MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY ANCR TISSUE RETRIEVAL SYSTEM, 15MM, 1200ML (3/BX); LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	TRS175SB2
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	04/22/2024
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 for trends through the complaint system to assure patient safety.H3 other text : device not yet received.
Event or Problem Description
Conmed japan reported on behalf of a customer that the trs175sb2, ancr tissue retrieval system, 15mm, 1200ml (3/bx) device was being used during a video-assisted thoracoscopic surgery procedure on (b)(6) 2024, and ¿the tissue bag was detached from the support wire and it could not be opened well.¿.Further assessment found the device did not fragment, "the tissue bag just came loose from the support wire.; when the nurse received the anchor ii in the clean area and put the bag away, she noticed an unusual resistance.The doctor tried to open the bag by inserting it into the patient's body, but the wire tissue bag was not secured and came off, so they used a new product and were able to handle it without any problems.".The customer further indicated that the "tissue bag came off/detached but nothing fell into the patient's body" and all device components were retrieved.The procedure was completed with an alternate same device and no delay.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received one trs175sb2 in opened original package.Lot number was verified.Performed a visual inspection, the complaint is confirmed.The tissue bag was detached.The likely cause for this event is due to deploying the device while the distal end of the introducer remained in the trocar.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.A 2 year lot history review shows this is the only complaint for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of (b)(4) reports, regarding (b)(4) 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 to not deploy or retract the anchor¿ tissue retrieval system¿ while the distal end of introducer remains inside a trocar as it may adversely affect performance.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
Conmed japan reported on behalf of a customer that the trs175sb2, ancr tissue retrieval system, 15mm, 1200ml (3/bx) device was being used during a video-assisted thoracoscopic surgery procedure on (b)(6) 2024, and ¿the tissue bag was detached from the support wire and it could not be opened well.¿.Further assessment found the device did not fragment, "the tissue bag just came loose from the support wire.; when the nurse received the anchor ii in the clean area and put the bag away, she noticed an unusual resistance.The doctor tried to open the bag by inserting it into the patient's body, but the wire tissue bag was not secured and came off, so they used a new product and were able to handle it without any problems.".The customer further indicated that the "tissue bag came off/detached but nothing fell into the patient's body" and all device components were retrieved.The procedure was completed with an alternate same device and no delay.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: ANCR TISSUE RETRIEVAL SYSTEM, 15MM, 1200ML (3/BX)
• 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: 19354513
• Report Number: 3007305485-2024-00076
• Device Sequence Number: 7509580
• Product Code: GCJ
• UDI-Device Identifier: 20653405986116
• UDI-Public: (01)20653405986116(17)260321(10)202303225
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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 Expiration Date: 03/21/2026
• Device Catalogue Number: TRS175SB2
• Device Lot Number: 202303225
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic