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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 1000689
Device Problems Misassembled (1398); Device Slipped (1584); Unintended Movement (3026)
Patient Problems Hemorrhage, Cerebral (1889); Brain Injury (2219)
Event Date 03/06/2017
Event Type  Injury  
Manufacturer Narrative
Update: 28th july 2017: the device has been returned to elekta and investigation is currently ongoing. To date, the ongoing investigation has shown a "false" locking of the multipurpose arc to the arc support, can occur, most likely caused by insufficient lubrication. Further investigation is needed to confirm this. Target date for finalizing the investigation is august 20, 2017. This is the first reported event regarding a locking mechanism becoming loose for the arc supports. Elekta has an installed base of over (b)(4) systems worldwide, over a time period of >10 years. Elekta therefore consider the probability of such a fault to occur as low. The patient had an extreme tremor and restless legs, meaning there was movement and vibration during surgery. A bleed occurred due to the change of arc position. The md carried out a craniotomy after to remove the hemorrhage that was caused. On the (b)(6) 2017, the patient was still in recovery. The surgeon cannot say if the patient will recover from the injury. Follow up of the patient status is done continuously.
 
Manufacturer Narrative
Additional information: manufacturer's investigation results elekta has completed it's investigation. The equipment was delivered to the customer in (b)(6) 2009, so the system is 8 years old. At the time of the event a homemade microdrive was used. On examination of the system signs of wear and tear were clearly visible. The test in the verification test tools indicates no deviation of target accuracy. At inspection of the system it is noticed that it is difficult to get a firm fixation of the arc angle. A false locking appears when trying to fasten the rings, a failure that was possible to reproduce during the investigation. When sparingly lubricating the rings, the false locking was not possible to repeat. The instruction for use has instructions on how to maintain the system, including information that the system shall be lubricated. It also includes warnings regarding the importance of a secured locking of the arc, and that inspection shall be performed before treatment. If damage to the system is suspected, elekta shall be contacted. Root cause of problem: the multipurpose arc involved in the incident is 8 years old. The probable root cause of the problem is absence of lubrication of the axis rings and locking pieces of the arc. Lubrication is even more important for systems above the expected life length of 5 years. Due to the normal wear and tear, the surface of the system is over time affected and there is a need to regularly perform maintenance of the system. Locking and sliding surfaces that get rough over time may cause a "false" locking of the arc, meaning that the locking piece gets stuck to the axis ring in an incorrect position. If the system is exposed to repeated large vibrations or movements, such as in this case severe tremor and restless legs, the locking mechanism can became loose and may cause a change of setting. Correction actions: the customer has been informed of the need to perform regular maintenance of the system. Elekta guarantees a system life length of five years. Elekta has recommended to the customer to replace the arc with a new one as it has passed the expected life length of five years and has demonstrated problems with the locking for a period of time. The instructions for use will be updated with extended instruction on how to lubricate the multipurpose arc.
 
Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
 
Event Description
It has been reported that the surgeon tightened the set screws of the leksell multi-purpose stereotactic arc system as much as possible, but during the final trajectory mapping when the patient became drowsy it was noticed that the arc had slipped a few degrees. This resulted in the movement of the guide tube through the brain. The patient developed an intra cerebral hemorrhage, the procedure was aborted, an urgent craniotomy was performed to stop the hemorrhage.
 
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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
fleming way
crawley, west sussex RH10 -9RR
UK   RH10 9RR
MDR Report Key6489410
MDR Text Key110088796
Report Number9612186-2017-00005
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K080355
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1000689
Device Catalogue Number1000689
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/12/2017
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

Patient Treatment Data
Date Received: 04/13/2017 Patient Sequence Number: 1
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