MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT TISSUE RETRIEVAL SYSTEM 15MM, 120ML; SPECIMEN BAG

Model Number	TRS175SB2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received one trs175sb2 in opened original packaging.Lot number was verified.Performed a visual inspection, the metal piece that holds the bag on was received disconnected with the pin still inside of the hole.All pieces of the device were returned.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 were 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.(b)(4).Per the instructions for use, the user is advised the following; 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.Conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the trs175sb2, anchor tissue retrieval system was used in a procedure on (b)(6) 2020.When they were pulling the bag out, they saw metal and the purple sleeve.There was a loose piece of metal that came out of the tube.The customer would like the device to be evaluated to be sure nothing was left in the patient.There is no reported known patient injury or impact.There is no reported delay of procedure.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: TISSUE RETRIEVAL SYSTEM 15MM, 120ML
• Common Device Name: SPECIMEN BAG
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 9769548
• Report Number: 3007305485-2020-00057
• Device Sequence Number: 11308921
• Product Code: GCJ
• UDI-Device Identifier: 20653405986116
• UDI-Public: (01)20653405986116(17)220807(10)201908084
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2020

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: 08/07/2022
• Device Model Number: TRS175SB2
• Device Catalogue Number: TRS175SB2
• Device Lot Number: 201908084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1