inforMED
MalfunctionFFZ

CIRCON ACMI

Received Jun 26, 2001 · Event occurred Jun 12, 2001

Report MW1022270 · MDR key 339630

Device

Generic name

Cable, Cautery Accessory

Manufacturer

Ciron Acmi

Model number

RAC-B

Catalog number

*

Lot number

*

Product problems

  • Break
  • Material Frayed
  • Replace
  • Sparking

Patient

95 YR

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

DURING A SURGICAL PROCEDURE A CAUTERY ACCESSORY CABLE CLOSEST TO THE RESECTOSCOPE BEGAN TO SPARK NEAR THE PHYSICIAN'S FACE. THE CABLE WAS DISCONTINUED FROM USE IMMEDIATELY. IT WAS NOTED THAT THE CONNECTOR END FRAYED AND BROKE. THERE WAS NO FLAME OR FIRE ON DRAPES NOR INJURY TO PATIENT, STAFF OR PHYSICIAN. THE ESU UNIT WAS ALSO INSPECTED AND WAS OPERATING CORRECTLY. FOUND THAT THE GROUND ON THE POWER PLUG OF THE ESU WAS INTERMITTENTLY BAD WHEN TWISTED AND SO THE POWER CORD WAS REPLACED. THIS, HOWEVER, HAD NO EFFECT ON ACCESSORY CABLE SPARKING.