MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY TIS RET PROD PT SZ 25MM INTRO; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	TRS-TV-25
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	09/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified.The manufacturing documents from the device history record (dhr) have been reviewed with special attention to the manufacturing and inspection of the product.A non-conformance was found in the dhr; however, the non-conformance was not related to this event.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 3 complaints, regarding 3 devices, for this device family and failure mode.During this same time frame 483,463 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 inspect the introducer before insertion for any signs of damage, such as cracking.If any damage is noted, discard the device.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the trs-tv-25 was used during a robotic hysterectomy on approximately (b)(6) 2021 when it was reported ¿the kickstand broke off during procedure¿.There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that the component, the metal arm, that releases the bag had fallen into the patient and was retrieved with robotic graspers and placed in the bag.The procedure is reported as having been completed as planned with a 5-minute delay.The sales representative also reported that the surgeon had grabbed the arm of the device to help open the bag and that this is the possible reason for the failure.The patient has been reported as doing ¿well¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: TIS RET PROD PT SZ 25MM INTRO
• 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
• MDR Report Key: 12561097
• Report Number: 3007305485-2021-00389
• Device Sequence Number: 1547512
• Product Code: GCJ
• UDI-Device Identifier: 20653405986178
• UDI-Public: (01)20653405986178(17)240415(10)202104164
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/01/2021

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: 04/15/2024
• Device Model Number: TRS-TV-25
• Device Catalogue Number: TRS-TV-25
• Device Lot Number: 202104164
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 10/01/2021
• Patient Sequence Number: 1