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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELEKTA INSTRUMENT AB LEKSELL STEREOTACTIC SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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ELEKTA INSTRUMENT AB LEKSELL STEREOTACTIC SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Device Problems Labelling, Instructions for Use or Training Problem (1318); Product Quality Problem (1506)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
 
Event Description
The customer reported that they are concerned regarding the accuracy of the arc of the g frame.
 
Manufacturer Narrative
Updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.The system has been investigated by brainlab who have concluded that there was a lack of lubrication.Initial tests of the system showed that there were problems in movement and locking.After cleaning and lubrication of the system, according to instructions for use maintenance section, it works as intended.The user has been informed by brainlab regarding the importance of lubrication.
 
Event Description
The customer reported that they are concerned regarding the accuracy of the arc of the g frame.
 
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Brand Name
LEKSELL STEREOTACTIC SYSTEM
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
ELEKTA INSTRUMENT AB
kungstensgatan 18
po box 7593
stockholm, SE103 93
SW  SE103 93
MDR Report Key8424504
MDR Text Key139114646
Report Number9612186-2019-00004
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
K152558
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 05/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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