MalfunctionLNK
BOSTON SCIENTIFIC
Received Jun 10, 2010 · Event occurred May 26, 2010
Report MW5016335 · MDR key 1724935
Device
Product problems
- Defective Component
- Device Contamination with Chemical or Other Material
Patient
88 YR
- No Information
Narrative
Description of Event or Problem
PT COMPLAINED OF PROSTATITIS & URINARY RETENTION. PT HAVING A LASER TUR DONE USING LASER FIBERS THROUGH A LASER CYSTOSCOPE. USING 80 WATTS THE BLADDER NECK AND MEDIAN BAR WAS LASED. USING 100 WATTS THE LATERAL LOBES WERE THEN LASED. THE FIRST TWO FIBERS WERE DEFECTIVE AND APPROPRIATE THERAPY WAS NOT COMPLETED UNTIL THE THIRD FIBER WAS USED (FROM A DIFFERENT LOT). BLACK SEDIMENT AND SPOTS OF BLACK METALLIC NOTED WITH THE DEFECTIVE FIBERS. THE HOLMIUM LASER WAS BEING USED.