MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER FORCETRIADZD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	FORCETRIADZD
Medical Device Problem Codes	Failure to Calibrate (2440); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: na/other.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during use, the device had calibration issue and wanted the unit to be tested to make sure it was functioning properly.There was patient burn on the face.

• Brand Name: FORCETRIADZD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7786634
• Report Number: 1717344-2018-01089
• Device Sequence Number: 1986222
• Product Code: GEI
• UDI-Device Identifier: 10884521129498
• UDI-Public: 10884521129498
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K110268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2018

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: FORCETRIADZD
• Device Catalogue Number: FORCETRIADZD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1