could you please specify how the device was damaged, was the sleeve damaged? was the housing damaged? was there any insufflation issue? was there any seal damaged? any visible broken part? -details could not be provided.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 Manufacturer Narrative
(b)(4).Date sent: 4/14/2026.D4: batch # a9dr1r.Investigation summary: the product was returned to ees for evaluation.Visual inspection was conducted on the returned device.Visual inspection of the returned sample revealed that the tb5lt device was received with the sleeve cap detached from the device.Its evaluation of the packaging showed no anomalies or evidence of damage related to the reported complaint.However, the sleeve cap was found separated from the device and appeared to be broken.As part of ees quality process all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached regarding what may have caused the reported incident.Device history review: a manufacturing record evaluation was performed for the finished device batch a9dr1r number, and no non-conformances were identified.

• Brand Name: ENDOPATH BASX
• 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: 24779622
• Report Number: 3005075853-2026-02494
• Device Sequence Number: 14985675
• Product Code: GCJ
• UDI-Device Identifier: 10705036003021
• UDI-Public: (01)10705036003021(17)280731(10)553C96
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062209
• 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): 04/14/2026

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: TB5LT
• Device Lot Number: 553C96
• 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: 03/15/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2023
• 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