MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. ENDOPOUCH RETRIEVER; Laparoscope, General and Plastic Surgery

Catalog Number	POUCH
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Laceration(s) (1946); Foreign Body In Patient (2687)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that in the middle of an unknown surgery the pouch broke inside the patient and it lacerated their liver.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/22/2026.D4 batch # unk.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.B3: only event year known: 2026.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: regarding "lacerated their liver", how was the patient treated/addressed? could you please clarify if there were any patient consequences? could you please clarify if there were any change in the post-operative care of the patient as a result of the event?.

• Brand Name: ENDOPOUCH RETRIEVER
• Common Device Name: Laparoscope, General and Plastic Surgery
• Manufacturer (Section D): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer (Section G): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; PR ; +1(303)552-6892
• MDR Report Key: 50853668
• Report Number: 3005075853-2026-07844
• Device Sequence Number: 9497705
• Product Code: GCJ
• UDI-Device Identifier: 10705036012986
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K011501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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