inforMED
MalfunctionFAS

N.A.

Received Jun 15, 2026 · Event occurred Jun 7, 2026

Report 25501493 · MDR key 25501493

Device

Generic name

Electrode, Electrosurgical, Active, Urological

Model number

27040GP130-S

Catalog number

27040GP130-S

Lot number

43LE4523

Patient

66 YR · Male

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

FROM STAFF: WE WERE DOING A CLOT EVACUATION/BLADDER TUMOR RESECTION CASE WITH THE STORZ RESECTOSCOPE USING THE BIPOLAR LOOP. NORMAL PRE-SET SETTINGS WERE USED DURING THE CASE. WHILE BEING USED, THERE WAS A SUDDEN POP, SPARK AND CLOUD OF SMOKE THAT CAME FROM THE CORD OF THE SCOPE. SCOPE WAS PULLED OUT AND TAKEN OFF THE FIELD, PIECES SET ASIDE TO BE EVALUATED BY RISK. THERE WAS NO NOTED HARM TO THE PATIENT. DURING SET UP, THE CORD WAS NOT NOTED TO HAVE ANY IMPERFECTIONS, HOWEVER UPON INSPECTION AFTER THE EVENT TOOK PLACE, IT APPEARS ONE WIRE IS STICKING OUT OF THE CORD AND NOT COATED.