MAUDE Adverse Event Report: CONMED ANCHOR TISSUE RETRIEVAL SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	TRS100SB2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.(b)(4).Per the instructions for use, the user is advised only physicians trained in the techniques of laparoscopic or minimally invasive surgery and the use of retrieval bags to remove tissue should use the product.Care should be taken when using sharp and electro-surgical devices.Note the size of the trocar cannula when removing a specimen through the trocar cannula and seal system.If required, enlarge the port site to aid removal of the anchor¿ tissue retrieval system¿ by conmed.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the trs100sb2 anchor tissue retrieval system, device was being used on (b)(6) 2026 during a lap chole procedure when it was reported was reported ¿during the retrieval of gall bladder from the patient, the bottom side of the bag broke.Gall bladder slipped out from the bag and ruptured.Surgeon has to ¿manually¿ retrieval the gall stone from patient body¿.Further assessment questioning found that the gallbladder did rupture causing contamination, however, no medical/surgical intervention was required for the patient.The procedure was completed and there was no report of injury, medical intervention or extended hospitalization for the patient or user.This report is being raised on the reported injury due patient gallbladder rupturing causing contamination.

• Brand Name: ANCHOR TISSUE RETRIEVAL SYSTEM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED; 525 french road; utica NY 13502
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 24647536
• Report Number: 3007305485-2026-00043
• Device Sequence Number: 9842608
• Product Code: GCJ
• UDI-Device Identifier: 20653405986109
• UDI-Public: (01)20653405986109(17)280910(10)202509114
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K172940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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: TRS100SB2
• Device Lot Number: 202509114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic