MalfunctionFGM
4.5 FR DISPOSABLE ELECTROHYDRAULIC
Received Jan 6, 1998 · Event occurred Dec 9, 1997
Report MW1012745 · MDR key 141785
Device
Generic name
Lithotriptor Probe
Manufacturer
Karl Star Endoscopy-americaModel number
*Catalog number
27080EA
Lot number
8042
Product problems
- Dislodged
Patient
48 YR
- Surgery, prolonged
Narrative
Description of Event or Problem
PT ADMITTED FOR CYSTOURETHROSCOPY (STONE REMOVAL). STONE WAS 9-10MM. ATTEMPTED A #3 FRENCH EHL PROBE BUT FOR SOME REASON IT WAS FUNCTIONING POORLY AND THE PROBE WOULD NOT WORK. ATTEMPTED TO INTRODUCE A 4.5 FRENCH EHL PROBE AND IT DID WORK. IT WAS FILING AND CHIPPING ON THE STONE WHEN THE TIP DISLODGED FROM THE TOP OF THE PROBE, THE METAL PORTION, AND STAYED ALONG THE SIDE OF THE STONE. THE TIP OF THE STONE WAS REMOVED.