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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELEKTA INSTRUMENT AB LEKSELL STEREOTACTIC SYSTEM NEUROLOGICAL STEREOTACTIC INSTRUMENT, PRODUCT CODE: HAW

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ELEKTA INSTRUMENT AB LEKSELL STEREOTACTIC SYSTEM NEUROLOGICAL STEREOTACTIC INSTRUMENT, PRODUCT CODE: HAW Back to Search Results
Model Number 11868
Device Problems Degraded (1153); Device Operates Differently Than Expected (2913)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 04/05/2016
Event Type  No Answer Provided  
Event Description
During investigation of another event, some issues were found with the accuracy of the closed ct indicator box. The closed ct indicator box was attached to an empty g-frame with posts and imaged in ct. Comparison made with the same frame but with the open ct indicator box attached, shows accuracy problems with the closed ct indicator box. The device is being returned to the manufacturer facility for investigation.
 
Manufacturer Narrative
Eventually the item was returned to the manufacturer. The device is concluded to be at least 25 years old (manufactured 1990 or earlier) this explains accuracy problems. The user manual contains clear warnings that a product in this condition should not be used. The device greatly exceeds the guaranteed support of five years indicated in the user manual. Defects were found indicating extensive use and exposed to some rough handling and repairs, and was missing some parts. Joints repaired using glue that is not the correct specification and the copper fiducials were very corroded and in some places had come loose.
 
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Brand NameLEKSELL STEREOTACTIC SYSTEM
Type of DeviceNEUROLOGICAL STEREOTACTIC INSTRUMENT, PRODUCT CODE: HAW
Manufacturer (Section D)
ELEKTA INSTRUMENT AB
po box 7593
stockholm, SE103 93
SW SE103 93
Manufacturer (Section G)
ELEKTA INSTRUMENT AB
po box 7593
stockholm, SE103 93
SW SE103 93
Manufacturer Contact
pms
linac house
fleming way
crawley, west sussex RH10 -9RR
UK   RH10 9RR
MDR Report Key5619563
MDR Text Key44717889
Report Number9612186-2016-00005
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K152558
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number11868
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/29/2016 Patient Sequence Number: 1
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