FDA Adverse Event
Summary report: N
KARL STORZ
MDR report key: 3162263
·
Received April 26, 2013
Report
- Report Number
- 2020550-2013-00019
- Date Received
- April 26, 2013
- Date of Event
- March 27, 2013
- Report Date
- April 24, 2013
- Manufacturer
- KARL STORZ GMBH & CO. KG
- Product Code
- GEX
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- UT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
ALLEGEDLY, THE DOCTOR WAS PERFORMING A STONE FRAGMENTATION PROCEDURE AND COULD NOT GET ENOUGH POWER TO THE LASERS TO COMPLETE FRAGMENTATION. HE ABORTED THE PROCEDURE AND RESCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183444 | KARL STORZ | CALCULASE | GEX | KARL STORZ GMBH & CO. KG | 27750101U1 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |