inforMED
MalfunctionLNK

LASER PERIPHERAL

Received May 23, 2013 · Event occurred Apr 23, 2013

Report MW5030328 · MDR key 3136706

Device

Generic name

Laser Fiber

Manufacturer

Laser Peripherals

Catalog number

RBLF-200

Lot number

LP-200

Product problems

  • Break
  • Detachment Of Device Component
  • Difficult to Remove

Patient

30 YR

  • Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

THE PT WAS ADMITTED TO THE HOSP TO UNDERGO CYSTOSCOPY, RIGHT RETROGRADE PYELOGRAM, RIGHT URETEROSCOPIC LASER LITHOTRIPSY AND PLACEMENT OF A RIGHT URETERAL STENT. DURING THE LASER LITHOTRIPSY, A VERY SMALL PIECE (200 MICRON) OF LASER FIBER TIP BROKE OFF INTO THE RIGHT RENAL PELVIS. SEVERAL BASKET ATTEMPTS WERE MADE TO RETRIEVE THE LASER FRAGMENT, BUT THEY WERE UNSUCCESSFUL. THE OTHER PROCEDURES WERE COMPLETED UNEVENTFULLY AND THE PT WAS DISCHARGED WITH A GOOD PROGNOSIS. THE PHYSICIAN FELT THAT THIS FRAGMENT PIECE SHOULD POSE NO FUTURE HARM TO THE PT AND MAY BE ABLE TO PASS ON ITS OWN. THE PT RETURNED FOR F/U 2 WEEKS AFTER THE PROCEDURE AND WAS DOING WELL.