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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELEKTA INSTRUMENT AB LEKSELL VANTAGE STEREOTACTIC SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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ELEKTA INSTRUMENT AB LEKSELL VANTAGE STEREOTACTIC SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 1053958
Device Problems Output Problem (3005); Inadequate Lubrication (4057)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2021
Event Type  malfunction  
Event Description
The customer reported that they have experienced that the vantage arc grib on the right side seems compromised.
 
Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has been completed.
 
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Brand NameLEKSELL VANTAGE 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 Key12810146
MDR Text Key281839737
Report Number9612186-2021-00003
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K190887
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number1053958
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/20/2021
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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