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	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2026
Type of Reportable Event	Malfunction

• 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: 50209844
• Report Number: 3005075853-2026-06509
• Device Sequence Number: 17666757
• Product Code: GCJ
• UDI-Device Identifier: 10705036012986
• UDI-Public: (01)10705036012986(17)310331(10)969D30
• 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: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: 969D30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2026
• 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