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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTEC, INC. D/B/A CIVCO RADIOTHERAPY TILTING HEAD FIXATION SYSTEM (SOLSTICE)

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MEDTEC, INC. D/B/A CIVCO RADIOTHERAPY TILTING HEAD FIXATION SYSTEM (SOLSTICE) Back to Search Results
Model Number CHS04
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/20/2019
Event Type  malfunction  
Manufacturer Narrative
Risks: during patient setup, when patient moves from inferior to superior position, the patient's motion and force against the bowl may cause rotation even when device is locked. Rotation of the bowl during the setup makes the device difficult to use. Clinicians would be required to reposition the patient if movement was detected. If movement was not detected, and confirmation image was not performed, movement could result in serious patient injury due to unintended change in patient setup location. Mitigations: if a setup confirmation image is performed prior to treatment and/or surface guided radiation therapy (sgrt) is utilized during treatment movement may be detected. Movement may also be detected by clinicians through visual confirmation of indexing positions provided on the device. The ifu also provides the following warning statements: "warning: verification image should be taken to confirm patient position prior to treatment. " and "warning: ensure device is secure prior to use". Conclusion: based on the risk of unintended movement of the device and the potential for that movement to go undetected by the clinician, a field action is being conducted. Intent to recall (1932738-4/10/19-001) was reported to the fda on 4/15/2019.
 
Event Description
User site on (b)(6) reported bowl movement noted on (b)(6) during patient setup while lock was engaged.
 
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Brand NameTILTING HEAD FIXATION SYSTEM (SOLSTICE)
Type of DeviceSOLSTICE
Manufacturer (Section D)
MEDTEC, INC. D/B/A CIVCO RADIOTHERAPY
1401 8th street se
orange city IA 51041
MDR Report Key8519209
MDR Text Key145774289
Report Number1932738-2019-00001
Device Sequence Number1
Product Code IXR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberCHS04
Device Catalogue NumberCHS04
Device Lot NumberM789110 OR M812200
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/16/2019 Patient Sequence Number: 1
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