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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAPINTEC, INC. CAPTUS 3000 THYROID UPTAKE SYSTEM
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CAPINTEC, INC. CAPTUS 3000 THYROID UPTAKE SYSTEM Back to Search Results
Model Number 5430-0077
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/04/2018
Event Type  malfunction  
Event Description
On (b)(6) 2018 capintec was informed of an arm failure on a captus 3000 thyroid update system- serial number (b)(4).A component in the spring arm (tension rod) broke causing the arm with the collimator to fall downward.The patient was seated in a chair and the technologist was preparing to perform a thyroid uptake procedure on the patient.No injury occurred.
 
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Brand Name
CAPTUS 3000 THYROID UPTAKE SYSTEM
Type of Device
THYROID UPTAKE SYSTEM
Manufacturer (Section D)
CAPINTEC, INC.
7 vreeland road
florham park NJ 07932
Manufacturer (Section G)
CAPINTEC, INC.
7 vreeland road
florham park NJ 07932
Manufacturer Contact
mary anne yusko
7 vreeland road
florham park, NJ 07932
2018259500
MDR Report Key8026941
MDR Text Key126358826
Report Number2518443-2018-00001
Device Sequence Number1
Product Code IZD
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
CLASS I,EXEM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Biomedical Engineer
Remedial Action Replace
Type of Report Initial
Report Date 10/31/2018
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 Number5430-0077
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/04/2018
Initial Date FDA Received10/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/22/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number2518443-11/01/18-001-C
Patient Sequence Number1
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