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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCURAY INCORPORATED TOMOTHERAPY HI-ART TREATMENT SYSTEM; TOMOTHERAPY TREATMENT SYSTEM

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ACCURAY INCORPORATED TOMOTHERAPY HI-ART TREATMENT SYSTEM; TOMOTHERAPY TREATMENT SYSTEM Back to Search Results
Model Number H-0000-0003
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/02/2016
Event Type  malfunction  
Manufacturer Narrative
A complaint was recently received for a problem involving a flex pivot joint failure.The primary collimation system is comprised of two jaws that control the width (thickness) of the radiation beam.The two halves of the jaw are opened and closed with electric actuators.These actuators are held on mounting brackets by flex pivots which allow rotation while providing a tight fit.In this case, the flex pivot joints cracked (likely due to a torque issue), and the width of the radiation beam was not appropriately collimated resulting in under-dose by 2-11%.Subsequent compensating fractions were delivered according to a physician approved treatment plan.We were informed that the customer/user submitted a medwatch report.
 
Event Description
A complaint was recently received for a problem involving a flex pivot joint failure.
 
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Brand Name
TOMOTHERAPY HI-ART TREATMENT SYSTEM
Type of Device
TOMOTHERAPY TREATMENT SYSTEM
Manufacturer (Section D)
ACCURAY INCORPORATED
1310 chesapeake terrace
sunnyvale CA 94089
Manufacturer (Section G)
ACCURAY INCORPORATED
1209 deming way
madison WI 53717
Manufacturer Contact
matthew vandervoort
1310 chesapeake terrace
sunnyvale, CA 94089
4087164666
MDR Report Key6140277
MDR Text Key61539808
Report Number3003873069-2016-00002
Device Sequence Number1
Product Code IYE
UDI-Device IdentifierM6581043090
UDI-PublicM6581043090
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121934
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Remedial Action Repair
Type of Report Initial
Report Date 12/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberH-0000-0003
Device Catalogue NumberH-0000-0003
Device Lot NumberN/A
Initial Date Manufacturer Received 11/02/2016
Initial Date FDA Received12/01/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/30/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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