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

Model Number	5130-30151
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2023
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: 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
• Report Number: 2518443-2023-00002
• Device Sequence Number: 12316334
• Product Code: IZD
• UDI-Device Identifier: 00859942006096
• UDI-Public: 00859942006096
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: CLASS I
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown