MAUDE Adverse Event Report: CONMED CORPORATION ABC BEND-A-BEAM; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	134003
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During a cholecystectomy and liver resection, the surgeon asked for the argon beam to be in the room for use during the procedure.The patient was plated on his left thigh area.The area was clean dry and intact.The rn plugged the argon beam in and the scrub tech purged the device per protocol.The physician began to use the argon beam and the headpiece started to catch fire.The physician was able to extinguish the flame.No harm came to the patient or to staff.The argon generator was removed from service and inspected by biomed with normal outputs and perceivable issues.The hand piece was also saved and images were collected and attached.At this time it is unclear whether the equipment/hand piece could have caused or contributed to this event.The hand piece has been returned for failure analysis.Manufacturer response for electrosurgical, cutting coagulation accessories, abc bend-a-beam, (per site reporter).The device was returned for failure analysis.No report has been received yet.

• Brand Name: ABC BEND-A-BEAM
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd; utica NY 13502
• MDR Report Key: 8956018
• Report Number: 8956018
• Device Sequence Number: 19371003
• Product Code: GEI
• UDI-Device Identifier: 10653405002741
• UDI-Public: (01)10653405002741
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2019
• Report Date (Section F): 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 134003
• Device Catalogue Number: 134003
• Device Lot Number: 201901254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 111
• Date Report Sent to FDA: 06/04/2019