FDA Adverse Event
Other
Summary report: N
2137
MDR report key: 634744
·
Received September 6, 2005
Report
- Report Number
- 634744
- Event Type
- Other
- Date Received
- September 6, 2005
- Date of Event
- September 1, 2005
- Report Date
- September 6, 2005
- Manufacturer
- RICHARD WOLF MEDICAL INSTRUMENTS CORP
- Product Code
- FEO
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
PROBLEM: DURING A LITHOTRIPSY PROCEDURE IN THE MAIN O.R., THE PROBES STARTED SPARKING INSIDE THE PATIENT. THE LITHOTRIPTER WAS IDENTIFIED AS MFG. BY R. WOLF, MODEL 2137. THE USERS WERE NOT CERTAIN WHETHER THIS OCCURRENCE WAS THE RESULT OF A MALFUNCTION IN THE EQUIPMENT , WHICH INCLUDES THE 9 FR PROBE, OR A RESULT OF THE USERS TECHNIQUE. BIOMEDICAL ENGINEERING COULD NOT DETECT A FAULT, SO THE MANUFACTURER WAS CONTACTED. THEY ADVISED US TO SEND IT TO THEM FOR EVALUATION, WHICH WE DID. (RMA # 06994)THE PATIENT WAS NOT HARMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2137 | LITHOTRIPTER, INTRACORPOREAL | FEO | RICHARD WOLF MEDICAL INSTRUMENTS CORP | 2137 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |