MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY TRS, VATS, 15MM (3/BX); LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	TRS-VATS-15
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported event is inconclusive.The device will not be returned for evaluation and no photographic evidence has been 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 10 reports, regarding 22 devices, for this device family and failure mode.During this same time frame 533,016 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 0.00004.Per the instructions for use, the user is advised the following: care should be taken when using sharp and electro-surgical devices.The range of anchor¿ tissue retrieval system¿ by conmed are contraindicated when, in the judgement of the doctor or physicians, the use of such a system would not be in the best interest of the patient.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, trs-vats-15, trs, vats, 15mm (3/bx)10ft was being used on (b)(6) 2022 during a right lower lung lobectomy procedure and ¿during retrieval surgery, bag busted on patient.No patient injury.Procedure completed successfully with another bag.Busted bag was discarded ¿.There was no injury to the patient or user reported.There was also no report of medical intervention or hospitalization for this event.The procedure was completed with an alternate bag and there was no delay to the procedure.Further assessment information found that the bag did not break into pieces, it split in half.The bag was retrieved with forceps.The specimen was in the bag, and it fell into patient.Both the specimen and bag were retrieved.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: TRS, VATS, 15MM (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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 14072800
• Report Number: 3007305485-2022-00044
• Device Sequence Number: 5938599
• Product Code: GCJ
• UDI-Device Identifier: 20653405986161
• UDI-Public: (01)20653405986161(17)240725(10)202107265
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2022

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: 07/25/2024
• Device Model Number: TRS-VATS-15
• Device Catalogue Number: TRS-VATS-15
• Device Lot Number: 202107265
• 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: 03/17/2022
• Initial Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic