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

Catalog Number	TRS100SB2
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
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 trs100sb2, anchor tissue retrieval system was being used on (b)(6) 2025 during a lap chole and ¿the metal deployment failed to release properly, and the metal prongs came through the bag inside the patient and the entire device/bag/specimen had to be removed from the patient together in order to release it.We needed to go back in laparoscopically after this deployed wrong.¿ per further assessment it was reported ".They were not able to finish the procedure as planned and needed to return the camera and tools back into the patient laparoscopically to fix the bag issue, ensure there was no adverse impact to the patient, and to safely remove the bag, deployment mechanism, and specimen from the patient before finishing.As such i don't believe a new surgical intervention was required but rather an extension of the laparoscopic procedure." there was no impact or injury to the patient or user and the patient was reported as ¿no apparent harm¿.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The sales representative reported on behalf of the customer that the trs100sb2, anchor tissue retrieval system was being used on 12mar25 during a lap chole and ¿the metal deployment failed to release properly, and the metal prongs came through the bag inside the patient and the entire device/bag/specimen had to be removed from the patient together in order to release it.We needed to go back in laparoscopically after this deployed wrong.¿ per further assessment it was reported ".They were not able to finish the procedure as planned and needed to return the camera and tools back into the patient laparoscopically to fix the bag issue, ensure there was no adverse impact to the patient, and to safely remove the bag, deployment mechanism, and specimen from the patient before finishing.As such i don't believe a new surgical intervention was required but rather an extension of the laparoscopic procedure." there was no impact or injury to the patient or user and the patient was reported as ¿no apparent harm¿.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device has not been returned to date and no photographic evidence was provided.Therefore, the reported event can not be verified.If the device is returned at a later date, the investigation may be updated and reanalyzed.Root cause cannot be determined, however, based upon the ifu; a possible cause of this event could be excessive force when resistance was met.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 the following: do 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
The sales representative reported on behalf of the customer that the trs100sb2, anchor tissue retrieval system was being used on 12mar25 during a lap chole and ¿the metal deployment failed to release properly, and the metal prongs came through the bag inside the patient and the entire device/bag/specimen had to be removed from the patient together in order to release it.We needed to go back in laparoscopically after this deployed wrong.¿ per further assessment it was reported ".They were not able to finish the procedure as planned and needed to return the camera and tools back into the patient laparoscopically to fix the bag issue, ensure there was no adverse impact to the patient, and to safely remove the bag, deployment mechanism, and specimen from the patient before finishing.As such i don't believe a new surgical intervention was required but rather an extension of the laparoscopic procedure." there was no impact or injury to the patient or user and the patient was reported as ¿no apparent harm¿.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Update: examination of the returned used device trs100sb2 found that it was able to release properly.However, the prongs were bent and sticking out of the bag when it was released.The bent prongs could have been from excessive force when the customer was trying to release the bag the first time.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 8 reports, regarding 8 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 the following: do 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 22001562
• Report Number: 3007305485-2025-00086
• Device Sequence Number: 7238379
• Product Code: GCJ
• UDI-Device Identifier: 20653405986109
• UDI-Public: (01)20653405986109(17)270904(10)202409044
• 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,Followup
• Report Date (Section B): 07/24/2025

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: 202409044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 06/25/2025; 07/18/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/26/2025; 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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