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

Model Number 5430-301542

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2020

Event Type  malfunction  

Event Description

On (b)(6) 2020, the lead nuclear medicine technologist from (b)(6) contacted capintec to report that the collimator detached from the spring arm of their captus 4000e system, s/n (b)(4).The collimator assembly weighs 28 pounds, and there is the potential for injury if the collimator were to fall and come into contact with a patient or operator.The patient was seated on a chair and the technologist was preparing to measure the patient's thyroid.The technologist was able to hold the collimator to prevent it from falling.No injury occured 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
• Manufacturer (Section G): MIRION TECHNOLOGIES (CAPINTEC), INC.; 7 vreeland road; florham park, nj
• Manufacturer Contact: mary yusko ; 7 vreeland road; florham park, nj ; 8259500312
• MDR Report Key: 10228437
• MDR Text Key: 200033286
• Report Number: 2518443-2020-00001
• 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: CLASS I
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 07/02/2020

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: 5430-301542
• Device Catalogue Number: 5430-301542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 07/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: RES 85237 Z-1564-2020
• Patient Sequence Number: 1