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

Model Number FORCEFXC

Device Problems Arcing (2583); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problem Burn(s) (1757)

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the unit was making loud noise, arced and caused burn to the doctor.

• Brand Name: FORCE FX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 9673340
• MDR Text Key: 178122185
• Report Number: 1717344-2020-00117
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884524002613
• UDI-Public: 10884524002613
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FORCEFXC
• Device Catalogue Number: FORCEFXC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2020
• Date Device Manufactured: 07/30/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1