FDA Adverse Event
Other
Summary report: N
KARL STORZ
MDR report key: 1357739
·
Received April 1, 2009
Report
- Report Number
- 9610617-2009-00009
- Event Type
- Other
- Date Received
- April 1, 2009
- Date of Event
- March 3, 2009
- Report Date
- March 31, 2009
- Manufacturer
- KARL STORZ GMBH & CO. KG
- Product Code
- GEN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FORCEPS IS ABOUT 5 YEARS OLD, AND THE DAMAGE IS MOST LIKELY DUE TO THE BREAKAGE.
Description of Event or Problem · 1
DOCTOR WAS PERFORMING A FOREIGN BODY REMOVAL PROCEDURE, WHEN ONE OF THE GRASPER JAWS BROKE OFF INSIDE THE PT. THE BROKEN JAW PIECE WAS RETRIEVED. PROCEDURE WAS COMPLETED WITH NO IMPACT ON THE PT, EXCEPT FOR AN EXTENDED PROCEDURE TIME OF 1 HOUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KARL STORZ | OPTICAL FORCEPS | GEN | KARL STORZ GMBH & CO. KG | 10350K | AF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |