MAUDE Adverse Event Report: CAPINTEC, INC. CAPTUS 3000 THYROID UPTAKE SYSTEM

Model Number 5430-0077

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2018

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.No staff or patient was in the room at the time of the event.No injury occurred.

• 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): MARY ANNE YUSKO; 7 vreeland road; florham park NJ 07932
• Manufacturer Contact: mary yusko ; capintec, inc.; 7 vreeland road; florham park, NJ 07932 ; 2018259500
• MDR Report Key: 8154548
• MDR Text Key: 130328490
• Report Number: 2518443-2018-00002
• Device Sequence Number: 1
• Product Code: IZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: CLASS I,EXEM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/12/2018

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 Number: 5430-0077
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1