MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPOUCH RETRIEVER SPEC BAG; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	POUCH
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a gall bladder removal, endopouch retriever in patient, removing the gallbladder when it ripped.No patient consequences or delay in the procedure were reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/5/2026 d4: batch # unk d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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.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.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/5/2026.D4: batch # a98l5n.Investigation summary: the product was returned to ees for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the pouch device was received fully deploy.In addition, the packaging opened was returned along with the instrument.The device was disassembled and no anomalies could be observed.The suture and the bag were not returned for analysis.It could not be determine what may have cause the reported event.As part of ees quality process all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what may have caused the reported incident.Device history review a manufacturing record evaluation was performed for the finished device batch a98l5n number, and no non-conformances were identified.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: ENDOPOUCH RETRIEVER SPEC BAG
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 24267610
• Report Number: 3005075853-2026-01036
• Device Sequence Number: 13426459
• Product Code: GCJ
• UDI-Device Identifier: 10705036012986
• UDI-Public: (01)10705036012986(17)300731(10)741D60
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011501
• 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): 03/05/2026

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: POUCH
• Device Lot Number: 741D60
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2025
• 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