inforMED
MalfunctionFAR

VALLEYLAB FORCE

Received Dec 13, 2013 · Event occurred Aug 19, 2013

Report 3890035 · MDR key 3890035

Device

Generic name

Unit, Electrosurgical

Manufacturer

Covidien

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Device Displays Incorrect Message
  • Device Operates Differently Than Expected

Patient

30 YR

  • Burn(s)

Narrative

Description of Event or Problem

AT END OF SURGERY, CIRCULATOR NOTICED A NEARLY DIME SIZED RED RAW ARE ABOVE THE MIDLINE OF THE CEAREAN SECTION INCISION. WHEN SURGEON ASKED WHAT CAUSED THE INJURY HE STATED" THAT IS WAS A BURN FROM THE MALFUNCTIONING BOVIE." AT THE START OF THE PROCEDURE THE BOVIE MALFUCTIONED AND WENT INTO AN ERROR MODE. BOVIE UNPLUGGED AND RESTARTED AND IT READ ERROR AGAIN. WHEN SURGEON TRIED TO USE IT, ONCE AGAIN IT DID THE SAME MALFUNCTION. NEW BOVIE OBTAINED FOR SURGERY AND MALFUNCTIONING BOVIE REMOVED FROM ROOM BY BIOMED. DEVICE TESTED BY BIOMED, NO PROBLEMS FOUND, ALL REQUIRED TESTS ARE WITHIN NORMAL OPERATING PARAMETERS, RETURNED TO SERVICE.