inforMED
MalfunctionJOS

KNIFE ELECTRODE

Received May 4, 2017 · Event occurred Sep 9, 2016

Report 6544350 · MDR key 6544350

Device

Generic name

Electrode, Electrosurgical

Manufacturer

Richard Wolf Gmbh

Lot number

51002651

Product problems

  • Device Inoperable

Patient

73 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

DURING A TRANSURETHRAL PROSTATE RESECTION AND CYSTOLITHOLAPAXY THE DISPOSABLE ELECTRODE IN THE WORKING CONTINUOUS FLOW SCOPE WAS NOT CAUTERIZING WHEN ACTIVATED. THE KNIFE AND LOOP ELECTRODE WERE BOTH USED AND NEITHER WERE WORKING PROPERLY. THE PATIENT WAS NOT HARMED.