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

Model Number	5430-30152
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)
Type of Reportable Event	Malfunction
Event or Problem Description
Thyroid uptake system s/n (b)(6) was shipped on 2/23/2016.The technician was performing a thyroid uptake on patient when the 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.
Additional Manufacturer Narrative
Safety alert sent to installed base of potentially suspect units.Additional corrective actions pending completed engineering analysis.

• Brand Name: CAPTUS 4000 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: 18236365
• Report Number: 2518443-2023-00005
• Device Sequence Number: 16938082
• Product Code: IZD
• UDI-Device Identifier: 00859942006096
• UDI-Public: 00859942006096
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Notification
• Type of Report: Initial

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 Expiration Date: 02/23/2026
• Device Model Number: 5430-30152
• Device Catalogue Number: 5430-30152
• 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: 11/14/2023
• Initial Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2016
• 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