COOK UROLOGICAL STORZ DOUBLE STEM CUTTING LOOP 24
Received Mar 16, 2010 · Event occurred Feb 1, 2010
Report MW5015196 · MDR key 1636154
Device
Generic name
Cutting Loop Electrode
Manufacturer
Omnitech Systems, Inc.Model number
CL-2414-KS2Lot number
22072
Product problems
- Material Discolored
Patient
Not reported
- Awareness during Anaesthesia
Narrative
Description of Event or Problem
AN ESU -GENERATOR- WAS USED IN CONJUNCTION WITH A KARL STORZ POWER CORD, STORZ RESECTOSCOPE, AND STORZ TELESCOPE. THE CAUTERY LOOP THAT WAS PLUGGED INTO THE STORZ RESECTOSCOPE WAS A DISPOSABLE COOK PRODUCT. DURING A TURP -TRANSURETHRAL RESECTION OF THE PROSTATE-, THE NURSE NOTED THE ANESTHETIZED PATIENT JERKED. THE NURSE NOTIFIED THE SURGEON, WHO THEN DISCONTINUED THE USE OF THE CAUTERY LOOP AND REMOVED THE RESECTOSCOPE. THE INSTRUMENTS WERE INSPECTED AND A BLACK MARK WAS NOTED ON THE TELESCOPE LENS, ALONG WITH A BLACK MARK ON THE INSULATION PART OF THE DISPOSABLE COOK CAUTERY LOOP. THE PATIENT WAS ASSESSED AND FOUND TO HAVE NO APPARENT INJURIES RELATED TO THIS EVENT.