MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT TISSUE RETREIVAL SYSTEM; SPECIMEN BAG

Model Number	TRS175SB2
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One trs175sb2 was received in opened original packaging, the reported catalog number was verified, the lot number was not verified.Visual inspection found that the specimen bag was ripped/torn along the width near the top of the bag (approximately 0.5 inches from the drawstring.The manufacturing documents of 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 with the past two years.A two-year review of complaint history revealed there has been 13 complaints, regarding 16 devices for this device family and failure mode.During the same time frame (b)(4) devices were 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; 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.The tissue retrieval system is for single patient use only and should not be re-sterilized.The ability to effectively clean and reuse this single use device has not been established and subsequent re-use may adversely affect the performance, safety and/or stability of the device.The use of morcellators within the anchor tissue retrieval system has not been evaluated.The tissue retrieval system is not recommended for use with power morcellators.Care should be taken when using sharp and electrosurgical devices.Note the size of the trocar when removing a specimen through the trocar cannula and seal system.If required, enlarge the port site to aid in the removal of the tissue retrieval system.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that (2) trs175sb2, specimen bags ripped during the extraction phase of a gyn case on (b)(6) 2018.The bag ripped while removing the tube and ovary through the abdominal incision.The surgical team is familiar with the device.Additional information was requested, however there was no new information to add.There was no patient injury and no delay reported.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: TISSUE RETREIVAL SYSTEM
• 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: 8231374
• Report Number: 3007305485-2018-00318
• Device Sequence Number: 19268928
• Product Code: GCJ
• UDI-Device Identifier: 20653405986116
• UDI-Public: (01)20653405986116(17)210911(10)201809125
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

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: 09/11/2021
• Device Model Number: TRS175SB2
• Device Catalogue Number: TRS175SB2
• Device Lot Number: 201809125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 01/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1