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

Model Number	5460-30141
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	10/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple arm failures under engineering investigation.Additional corrective actions pending.
Event or Problem Description
Thyroid uptake system s/n (b)(6) was shipped on april 19, 2018.The technician was performing routine qc when the system's arm unexpectedly fell to its lowest position.Review by engineering indicated a spring arm failure.No injuries occurred.A replacement assembly was shipped and user instructed to return the defective part to manufacturer for engineering evaluation and identification of root cause.The collimator and arm weigh and spring arm assembly weigh 45 pounds, which has the potential for serious injury to either 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 drive; florham park NJ 07932
• Manufacturer (Section G): MIRION TECHNOLOGIES (CAPINTEC), INC.; 77 vreeland drive; florham park NJ 07932
• Manufacturer Contact: mary yusko ; 7 vreeland road; florham park, NJ 07932 ; 2018259500
• MDR Report Key: 18190383
• Report Number: 2518443-2023-00004
• Device Sequence Number: 17953693
• Product Code: IZD
• UDI-Device Identifier: 00859942006096
• UDI-Public: 00859942006096
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/22/2023

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: 5460-30141
• Device Catalogue Number: 5460-30141
• 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: 10/27/2023
• Initial Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2019
• 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