BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3DIMENSIONS

    MDR report key: 19601192 · Received June 24, 2024

    Report

    Report Number
    1220984-2024-00064
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    June 9, 2024
    Report Date
    August 5, 2025
    Manufacturer
    HOLOGIC, INC
    Product Code
    OTE
    UDI-DI
    15420045510579
    PMA / PMN Number
    P080003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE 510K FOR THIS PRODUCT IS P080003.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE ROTARY SWITCH WAS GETTING STUCK, UNINTENTIONALLY ROTATING THE C-ARM. REPLACEMENT OF THE ROTARY SWITCH WAS PROPOSED. THE FIELD ENGINEER (FE) REPLACED THE SWITCH TO RESOLVE THE ISSUE. NO PATIENT OR USER INJURY WAS REPORTED. A REVIEW OF THIS DEVICE¿S HISTORY SHOWED THAT THE ISSUE DID NOT RETURN AFTER THE ROTARY SWITCH WAS REPLACED. THE ROTARY SWITCH WAS REPLACED; HOWEVER, NO PARTS WERE RETURNED FOR FURTHER INVESTIGATION. THE ROTARY SWITCH WAS 349 DAYS OLD AT THE TIME OF REPLACEMENT. THE PART WAS NOT RETURNED FOR FURTHER INVESTIGATION. THE PROBABLE CAUSE OF THE UNCOMMANDED MOVEMENT IS DUE TO AN ISSUE WITH THE ROTARY SWITCH. FURTHER INVESTIGATION COULD NOT BE PERFORMED AS THE PART WAS NOT RETURNED. DUE TO THE LIMITED INFORMATION PROVIDED AND LACK OF PART RETURN, THE ROOT CAUSE OF THE ROTARY SWITCH FAILURE COULD NOT BE DETERMINED. CONCLUSION: BASED ON A REVIEW OF THE COMPLAINT, A CAPA IS NOT NEEDED AT THIS TIME AS THERE WAS NO PATIENT OR USER HARM. ADDITIONALLY, THE RISK IS CONSIDERED VERY LOW BASED ON THE OCCURRENCE. FUTURE EVENTS WILL BE MONITORED AND TRENDED. COMPLAINT CONFIRMED: NO. DEVICE HISTORY RECORD (DHR) REVIEW: A REVIEW OF THE COMPLAINT HISTORY FOR (B)(6) SHOWED NO ADDITIONAL COMPLAINTS FOR UNCOMMANDED C-ARM MOVEMENT RELATED TO THE ROTARY SWITCH. THE COMPLAINT REVIEW IDENTIFIED THE ROTARY SWITCH WAS ORIGINAL TO THE SYSTEM THEREFORE, THE DHR WAS REVIEWED. THERE WERE NO DISCREPANCIES RELATED TO THE ROTARY SWITCH. SYSTEM PRODUCT CODE: 3DM-SYS-INTL3D, SERIAL NUMBER: (B)(6), SYSTEM MANUFACTURE DATE: NOVEMBER 14TH, 2022, SYSTEM INSTALLATION DATE: ON (B)(6) 2023, UNIQUE DEVICE IDENTIFIED (UDI): (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6), THAT A 3DIMENSIONS WAS MOVING BY ITSELF DUE TO A SWITCH GETTING STUCK. THE FIELD ENGINEER EXAMINED THE DEVICE AND FOUND THAT A ROTARY SWITCH MIGHT HAVE MECHANICAL ISSUE. THE FIELD ENGINEER REPLACED THE DEFECTIVE SWITCH AND TESTED FUNCTIONALITY. THE SYSTEM IS FUNCTIONING PROPERLY AND MEETS ALL MANUFACTURER SPECIFICATIONS. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442503 3DIMENSIONS MAMMOGRAPHY SYSTEM OTE HOLOGIC, INC 3DM-SYS-INTLD3D 15420045510579

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown