MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY ANCHOR TISSUE RETRIEVAL SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	TRS-ROBO-8
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the device, trs-robo-8, anchor tissue retrieval system, was being used during a diagnostic laparoscopy, laparoscopic cholecystectomy procedure on (b)(6) 2025 when it was reported, ¿the robotic specimen retrieval bag has been ripping at the seams.¿.Further assessment found the bag did rip during use.There was no fragmentation left behind.There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed using a same product device.There was no report of any delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The customer reported that the device, trs-robo-8, anchor tissue retrieval system, was being used during a diagnostic laparoscopy, laparoscopic cholecystectomy procedure on (b)(6) 2025 when it was reported, ¿the robotic specimen retrieval bag has been ripping at the seams.¿.Further assessment found the bag did rip during use.There was no fragmentation left behind.There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed using a same product device.There was no report of any delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event 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.A two-year lot history review shows a total of six (6) devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 47 complaints, regarding 54 devices, for this device family and failure mode.During this same time frame 910,225 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.00006.Per the instructions for use, the user is advised to not use the anchor¿ tissue retrieval system¿ if resistance is met upon deployment.Improper use of the anchor¿ tissue retrieval system¿ may result in perforation of tissue and subsequent bleeding.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.

• Brand Name: ANCHOR TISSUE RETRIEVAL SYSTEM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 21889574
• Report Number: 3007305485-2025-00069
• Device Sequence Number: 11645481
• Product Code: GCJ
• UDI-Device Identifier: 20653405986147
• UDI-Public: (01)20653405986147(17)280120(10)202501204
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

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: TRS-ROBO-8
• Device Lot Number: 202501204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2025
• 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
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic