inforMED
MalfunctionHAM

KIRWAN

Received May 3, 2023 · Event occurred Apr 12, 2023

Report 16860048 · MDR key 16860048

Device

Generic name

Apparatus, Electrosurgical

Model number

30-5201

Catalog number

30-5201

Lot number

221018

Product problems

  • Break
  • Material Erosion
  • Energy Output Problem
  • Protective Measures Problem

Patient

1825 DA · Male

  • Superficial (First Degree) Burn
  • Superficial (First Degree) Burn

Narrative

Description of Event or Problem

FROM OPERATIVE REPORT: DUE TO EXTENSIVE ADENOID TISSUE I DID RELEASE THE MOUTH GAG TO ALLOW FOR REPERFUSION OF THE TONGUE. I NOTICED AT THIS POINT THAT THE SUCTION CAUTERY WAS BROKEN AT THE BASE OF THE FLEXIBLE COMPONENT WHERE IT ATTACHES TO THE HANDLE. I REMOVED IT OFF THE FIELD AND IT WAS AT THIS POINT, I NOTICED A CAUSTIC INJURY OF THE RIGHT ANTERIOR ORAL TONGUE AND THE RIGHT INFERIOR MUCOSAL LIP. THE ANTERIOR COMMISSURE WAS SPARED. AT NO POINT DID THE TIP OF THE SUCTION MONOPOLAR CAUTERY CAUTERIZE THESE TISSUES. I THEN INSPECTED THE SUCTION MONOPOLAR CAUTERY DEVICE ITSELF AND NOTICED THAT A PORTION OF THE BLUE INSULATION HAD BEEN ERODED WITH EXPOSED METAL. I ASSUME THAT THIS WAS THE CAUSE OF THE CAUSTIC INJURIES AS LISTED ABOVE. THIS PORTION OF THE SUCTION CAUTERY WAS NOT VISIBLE TO ME WHILE I WAS PERFORMING THE ADENOIDECTOMY. I THEN SWITCHED OVER TO A PREVIOUS MODEL OF SUCTION MONOPOLAR CAUTERY, THE WHITE AND BLUE ONE WITH A LARGER LUMEN, TO COMPLETE THE ADENOIDECTOMY. THE ORIGINAL SUCTION MONOPOLAR CAUTERY DEVICE WAS PASSED OFF FOR INSPECTION AND DOCUMENTATION. FROM STAFF: WHILE DOING A T&A THE SUCTION COAGULATOR BROKE AT THE PART IT CONNECTS TO THE HANDPIECE, WHICH THEN CAUSED THE INSULATION TO BREAK DOWN ON THE COAGULATOR AND THE PATIENT'S TONGUE WAS BURNED ON THE RIGHT SIDE. WE WERE USING A SUBSTITUTE COAGULATOR AS OUR NORMAL ONES HAVE BEEN ON BACK ORDER. THE COAGULATOR BEING USED WAS THE FOOT-CONTROLLED KIRWAN SURGICAL MONOPOLAR COAGULATOR 8 INCH. A NEW AND DIFFERENT COAGULATOR WAS OPENED TO THE FIELD. DR. PLACED 3 CHROMIC SUTURES ON THE WOUNDED AREA.