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

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.

• Brand Name: TILTING HEAD FIXATION SYSTEM (SOLSTICE)
• Type of Device: SOLSTICE
• Manufacturer (Section D): MEDTEC, INC. D/B/A CIVCO RADIOTHERAPY; 1401 8th street se; orange city IA 51041
• MDR Report Key: 8519209
• MDR Text Key: 145774289
• Report Number: 1932738-2019-00001
• Device Sequence Number: 1
• Product Code: IXR
• UDI-Device Identifier: 00841439112496
• UDI-Public: 00841439112496
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CHS04
• Device Catalogue Number: CHS04
• Device Lot Number: M789110 OR M812200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other