FDA Adverse Event
Other
Summary report: N
KARL STORZ
MDR report key: 1102143
·
Received March 22, 2008
Report
- Report Number
- 2020550-2008-00008
- Event Type
- Other
- Date Received
- March 22, 2008
- Date of Event
- February 15, 2008
- Report Date
- March 20, 2008
- Manufacturer
- KARL STORZ GMBH & CO. KG
- Product Code
- FED
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DR WAS REMOVING RESECTOSCOPE AT CONCLUSION OF PROCEDURE WHEN BEAK ALLEGEDLY BROKE OFF IN PT. DR MANIPULATED BROKEN PIECE INTO BLADDER, REPOSITIONED IT AND THEN REMOVED IT WITH NO PT IMPACT. RETRIEVAL PROLONGED PROCEDURE. DR MATCHED BROKEN PIECE TO INSTRUMENT AND CONFIRMED THERE WERE NO MORE PIECES IN PT. PT CONDITION POST-OP WAS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KARL STORZ | INNER SHEATH | FED | KARL STORZ GMBH & CO. KG | 27040XA | KI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Other |