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	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2019
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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
This distributor reported on behalf of their customer that the trs175sb2 device was being used during a sleeve procedure on (b)(6) 2019 and "at the time of deployment the bag separated partially from the device but remained attached".Therefore, there was nothing to retrieve from the patient.There was no report of injury to the user or 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 packaging.Lot number was verified.Performed a visual inspection, the string was tangled up in the top of the purple shaft and the metal prongs were protruding through the specimen bag.Performed a functional inspection, when trying to deploy the bag due to the string being tangled, the bag was not expanding as intended therefore causing the metal prongs to protrude through the bag.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 30 complaints, regarding 33 devices, for this device family and failure mode.During this same time frame 511,763 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 0.00006.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 the product.-do not use the anchor tissue retrieval system if resistance is met upon deployment.Improper use of the device may result in perforation of tissue and subsequent bleeding.This issue will continue to be monitored through the complaint system to assure patient safety.

• 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: 9450142
• Report Number: 3007305485-2019-00432
• Device Sequence Number: 2606834
• Product Code: GCJ
• UDI-Device Identifier: 20653405986116
• UDI-Public: (01)20653405986116(17)220725(10)201907264
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K172940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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: 07/25/2022
• Device Model Number: TRS175SB2
• Device Catalogue Number: TRS175SB2
• Device Lot Number: 201907264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 01/16/2020
• Patient Sequence Number: 1