FDA Adverse Event
Malfunction
Summary report: N
LEKSELL GAMMA KNIFE
MDR report key: 1729837
·
Received June 15, 2010
Report
- Report Number
- 9612186-2010-00003
- Event Type
- Malfunction
- Date Received
- June 15, 2010
- Date of Event
- May 14, 2010
- Report Date
- June 14, 2010
- Manufacturer
- ELEKTA INSTRUMENT AB
- Product Code
- IWB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS ON-GOING, SO F/U REPORTING TO THIS MDR WILL BE PROVIDED TO FDA UPON COMPLETION.
Description of Event or Problem · 1
AFTER REMOVING A HELMET FROM THE MACHINE AND CARRIER, THE CUSTOMER WAS LOWERING THE HELMET CHANGER IN PREPARATION FOR PICKING UP THE NEXT HELMET, THE CHANGER-LIFTER (WITHOUT A HELMET ATTACHED) SUDDENLY DROPPED TO THE HELMET FROM THE MID POINT OF ITS DOWNWARD MOTION RESULTING IN A BANG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEKSELL GAMMA KNIFE | SYSTEM, RADIATION THERAPY, RADIONUCLIDE | IWB | ELEKTA INSTRUMENT AB | MODEL 4C | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |