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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 Device Slipped (1584); Device Issue (2379)
Patient Problem No Information (3190)
Event Date 06/25/2007
Event Type  malfunction  
Manufacturer Narrative
The investigation has been performed based upon the information given by the hospital. As the incidents occurred between 8 to 14 years ago, the information from the events are limited. There is no information on what products were used at the time of the incidents (e. G. Frame, posts or fixation screws), but according to the neurosurgeon there was no evidence that equipment failure was involved in the events. The equipment is therefore excluded to the cause of the incidents. Due to the time span of the occurrence of the events, it has not been possible to identify the root cause of the incident. A probable root cause may be that the frame was not firmly attached to the patient skull prior to treatment, and/or patient movement during gamma knife treatment. No field safety corrective action would be initiated.
 
Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed; however, the physician has informed that they believe that there was no evidence that equipment failure was involved.
 
Event Description
During investigation of mfr no. 9612186-2017-00008 (elekta ref. # (b)(4)), additional information of frame slippage incidents were received from the customer. The customer has reported that the frame came loose prior to the remaining 6 of 12 treatment shots/positions. A second frame fixation was then used to complete the 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
linac house
flemming way
crawley, west sussex RH10 -9RR
UK   RH10 9RR
MDR Report Key6944020
MDR Text Key133550734
Report Number9612186-2017-00013
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972324
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Physicist
Type of Report Initial,Followup
Report Date 02/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/13/2017
Was Device Evaluated by Manufacturer? No
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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