FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 1590488
·
Received January 11, 2010
Report
- Report Number
- 1590488
- Event Type
- Malfunction
- Date Received
- January 11, 2010
- Date of Event
- December 29, 2009
- Report Date
- January 11, 2010
- Manufacturer
- RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
- Product Code
- FFK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CO, US
Narratives
Description of Event or Problem · 1
PATIENT UNDERGOING A PERCUTANEOUS LEFT NEPHROLITHOTOMY WHEN THE PERCUTANEOUS PROBE THE UROLOGIST WAS USING APPEARED TO BE HAVING "SHAVINGS" COMING OFF THE END. THIS PERCUTANEOUS PROBE DELIVERS HIGH FREQUENCY VIBRATIONS WHICH ARE USED TO BREAK UP ANY CALCIFICATIONS IN THE PATIENTS KIDNEY. THE PROBE WAS IMMEDIATELY RETRACTED FROM THE PATIENT AND ANOTHER ONE WAS ACQUIRED FOR USE. MD DID NOT BELIEVE THESE SHAVINGS TO BE METAL BUT WAS UNCERTAIN WHAT THEY COULD CONSIST OF. THE UROLOGIST PERFUSELY IRRIGATED THE AREA WITH NORMAL SALINE TO WASH OUT THE SHAVINGS. NO INJURY TO PATIENT NOTED. C-ARM FLUOROSCOPY DID NOT SUGGEST THERE WERE ANY SHAVINGS RETAINED. PROBE HAS BEEN SEQUESTERED. PROCEDURE WAS FINISHED AND PATIENT SENT TO RECOVERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | PROBE, LITHOTRIPTOR, INTRACORPOREAL | FFK | RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION | 8963.435 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |