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

Model Number	134006
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Per the attending surgeon, the handpiece began "shooting flames" and a new handpiece needed to be used.

• Brand Name: ABC BEND-A-BEAM
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 6455 s yosemite st ste 1000; greenwood village CO 80111
• MDR Report Key: 7913683
• Report Number: 7913683
• Device Sequence Number: 16728957
• Product Code: GEI
• UDI-Device Identifier: 00653405002751
• UDI-Public: (01)00653405002751(17)230121(10)201801224
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/21/2018
• Report Date (Section F): 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 134006
• Device Catalogue Number: 134006
• Device Lot Number: 201801224
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 67
• Date Report Sent to FDA: 09/21/2018