MAUDE Adverse Event Report: MIRION TECHNOLOGIES (CAPINTEC), INC. CAPTUS 4000E THYROID UPTAKE SYSTEM

Model Number 5130-30151

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2023

Event Type  malfunction  

Event Description

Captus 4000e thyroid uptake system s/n (b)(6) was shipped to rapp-iso gmbh, germany in august 2020.On june 24, 2023 the technician attempted to operate the captus 4000e to measure a phantom.The probe unexpectedly dislodged from the carriage arm.The arm's articulation had become loose and eventually detached.Prior to this event, the system had been functioning properly.User reported no injury.The collimator assembly weighs 28 pounds, and there is the potential for serious injury if the collimator were to fall and come into contact with a patient or operator.

• Brand Name: CAPTUS 4000E THYROID UPTAKE SYSTEM
• Type of Device: THYROID UPTAKE SYSTEM
• Manufacturer (Section D): MIRION TECHNOLOGIES (CAPINTEC), INC.; 7 vreeland road; florham park NJ 07932
• Manufacturer (Section G): MIRION TECHNOLOGIES (CAPINTEC), INC.; 7 vreeland road; florham park NJ 07932
• Manufacturer Contact: mary yusko ; 7 vreeland road; florham park, NJ 07932 ; 2018259500
• MDR Report Key: 17539463
• MDR Text Key: 321280768
• Report Number: 2518443-2023-00002
• Device Sequence Number: 1
• Product Code: IZD
• UDI-Device Identifier: 00859942006096
• UDI-Public: 00859942006096
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: CLASS I
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/11/2023

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: 5130-30151
• Device Catalogue Number: 5130-30151
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/27/2020
• 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