MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY ANCR TISSUE RETRIEVAL SYSTEM, 15MM, 1800ML (3/BX); LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	TRS190SB2
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
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.We will continue to monitor for trends through the complaint system to assure patient safety.Device not yet received.
Event or Problem Description
The customer reported that the device, trs190sb2, ancr tissue retrieval system, 15mm, 1800ml, was being used during abdominal surgery procedure on (b)(6) 2023 when it was reported ¿surgeon was trying to get the specimen in the bag and while doing so the forcep went through the bag and punctured the colon.Surgeon stated there was a large tear in the bag.It is unknown if it was torn prior to deployment.Repair suture of punctured colon/bowel.¿.It was also reported that the ¿procedure was successful¿.The procedure was completed with the use of the same alternate device, and the current status of the patient was reported as ¿good¿.There was no report of extended hospitalization to patient or user.This report is being raised on the reported injury due the patient¿s colon being punctured.
Event or Problem Description
The customer reported that the device, trs190sb2, ancr tissue retrieval system, 15mm, 1800ml, was being used during abdominal surgery procedure on (b)(6) 2023 when it was reported ¿surgeon was trying to get the specimen in the bag and while doing so the forcep went through the bag and punctured the colon.Surgeon stated there was a large tear in the bag.It is unknown if it was torn prior to deployment.Repair suture of punctured colon/bowel.¿.It was also reported that the ¿procedure was successful¿.The procedure was completed with the use of the same alternate device, and the current status of the patient was reported as ¿good¿.There was no report of extended hospitalization to patient or user.This report is being raised on the reported injury due the patient¿s colon being punctured.
Additional Manufacturer Narrative
Received one trs190sb2 in opened original package.Lot number was verified.Performed a visual inspection, the retrieval bag was detached from the device.No visual tears were confirmed within the device.Although the bag did not have a ¿large tear¿, the bag was detached from the prongs.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 2 complaints, regarding 2 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 that care should be taken when using sharp and electro-surgical devices.Note the size of the trocar cannula when removing a specimen through the trocar cannula and seal system.If required, enlarge the port site to aid removal of the anchor¿ tissue retrieval system¿ by conmed.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: ANCR TISSUE RETRIEVAL SYSTEM, 15MM, 1800ML (3/BX)
• 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
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 17059108
• Report Number: 3007305485-2023-00140
• Device Sequence Number: 12023029
• Product Code: GCJ
• UDI-Device Identifier: 20653405986130
• UDI-Public: (01)20653405986130(17)250411(10)202204124
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2025
• Device Catalogue Number: TRS190SB2
• Device Lot Number: 202204124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic