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 Codes	Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that the device, trs-robo-8, anchor tissue retrieval system, was used in a robot/lap chole procedure on (b)(6) 2025 and "anchor bags ripped upon exiting the patient with the specimen.No injury to the patient.¿.Further assessment found "failure of bag, seam split downside".No device fragments or portions of specimen fell into the patient.There was no contamination and no change in the wound classification, but "incision expanded to retrieve gallbladder, had to put in a fascial stitch.".The procedure was completed with a delay of "maybe 7 minutes to retrieve gallbladder and then close incision".There was "no extended stay, no long term affect to patient".This report is being raised due to the reported injury of extended incision requiring fascial stitch.
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Additional Manufacturer Narrative
Correction: a correction has been made to h6 clinical code.Additional manufacturer narrative: an examination of the returned used device trs-robo-8 found that the specimen bag was ripped at the seal.Examination was done of one device since the other device was not returned for examination.Root cause cannot be determined, however, based upon the ifu; a possible cause of this event could be using sharp and electro-surgical devices that cause the bag to rip.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 three (3) devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 43 reports, regarding 47 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.(b)(4).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.
Event or Problem Description
A customer reported that the device, trs-robo-8, anchor tissue retrieval system, was used in a robot/lap chole procedure on (b)(6) 2025 and "anchor bags ripped upon exiting the patient with the specimen.No injury to the patient.¿.Further assessment found "failure of bag, seam split downside".No device fragments or portions of specimen fell into the patient.There was no contamination and no change in the wound classification, but "incision expanded to retrieve gallbladder, had to put in a fascial stitch.".The procedure was completed with a delay of "maybe 7 minutes to retrieve gallbladder and then close incision".There was "no extended stay, no long-term affect to patient".This report is being raised due to the reported injury of extended incision requiring fascial stitch.

• 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 21708315
• Report Number: 3007305485-2025-00060
• Device Sequence Number: 4682235
• Product Code: GCJ
• UDI-Device Identifier: 20653405986147
• UDI-Public: (01)20653405986147(17)270531(10)202405314
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

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: TRS-ROBO-8
• Device Lot Number: 202405314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic