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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS INC. VARIAN CL-IXS TRILOGY; TRILOGY SYSTEM WITH RAPIDARC
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VARIAN MEDICAL SYSTEMS INC. VARIAN CL-IXS TRILOGY; TRILOGY SYSTEM WITH RAPIDARC Back to Search Results
Model Number H14
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Bone Fracture(s) (1870)
Event Date 10/28/2014
Event Type  Injury  
Event Description
A therapist was removing a 30 degree wedge from the i/f mount and she was unable to support the weight of the accessory.She tried to control the descent; however, was not successful.She hit the couch and the impact fractured the first phalanx of her fifth finger.X-rays were taken and a plaster cast was applied to her hand.
 
Manufacturer Narrative
There was no failure or malfunction of varian hardware or software.The customer was unable to support the weight of the wedge during the process of removal.No additional f/u to this report is anticipated.Varia reference (b)(4).
 
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Brand Name
VARIAN CL-IXS TRILOGY
Type of Device
TRILOGY SYSTEM WITH RAPIDARC
Manufacturer (Section D)
VARIAN MEDICAL SYSTEMS INC.
palo alto CA
Manufacturer Contact
jeff semone, senior director
911 hansen way
palo alto, CA 94304
6504246833
MDR Report Key4287692
MDR Text Key5225144
Report Number2916710-2014-00007
Device Sequence Number1
Product Code IYE
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K072916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberH14
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/03/2014
Initial Date FDA Received11/24/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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