FDA Adverse Event
Injury
Summary report: N
RASPIT
MDR report key: 313951
·
Received January 24, 2001
Report
- Report Number
- MW1020927
- Event Type
- Injury
- Date Received
- January 24, 2001
- Date of Event
- January 23, 2001
- Report Date
- January 24, 2001
- Manufacturer
- BOSTON SCIENTIFIC MICROVASIVE
- Product Code
- FFL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT UNDERGOING LITHOTRIPSY PROCEDURE. RENAL STONE MOVED INTO URETER. GRASPIT FORCEP THEN USED TO SNARE STONE AND REMOVE. UPON APPLYING GRASPIT FORCEP BASKET PORTION BROKE FREE OF INSTRUMENT, BECOMING LODGED IN PT URETER. OPEN PROCEDURE THEN BEGUN FOR REMOVAL OF URETER STONE AND INSTRUMENT PIECE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3013 | RASPIT | UROLOGICAL GRASPING FORCEPS | FFL | BOSTON SCIENTIFIC MICROVASIVE | M00632040020 | 3495902 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization |