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

Catalog Number	TRS175SB2
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, trs175sb2, anchor tissue retrieval system, was being used during a laparoscopic procedure on (b)(6) 2025 when it was reported, ¿small metal piece fell into patient, once bag deployed - difficulty inserting trocar into mis port and in manipulating white handle.¿ there was no report of injury, medical intervention, or hospitalization for the patient or user.The procedure was completed as planned, using an unknown alternate device.Further assessment was requested to determine if the piece was removed from the patient; however, to date no response has been received from the reporter.This report is being raised due to the reported injury of possible retained foreign body in patient.
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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 2 complaints, regarding 2 devices, for this device family and failure mode.During this same time frame (b)(4) 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 (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.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 sales representative reported on behalf of the customer that the device, trs175sb2, anchor tissue retrieval system, was being used during a laparoscopic procedure on (b)(6) 2025 when it was reported, ¿small metal piece fell into patient, once bag deployed - difficulty inserting trocar into mis port and in manipulating white handle.¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.The procedure was completed as planned, using an unknown alternate device.Further assessment was requested to determine if the piece was removed from the patient; however, to date no response has been received from the reporter.This report is being raised due to the reported injury of possible retained foreign body in patient.

• 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: 22103835
• Report Number: 3007305485-2025-00092
• Device Sequence Number: 12601648
• Product Code: GCJ
• UDI-Device Identifier: 20653405986116
• UDI-Public: (01)20653405986116(17)270909(10)202409094
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K172940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: TRS175SB2
• Device Lot Number: 202409094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic