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

Catalog Number	POUCH
Medical Device Problem Codes	Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a robot surgery, upon removal at end of case, the bag broke inside the patient.Specimen fell out of bag and had to be removed without bag.Surgeon had to create a bigger incision to remove specimen.When specimen was retrieved, it was noted that a piece of plastic from the endopouch bag was attached to the specimen.Surgeon had to increase incision size to remove specimen.Near miss event that piece of plastic could have remained inside the patient.Near the end of the case, the robot was undocked and removed from patient.Surgeon was removing specimen which was contained within the ethicon endopouch retriever specimen bag 10mm, when the pouch broke inside the patient and the prostate specimen fell out of bag.Surgeon aware at time of incident, specimen bag was removed from patient and handed to scrub nurse.Surgeon had to remove specimen without bag and had to create a bigger incision site to remove specimen.When specimen was retrieved, it was noted that a piece of plastic from the endopouch bag was attached to the specimen.The piece of plastic was lined up with the specimen bag by scrub nurse and was noted to surgeon that the pieces lined up.Surgeon stated confident no pieces of bag were left inside patient.Photos of broken endopouch bag and piece of plastic taken and sent to incharge.Incharge then made aware after incident.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/9/2026.D4: batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.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.

• 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 ; * 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: 24293983
• Report Number: 3005075853-2026-01157
• Device Sequence Number: 18474711
• Product Code: GCJ
• UDI-Device Identifier: 10705036012986
• UDI-Public: (01)10705036012986(17)291231(10)404D12
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: POUCH
• Device Lot Number: 404D12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown