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

Model Number	FORCEFXC
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Arcing (2583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Electric Shock (2554)
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 a procedure when opening up a pocket for an implant, the unit had arcing/sparking wherein the scrubs and sterile scrubs was burnt and hit the physician in the upper abdomen.Also, the unit shocked the physician and had to sit down after the shock since it knocked the breath out of doctor and had staggered back and needed a few moments to catch his breath.

• Brand Name: FORCE FX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 14069414
• Report Number: 1717344-2022-00407
• Device Sequence Number: 6172243
• Product Code: GEI
• UDI-Device Identifier: 10884524002613
• UDI-Public: 10884524002613
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2022

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: FORCEFXC
• Device Catalogue Number: FORCEFXC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/10/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male