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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAPINTEC, INC. CAPTUS 4000; THYROID UPTAKE SYSTEM
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CAPINTEC, INC. CAPTUS 4000; THYROID UPTAKE SYSTEM Back to Search Results
Model Number CAPTUS 4000E
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/04/2019
Event Type  malfunction  
Event Description
On (b)(6) 2019 capintec was informed that the collimator fell off a captus 4000 thyroid update system- serial number (b)(4).Technologist just completed qc on the system.She was performing capsule counts when the collimator fell off.No injuries occurred.Service personnel replaced the collimator assembly on site.User was instructed to return failed parts for evaluation.
 
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Brand Name
CAPTUS 4000
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 yusko
7 vreeland road
florham park, NJ 07932
2018259500
MDR Report Key8384799
MDR Text Key139570600
Report Number2518443-2019-00001
Device Sequence Number1
Product Code IZD
UDI-Device Identifier00859942006102
UDI-Public00859942006102
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A CLASS I
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Remedial Action Repair
Type of Report Initial
Report Date 03/02/2019
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 Health Professional
Device Model NumberCAPTUS 4000E
Device Catalogue Number5430-30152
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/04/2019
Initial Date FDA Received03/02/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/19/2016
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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