FDA Adverse Event
Other
Summary report: N
LITHOTRIPTER PROBE, 3.5 FR
MDR report key: 16581
·
Received October 4, 1994
Report
- Report Number
- MW1003583
- Event Type
- Other
- Date Received
- October 4, 1994
- Date of Event
- August 23, 1994
- Report Date
- September 19, 1994
- Manufacturer
- RICHARD WOLF MEDICAL INSTRUMENTS CORP.
- Product Code
- FFK
- Report Source
- Voluntary report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING OR PROCEDURE TO REMOVE RIGHT URETERAL STENT ON 8/23/94; FOREIGN BODY NOTED ON X-RAY IN RIGHT URETER. FOREIGN BODY BELIEVED TO BE LITHOTRIPTER PROBE TIP THAT WAS UTILIZED ON SURGICAL PROCEDURE DATED 8/12/94.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LITHOTRIPTER PROBE, 3.5 FR | LITHOTRIPTER PROBE | FFK | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | 021931 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Other |