MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY TISSUE RETRIEVAL SYSTEM, BAG-ALONE, 10MM, 175ML; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	TRS070
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation and no photographic evidence has been provided; therefore, the reported event cannot be verified.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 one complaint, regarding one device, 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 that it is not advised to pull the anchor bag-alone tissue retrieval system by conmed containing a specimen through a trocar cannula.If required, enlarge the port site to aid removal of the anchor bag-alone tissue retrieval system by conmed.This issue will continue to be monitored through the complaint system to assure patient safety.Note: this report is being resubmitted following an unsuccessful submission attempt on 17aug21 due to a system error.
Event or Problem Description
The customer reported that the device, trs070, was being used during a laparoscopic cholecystectomy on approximately (b)(6) 2021 when it was reported we have had an issue in theatres with one of these retrieval bags.Whilst trying to remove the bag from a patients abdomen via the umbilical port during a laparoscopic cholecystectomy, the bag split.The result of then led to a gallstone falling back into the abdomen and the gallbladder histological specimen becoming at risk of being retained.On inspection of the bag, it seemed like the material had frayed then split.The procedure was reported as being completed with no delay and no injury, medical intervention, or hospitalization of the patient.Further assessment information was requested; however, to date we have not received an answer.There was no report of any component or fragment of the device coming loose or being retained in the patient and the specimen was removed as the reporter states the specimen was at risk of being retained, not that it was retained.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: TISSUE RETRIEVAL SYSTEM, BAG-ALONE, 10MM, 175ML
• 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: 12386191
• Report Number: 3007305485-2021-00345
• Device Sequence Number: 11985017
• Product Code: GCJ
• UDI-Device Identifier: 20653405986079
• UDI-Public: (01)20653405986079(17)240329(10)202103304
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K183600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2021

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: 03/29/2024
• Device Model Number: TRS070
• Device Catalogue Number: TRS070
• Device Lot Number: 202103304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1