MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORPORATION VOYANT OPEN FUSION DEVICE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EB240

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

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 11/28/2022

Event Type  Injury  

Event Description

Patient received a conduction burn during surgery from a "applied science voyant fusion device eb240 - advanced bipolar." the vendor was present and was notified.

• Brand Name: VOYANT OPEN FUSION DEVICE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORPORATION
• MDR Report Key: 15940853
• MDR Text Key: 305164642
• Report Number: MW5113700
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EB240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ELECTRICAL SURGICAL GENERATOR.
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Sex: Female