OLYMPUS HIGH FREQUENCY RESECTION ELECTRODE
Received May 24, 2010 · Event occurred Apr 23, 2010
Report 9610773-2010-00012 · MDR key 1701059
Device
Product problems
- Collimator design problem
- Detachment of Device or Device Component
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF PROSTATE (TURP) THE DISTAL TIP OF THE ELECTRODE LOOP BROKE OFF INSIDE THE PT AFTER TWENTY MINUTES OF USE. THE BROKEN PORTION OF THE LOOP WAS RETRIEVED WITH AN UNK DEVICE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT, BUT SIMILAR ELECTRODE. THERE WAS NO PT INJURY REPORTED.
Additional Manufacturer Narrative
THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE USERS REPORT, AS THE TIP OF THE ELECTRODE WAS FOUND DAMAGED AND DETACHED. THERE WAS EVIDENCE OF THERMAL DAMAGE NOTED ON BOTH ENDS OF THE LOOP PIECES, AND BIOMATERIALS ON THE SURFACE OF THE LOOP. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED. NO OTHER EQUIPMENT USED DURING THE PROCEDURE WAS RETURNED FOR EVALUATION, AS THERE WERE NO ALLEGATIONS OF MALFUNCTION ASSOCIATED WITH THE OTHER ITEMS. THE DEVICE WILL BE FORWARDED TO THE ORIGINAL EQUIPMENT MANUFACTURER FOR FURTHER EVALUATION. IF SIGNIFICANT ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.