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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELEKTA INSTRUMENT AB LEKSELL GAMMA KNIFE PERFEXION; SYSTEM, RADIATION THERAPY, RADIONUCLIDE
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ELEKTA INSTRUMENT AB LEKSELL GAMMA KNIFE PERFEXION; SYSTEM, RADIATION THERAPY, RADIONUCLIDE Back to Search Results
Device Problems Malposition of Device (2616); Device Operates Differently Than Expected (2913); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The customer has reported that they are concerned that the frame adaptor is able to be placed on the qa tool when the locking clamps are in the incorrect position.There is about 1-2mm of play.This was picked up during morning qa focus check when the results came back failing.
 
Manufacturer Narrative
The manufacturer's investigation is currently on-going.Further information will be provided when the investigation has been completed.
 
Manufacturer Narrative
The leksell gamma knife perfexion coordinate frame is fixed to the patient positioning system before treatment using a frame adapter.The coordinate frame is locked to the frame adapter via latches.The latches are turned ninety degrees and then locked.The manufacturer's investigation have shown that it may be possible to have a situation where the adapter latches can get stuck just above the coordinate frame surface and as a result the coordinate frame will not be fixed properly.This could then result in a small play between the coordinate frame and the frame adapter in the leksell z-direction.A small "shelf" can be created if the latch has been forced into position when at a small angle.If the latch locks to that shelf there will be a play between the frame and the latch, which could possibly move the target from planned position by up to 0.5 mm.The root cause is that frame adapters have not been manufactured according to specification.A field safety corrective notice (100-01-202-027) will be released to customers.
 
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Brand Name
LEKSELL GAMMA KNIFE PERFEXION
Type of Device
SYSTEM, RADIATION THERAPY, RADIONUCLIDE
Manufacturer (Section D)
ELEKTA INSTRUMENT AB
p.o. box 7593
stockholm, 103- 93
SW  103-93
Manufacturer Contact
linac house
fleming way
crawley, west sussex RH10 -9RR
MDR Report Key3842894
MDR Text Key16010128
Report Number9612186-2014-00003
Device Sequence Number1
Product Code IWB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K120811
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation Physicist
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physicist
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/06/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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