BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUGGLES MICRO DISSECTOR ROUND 7 1/2 INCHES

    MDR report key: 22378951 · Received July 1, 2025

    Report

    Report Number
    3014334038-2025-00089
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    February 10, 2025
    Report Date
    July 1, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    GZX
    UDI-DI
    10381780458906
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RUGGLES MICRO DISSECTOR ROUND 7 1/2 INCHES (RN6202) WAS NOT RETURNED TO THE MANUFACTURER; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE ISSUE OF DEVICE BEING DULL MAY BE THE RESULT OF CUSTOMER PREFERENCE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RUGGLES MICRO DISSECTOR ROUND 7 1/2 INCHES (RN6202) WAS "BLUNT AND NOT AS SHARP AS IT SHOULD BE". IT WAS REPORTED THAT THERE WAS AN INCREASE IN SURGERY TIME OF OVER 30 MINUTES, AS THE "DOCTOR HAD TO OPEN HIS OLD SET TO USE" TO FINALIZE THE SURGERY. NO PATIENT INJURY OR DEATH OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129610 RUGGLES MICRO DISSECTOR ROUND 7 1/2 INCHES MICROSURGICAL INSTRUMENTATION GZX INTEGRA LIFESCIENCES MANSFIELD AV2310 10381780458906

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown