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

Catalog Number	TRS100SB2
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	10/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that the trs100sb2, anchor tissue retrieval system device was being used in a lap appy procedure on (b)(6) 2024, and "the bag breaks".The procedure was completed without the use of an alternate device and with a delay of 5 minutes.Further assessment found that the "bag detached from device improperly" while inside the surgical site.The bag did not fragment; the specimen did not fall out of the bag, and was ¿pulled out¿.There was no injury, medical/surgical intervention or extended hospitalization required for the patient, and the patient's current status is "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 for trends through the complaint system to assure patient safety.
Additional Manufacturer Narrative
Received one trs100sb2 in unoriginal packaging.Lot number was not verified.Performed a visual inspection, the shaft is bent at the tip.The retrieval bag was not returned with the device.Root cause cannot be determined, however, based upon evaluation of the device and ifu; a possible cause of this event could be 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 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.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
A customer reported that the trs100sb2, anchor tissue retrieval system device was being used in a lap appy procedure on (b)(6) 2024, and "the bag breaks".The procedure was completed without the use of an alternate device and with a delay of 5 minutes.Further assessment found that the "bag detached from device improperly" while inside the surgical site.The bag did not fragment; the specimen did not fall out of the bag, and was ¿pulled out¿.There was no injury, medical/surgical intervention or extended hospitalization required for the patient, and the patient's current status is "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: 20556322
• Report Number: 3007305485-2024-00160
• Device Sequence Number: 8979501
• Product Code: GCJ
• UDI-Device Identifier: 20653405986109
• UDI-Public: (01)20653405986109(17)270809(10)202408094
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: 202408094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic