FDA Adverse Event
Malfunction
Summary report: N
FLEXVISION U-500 FLEXIBLE URETEROSCOPE
MDR report key: 1030258
·
Received April 15, 2008
Report
- Report Number
- 2936485-2008-00028
- Event Type
- Malfunction
- Date Received
- April 15, 2008
- Date of Event
- March 6, 2008
- Report Date
- March 17, 2008
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- FGB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS ON GOING. ADDITIONAL INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED BY THE SALES REP, THAT DURING A CASE, A PIECE OF BLADDER STONE GOT STUCK BETWEEN THE URETER WALL AND THE SCOPE AS THE DR WAS RETRIEVING THE SCOPE OUT. THE SCOPE WAS LEFT IN THE PT FOR APPROX 48 HOURS TO DILATE THE URETER. THEY WERE ABLE TO RETRIEVE THE SCOPE. NO INJURIES TO THE PT WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXVISION U-500 FLEXIBLE URETEROSCOPE | IMPLANT | FGB | STRYKER ENDOSCOPY SAN JOSE | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |