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	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 6/11/2026 d4: batch # 653d55.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.A manufacturing record evaluation was performed for the finished device batch number of 653d55 / 42pouch, and no non-conformances were identified.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.Did any part of the pouch fall into the patient? if so, was the part retrieved? if a part broke off of pouch, is the part and the rest of the device being sent back for analysis? or was the torn portion disposed of? did the event occur during one or multiple patient procedures? what is the total number of procedures? have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).If this event occurred in multiple procedures, please create a product complaint for each event and provide the respective reference number.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 during an unk procedure, pouch breaking during surgery.Each time the bag split open while trying to remove it from the patient and the specimen has fallen back into the patient.There have been no adverse patient outcomes report due to these 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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 25478119
• Report Number: 3005075853-2026-04520
• Device Sequence Number: 13052646
• Product Code: GCJ
• UDI-Device Identifier: 10705036012986
• UDI-Public: (01)10705036012986(17)300630(10)653D55
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

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: 653D55
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 06/11/2026
• 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