FDA Adverse Event
Injury
Summary report: N
LEKSELL GAMMA KNIFE
MDR report key: 1317743
·
Received February 19, 2009
Report
- Report Number
- 9612186-2009-00003
- Event Type
- Injury
- Date Received
- February 19, 2009
- Date of Event
- January 22, 2009
- Report Date
- February 19, 2009
- Manufacturer
- ELEKTA INSTRUMENT AB
- Product Code
- IWB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS ONGOING. MORE INFO WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION.
Description of Event or Problem · 1
DURING INSTALLATION OF NEW HELMET HOIST ACTUATOR ASSEMBLY, THE ACTUATOR SHAFT DISCONNECTED FROM THE ACTUATOR BODY, CAUSING THE HOIST ASSEMBLY (WITHOUT HELMET ATTACHED) TO SWING DOWN. THE HOIST ASSEMBLY UNIT THEN STRUCK A FIELD SERVICE ENGINEER IN THE RIB CAGE AREA. THE FIELD SERVICE ENGINEER WAS TREATED AND RELEASED AT THE HOSPITAL THE SAME DAY OF THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEKSELL GAMMA KNIFE | SYSTEM, RADIATION THERAPY, RADIONUCLIDE | IWB | ELEKTA INSTRUMENT AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |