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

Model Number 5430-30152

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

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

Event Date 12/20/2023

Event Type  malfunction  

Event Description

Captus 4000e thyroid uptake system s/n (b)(6) was shipped to (b)(6) medical center (now (b)(6)health) on february 5, 2021.The nuclear medicine technician was performing quality assurance.The collimator unexpected detached from the system arm.Prior to this event, the system had been functioning properly.No injury was reported by the operator.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.

Manufacturer Narrative

System was shipped on feb.5 2021, and is 3 years old.Pictures sent by end user indicate that the retention pin plate failed.End user is in process of returning defective assembly to manufacturer for engineering investigation and confirmation of root cause.Component not yet received at time of this report.

• Brand Name: CAPTUS 4000E THYROID UPTAKE SYSTEM
• Type of Device: THYROID UPTAKE SYSTEM
• Manufacturer (Section D): MIRION TECHNOLOGIES (CAPIINTEC), INC.; 7 vreeland road; florham park NJ 07932
• Manufacturer (Section G): MIRION TECHNOLOGIES (CAPINTEC) INC.; 7 vreeland drive; florham park NJ 07932
• Manufacturer Contact: mary yusko ; 7 vreeland road; florham park, NJ 07932 ; 2018259500
• MDR Report Key: 18485762
• MDR Text Key: 333097714
• Report Number: 2518443-2024-00001
• Device Sequence Number: 1
• Product Code: IZD
• UDI-Device Identifier: 00859942006102
• UDI-Public: 00859942006102
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/10/2024

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: 5430-30152
• Device Catalogue Number: 5430-30152
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2021
• 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