MAUDE Adverse Event Report: CONMED LARGO HELIXAR ESU; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 60-8800-001

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

Patient Problems Pulmonary Embolism (1498); Cardiac Arrest (1762)

Event Type  Death  

Event Description

In an article published online on 28apr20, titled, a probable fatal argon gas embolism during resection of a cutaneous biliary fistula: a case report, regarding the helixar esu, which was being used during a resection of cutaneous biliary fistula procedure and was reported as being, ¿involved in a suspected in an argon induced embolism which ultimately involved the patient passing away 4 days later.¿ it is unknown if this case has been reported to conmed previously.¿shortly after initial use of the abc, the patient underwent cardiac arrest¿¿.This patient most likely experienced an argon gas embolism during an open resection of a cutaneous biliary fistula with possible transpulmonary passage of the embolism.Intra-operative diagnosis was a pulmonary embolism, given the patient's cancer history after a pneumothorax had been ruled out.However, event occurrence within minutes after the first use of the abc leads to the suspicion of an argon gas embolism.The air seen in the left ventricle on tee was thought to have been caused by air entering the open vasculature during chest compressions, but it might have been evidence of transpulmonary passage of the embolism.The article does not indicate a malfunction of the device.This report is being raised due to the reported death of a patient from an embolism.

Manufacturer Narrative

The device will not be returned and no photographic evidence has been provided however, an article was provided that captured the details regarding this specific event.The article states ¿this patient most likely experienced an argon gas embolism during an open resection of a cutaneous biliary fistula with possible transpulmonary passage of the embolism.Intra-operative diagnosis was a pulmonary embolism, given the patient's cancer history after a pneumothorax had been ruled out.However, event occurrence within minutes after the first use of the abc leads to the suspicion of an argon gas embolism.The air seen in the left ventricle on tee was thought to have been caused by air entering the open vasculature during chest compressions, but it might have been evidence of transpulmonary passage of the embolism¿.The likely cause of this issue is due to higher than recommended gas flow, and/ or lack of probe tip positioning and/ or altered biliary and hepatic anatomy from previous surgeries, which may have increased the patient¿s susceptibility to an embolism.The service history could not be reviewed as a serial number was not provided.A device history record review could not be conducted as a serial number was not provided.(b)(4).Per the owner's manuel, the user is advised the following: keep the probe tip at least 3 mm (0.12 in) away from the tissue, or per accessory instructions, and at a 45-60° angle during argon beam coagulation.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: HELIXAR ESU
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 18119011
• MDR Text Key: 327916392
• Report Number: 1017294-2023-00104
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K172671
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 60-8800-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention; Other
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic