MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY ANCR TISSUE RETRIEVAL SYSTEM, 15MM, 1200ML (3/BX); LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number TRS175SB2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888)

Event Date 01/23/2023

Event Type  Death  

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

Conmed japan reported on behalf of a customer that the trs175sb2, ancr tissue retrieval system, 15mm, 1200ml (3/bx) device was being used on (b)(6) 2023, and ¿during thoracoscopic surgery, bleeding was observed, so a thoracotomy was performed, the bleeding site was confirmed to be proximal to the main trunk of the left pulmonary artery, and an attempt was made to stop the bleeding, but cardiac arrest occurred.The bleeding was controlled through intrathoracic cardiac massage, but the bleeding could not be stopped and the patient died.¿.Further assessment found that the device ¿had contact with the patient during the bleeding event, which resulted in significant bleeding shortly after." it is unknown what specimen was intended to be retrieved or if tissue retrieval was successful.The device was deployed at the time of the event and did not fracture.The device functioned as intended and "no functional defects in structure or materials were found".This report is raised on the basis of the reported death of a patient.

Manufacturer Narrative

The assessment of the device did not indicate any issue with the functionality of the device.The device will not be returned, and no photographic evidence was provided.Therefore, the reported event cannot be verified.A two-year lot history review cannot be conducted as a lot number was not provided.A device history record (dhr) review cannot be conducted as a lot number was not provided.A two-year review of complaint history revealed there has been a total of (b)(4) reports, regarding (b)(4) 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 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.Do not use the anchor¿ tissue retrieval system¿ if resistance is met upon deployment.Improper use of the anchor¿ tissue retrieval system¿ may result in perforation of tissue and subsequent bleeding.Care should be taken when using sharp and electro-surgical devices.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

Conmed japan reported on behalf of a customer that the trs175sb2, ancr tissue retrieval system, 15mm, 1200ml (3/bx) device was being used on (b)(6) 2023, and ¿during thoracoscopic surgery, bleeding was observed, so a thoracotomy was performed, the bleeding site was confirmed to be proximal to the main trunk of the left pulmonary artery, and an attempt was made to stop the bleeding, but cardiac arrest occurred.The bleeding was controlled through intrathoracic cardiac massage, but the bleeding could not be stopped and the patient died.¿.Further assessment found that the device ¿had contact with the patient during the bleeding event, which resulted in significant bleeding shortly after." it is unknown what specimen was intended to be retrieved or if tissue retrieval was successful.The device was deployed at the time of the event and did not fracture.The device functioned as intended and "no functional defects in structure or materials were found".This report is raised on the basis of the reported death of a patient.

Manufacturer Narrative

Update to investigation summary: received one trs175sb2 in unoriginal packaging.One the retrieval bag was returned.Lot number was not verified.Performed a visual inspection, there were no obvious signs of abnormalities or defects.A two-year lot history review cannot be conducted as a lot number was not provided.A device history record (dhr) review cannot be conducted as a lot number was not provided.A two-year review of complaint history revealed there has been a total of two reports, regarding two devices, for this device family and failure mode.(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.Do not use the anchor¿ tissue retrieval system¿ if resistance is met upon deployment.Improper use of the anchor¿ tissue retrieval system¿ may result in perforation of tissue and subsequent bleeding.Care should be taken when using sharp and electro-surgical devices.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

Conmed japan reported on behalf of a customer that the trs175sb2, ancr tissue retrieval system, 15mm, 1200ml (3/bx) device was being used on 23jan23, and "during thoracoscopic surgery, bleeding was observed, so a thoracotomy was performed, the bleeding site was confirmed to be proximal to the main trunk of the left pulmonary artery, and an attempt was made to stop the bleeding, but cardiac arrest occurred.The bleeding was controlled through intrathoracic cardiac massage, but the bleeding could not be stopped and the patient died." further assessment found that the device "had contact with the patient during the bleeding event, which resulted in significant bleeding shortly after." it is unknown what specimen was intended to be retrieved or if tissue retrieval was successful.The device was deployed at the time of the event and did not fracture.The device functioned as intended and "no functional defects in structure or materials were found." this report is raised on the basis of the reported death of a patient.

• Brand Name: ANCR TISSUE RETRIEVAL SYSTEM, 15MM, 1200ML (3/BX)
• Type of Device: 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 18894634
• MDR Text Key: 337553563
• Report Number: 3007305485-2024-00037
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: TRS175SB2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Ethnicity: Non Hispanic