MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY ANCR TISSUE RETRIEVAL SYSTEM, 8MM, 125ML (5/BX); LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	TRS-ROBO-8
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.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.
Event or Problem Description
A sales representative reported on behalf of his customer that the trs-robo-8, ancr tissue retrieval system, 8mm, 125ml (5/bx) was being used during a surgical procedure for a right anterior mediastinal mass with thymectomy on (b)(6) 2023 and ¿had two 8mm anchor bags rip while extracting a mass from the patient.¿ further assessment confirmed that "the bag did not fragment off and didn't not have any pieces or components fall into the patient".The procedure was completed with a reported 20-minute delay, using ¿our 12mm anchor bag¿ as an alternate device.There was no report of injury, medical intervention, or prolonged hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
A sales representative reported on behalf of his customer that the trs-robo-8, ancr tissue retrieval system, 8mm, 125ml (5/bx) was being used during a surgical procedure for a right anterior mediastinal mass with thymectomy on (b)(6) 2023 and ¿had two 8mm anchor bags rip while extracting a mass from the patient.¿ further assessment confirmed that "the bag did not fragment off and didn't not have any pieces or components fall into the patient".The procedure was completed with a reported 20-minute delay, using ¿our 12mm anchor bag¿ as an alternate device.There was no report of injury, medical intervention, or prolonged hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
This device was not returned for evaluation; however, photographic evidence confirmed the reported event of ¿bag breaking¿.The root cause cannot be determined, however, based upon the photos and the instructions for use, the likely cause of this event was that the port site was not large enough to remove the mass.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 two-year lot history review shows that this is the only device for this lot number and failure mode.(b)(4).Per the instructions for use, the user is advised to: ¿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 for trends through the complaint system to assure patient safety.

• Brand Name: ANCR TISSUE RETRIEVAL SYSTEM, 8MM, 125ML (5/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: 17767291
• Report Number: 3007305485-2023-00206
• Device Sequence Number: 12554053
• Product Code: GCJ
• UDI-Device Identifier: 20653405986147
• UDI-Public: (01)20653405986147(17)260618(10)202306195
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

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: 06/18/2026
• Device Catalogue Number: TRS-ROBO-8
• Device Lot Number: 202306195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2023
• 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 Age: 33 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic