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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A sales representative reported on behalf of a customer that the trs-robo-8, anchor tissue retrieval system device was used in a robot appendectomy procedure on approximately (b)(6) 2025, and ¿unit came apart inside of patient, no patient harm recorded possible user error¿.Further assessment found the bag did not rip."the metal jaws came off the device", completely detached and fell into the surgical site.All fragments were retrieved using robot graspers.The procedure was completed as normal without the use of an alternate device and a delay of 5 minutes.There was no report of injury, medical/surgical intervention or extended hospitalization for the patient.The patient is reportedly "fine".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the complaint investigation has not been completed.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.
Additional Manufacturer Narrative
Examination of returned used trs-robo-8 device found that the bag had completely disconnected from the string.Note that the bag was not returned and, without the bag in position with the string attached, it cannot be determined if the kickstand was in the proper position.A root cause cannot be determined; however, based upon evaluation of the device, a possible cause of this event could be that the use of excessive force.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 that 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 sales representative reported on behalf of a customer that the trs-robo-8, anchor tissue retrieval system device was used in a robot appendectomy procedure on approximately (b)(6) 2025, and ¿unit came apart inside of patient, no patient harm recorded possible user error¿.Further assessment found the bag did not rip."the metal jaws came off the device", completely detached and fell into the surgical site.All fragments were retrieved using robot graspers.The procedure was completed as normal without the use of an alternate device and a delay of 5 minutes.There was no report of injury, medical/surgical intervention or extended hospitalization for the patient.The patient is reportedly "fine".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• 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: 22871908
• Report Number: 3007305485-2025-00138
• Device Sequence Number: 5689449
• Product Code: GCJ
• UDI-Device Identifier: 20653405986147
• UDI-Public: (01)20653405986147(17)271204(10)202412044
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: 202412044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic