FDA Adverse Event
Other
Summary report: N
KARL STORZ
MDR report key: 3162224
·
Received April 19, 2013
Report
- Report Number
- 9610617-2013-00017
- Event Type
- Other
- Date Received
- April 19, 2013
- Manufacturer
- KARL STORZ GMBH & CO. KG
- Product Code
- GEI
- PMA / PMN Number
- K021467
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE AUTOCON WAS EVALUATED; WHEN UNIT WAS ACTIVATED, ALARM WENT OFF INDICATING ACTIVATION TIME EXCEEDED. IT WAS FOUND THAT THE BIPOLAR RESECTION MODULE THAT ATTACHES TO THE UNIT HAD SHORTED OUT.
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171244 | KARL STORZ | AUTOCON ESU | GEI | KARL STORZ GMBH & CO. KG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |