BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUGGLES MICRO DISSECTOR - SPATULA - SMALL - 7 1/

    MDR report key: 22379165 · Received July 1, 2025

    Report

    Report Number
    3014334038-2025-00090
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    February 10, 2025
    Report Date
    August 4, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    GZX
    UDI-DI
    10381780458944
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: G3, G6, H2, H6/F10(MEDICAL DEVICE PROBLEM CODES), H11 ADDITIONAL INFORMATION FROM THE CUSTOMER RECEIVED ON 02-MAY-2025 INDICATED THAT THE SIZE WAS ACCEPTABLE. THIS ISSUE MAY BE THE RESULT OF USER PREFERENCE. THERE HAS BEEN NO RETURN OF PRODUCT FOR EVALUATION. THE DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE RUGGLES MICRO DISSECTOR - SPATULA - SMALL -RN6206) 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 THE DEVICE BEING THE WRONG SIZE MAY BE THE RESULT OF CUSTOMER PREFERENCE FOR ANOTHER PRODUCT. IF 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.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B5, G3, G6, H2, H6/F10 (MEDICAL DEVICE PROBLEM CODES).

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RUGGLES MICRO DISSECTOR - SPATULA - SMALL - 7 1/ (RN6206) WAS NOT AS SHARP AS EXPECTED, IT WAS BLUNT. THERE WAS NO PATIENT INJURY; HOWEVER, AN INCREASE IN SURGICAL TIME, GREATER THAN 30 MINUTES WAS REPORTED AS THEY HAD TO GET THE OLD SET FOR BOTH PRODUCTS. THE SURGERY WAS COMPLETED WITH ANOTHER PRODUCT AVAILABLE AT THE HOSPITAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RUGGLES MICRO DISSECTOR - SPATULA - SMALL - 7 1/ (B)(6) WAS SMALLER THAN WHAT WAS PREVIOUSLY ORDERED BY THE HOSPITAL. THERE WAS NO PATIENT INJURY; HOWEVER, AN INCREASE IN SURGICAL TIME, GREATER THAN 30 MINUTES WAS REPORTED AS THEY HAD TO GET THE OLD SET FOR BOTH PRODUCTS. THE SURGERY WAS COMPLETED WITH ANOTHER PRODUCT AVAILABLE AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142059 RUGGLES MICRO DISSECTOR - SPATULA - SMALL - 7 1/ N/A GZX INTEGRA LIFESCIENCES MANSFIELD AV2304 10381780458944

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown