inforMED
MalfunctionFJL

MONOPOLAR 1 CABLE

Received Feb 21, 2025

Report MW5166614 · MDR key 21432606

Device

Generic name

Resectoscope

Model number

KARL STORZ 26002

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE UNIT'S MONOPOLAR 1 WAS TOAST-CABLE CAUGHT ON FIRE, AND THERE WAS A BURNT SIGNAL ON THE FRONT PART. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).