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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
Model Number 1002136
Device Problems Use of Device Problem (1670); Malposition of Device (2616)
Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
Event Date 03/03/2020
Event Type  Injury  
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 the headframe shifted during treatment.
 
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Brand NameLEKSELL STEREOTACTIC SYSTEM
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
ELEKTA INSTRUMENT AB
kungstensgatan 18
po box 7593
stockholm, SE103 93
SW SE103 93
Manufacturer (Section G)
ELEKTA INSTRUMENT AB
kungstensgatan 18
po box 7593
stockholm, SE103 93
SW SE103 93
Manufacturer Contact
pms
cornerstone
london road
crawley, west sussex RH10 -9BL
UK   RH10 9BL
MDR Report Key9932583
MDR Text Key196411203
Report Number9612186-2020-00004
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152558
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1002136
Device Lot Number6200
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2020
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

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