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

Model Number 5430-30141

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

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

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

Engineering is evaluting failures to determine root cause and additional corrective actions.

Event Description

Thyroid uptake system s/n (b)(6) was shipped on september 2015.The technician was performing an inspection and noted damaged cable and broken stopping pin.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
• 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: 18190382
• MDR Text Key: 328743599
• Report Number: 2518443-2023-00003
• Device Sequence Number: 1
• Product Code: IZD
• UDI-Device Identifier: 00859942006096
• UDI-Public: 00859942006096
• 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: 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
• Device Operator: Health Professional
• Device Model Number: 5430-30141
• Device Catalogue Number: 5430-30141
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2015
• 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