MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER FORCEFX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	FORCEFX
Medical Device Problem Codes	Connection Problem (2900); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during procedure, at the end of the surgery, the patient presented burns in the face after they use the monopolar/bipolar energy.There was information that the return plate was far from the surgery site, the surgery was in the cervical region and the return plate was placed on the patient's calf.

• Brand Name: FORCEFX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 12587121
• Report Number: 1717344-2021-01363
• Device Sequence Number: 1296581
• Product Code: GEI
• UDI-Device Identifier: 10884521780576
• UDI-Public: 10884521780576
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K944602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2021

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: FORCEFX
• Device Catalogue Number: FORCEFX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR