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

Catalog Number	TRS100SB2
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The distributor reported on behalf of their customer that the device, trs100sb2, anchor tissue retrieval system, was being used during a lap chole procedure on (b)(6) 2024 when it was reported, ¿the metal portion of the anchor bag was unable to close as the metal portion was protruding out of the anchor bag.Hence, had to use another bag.¿.Further assessment information found that the device malfunction was discovered prior to use of the device on the patient.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The distributor reported on behalf of their customer that the device, trs100sb2, anchor tissue retrieval system, was being used during a lap chole procedure on 16dec24 when it was reported, ¿the metal portion of the anchor bag was unable to close as the metal portion was protruding out of the anchor bag.Hence, had to use another bag.¿.Further assessment information found that the device malfunction was discovered prior to use of the device on the patient.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Examination of returned used device trs100sb2 found that the metal ring was poking through the top of the bag.The root cause cannot be determined, however, based upon evaluation, photos and the ifu, the likely cause of this event was excessive force that pulled the bag off of the handle arms of the device.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.This is the only complaint for this lot number and failure mode within the past two years.(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.

• 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: 21091492
• Report Number: 3007305485-2025-00001
• Device Sequence Number: 12925943
• Product Code: GCJ
• UDI-Device Identifier: 20653405986109
• UDI-Public: (01)20653405986109(17)270911(10)202409114
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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: TRS100SB2
• Device Lot Number: 202409114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• 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 Sex: Unknown
• Patient Ethnicity: Non Hispanic