FDA Adverse Event
Other
Summary report: N
KARL STORZ
MDR report key: 933371
·
Received October 12, 2007
Report
- Report Number
- 2020550-2007-00027
- Event Type
- Other
- Date Received
- October 12, 2007
- Date of Event
- August 6, 2007
- Report Date
- October 4, 2007
- Manufacturer
- KARL STORZ GMBH & CO. KG
- Product Code
- LQS
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DR WAS TESTING UNIT BEFORE PROCEDURE. A BIOTECH WAS HOLDING THE PROBE AND A CONTAINER OF WATER TO FIRE PROBE IN FOR TESTING PURPOSES. DR ACTIVATED UNIT PREMATURELY AND BIOTECH RECEIVED A SHOCK WHICH LEFT A RED MARK ON HER HAND. SHE WAS SENT TO EMERGENCY, WHERE SHE WAS GIVEN AN EKG. THERE WERE NO ISSUES FOUND, BUT SHE WAS SENT HOME AS A PRECAUTION. NO MEDICAL TREATMENT WAS NECESSARY. WHEN SHE RETURNED TO THE HOSP, SHE WAS CHECKED AGAIN, AND AGAIN MEDICAL TREATMENT WAS UNNECESSARY; SHE WAS RELEASED BACK TO WORK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KARL STORZ | CALCUTRIPT - LITHOTRIPTER | LQS | KARL STORZ GMBH & CO. KG | 27080C | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |