MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT TIS RET SYS 15MM, 1200ML(3/BX); LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	TRS175SB2
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The alleged "popped" trs175sb2 is not expected to be returned for evaluation and review.This complaint of "popped" device is unable to be verified and a root cause cannot be determined.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 28 complaints, regarding 33 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 the following: warnings: only physicians trained in the techniques of laparoscopic or minimally invasive surgery and the use of retrieval bags to remove tissue should use this product.Precautions: care should be taken when using sharp and electro-surgical devices.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, trs175sb2, was being used during a robotic lobectomy on (b)(6) 2020 when the bag popped during the case.The doctors concern was that when the bag pops cancel cells can be spread.The procedure was completed without any report of delay.There was no report of injury to patient or user.Further assessment information was requested; however, the reporter declined to answer the assessment questions.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: TIS RET SYS 15MM, 1200ML(3/BX)
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 9836852
• Report Number: 3007305485-2020-00109
• Device Sequence Number: 2886431
• Product Code: GCJ
• UDI-Device Identifier: 20653405986116
• UDI-Public: (01)20653405986116(17)220318(10)201903194
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2020

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: 03/18/2022
• Device Model Number: TRS175SB2
• Device Catalogue Number: TRS175SB2
• Device Lot Number: 201903194
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/16/2020
• Patient Sequence Number: 1