BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROAIRE LIPOSCULPTOR HANDPIECE

    MDR report key: 23137099 · Received September 24, 2025

    Report

    Report Number
    1527821-2025-00019
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    August 27, 2025
    Report Date
    September 24, 2025
    Manufacturer
    STERIS CORPORATION
    Product Code
    QPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER THOROUGH EVALUATION OF THE RETURNED DEVICE, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE CONNECTING BAR AND BLADE RETAINING PIN WERE REPLACED BY THE ORIGINAL OUTSOURCE REPAIR VENDOR AND THE DEVICE WAS RETURNED TO STERIS WHERE IT PASSED OUTGOING QUALITY INSPECTION AND WAS RETURNED TO THE USER FACILITY TO BE PLACED BACK IN SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED, AND NO SIMILAR ADVERSE EVENTS HAVE OCCURRED FOR THIS DEVICE IN THE PAST. STERIS IS NOT THE MANUFACTURER OF THE DEVICE; THEREFORE UDI WAS NOT INCLUDED IN THE MDR.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OCCURRED DURING THE FIRST USE OF THE DEVICE SINCE IT WAS REPAIRED ON 16 JULY 2025. ON 28 AUGUST 2025 THE DEVICE IN QUESTION WAS RECEIVED INTO THE LAB THEN FORWARDED TO THE ORIGINAL OUTSOURCE SERVICE SUPPLIER FOR EVALUATION. THE SUPPLIER DETERMINED THAT THE PRESS-FIT BLADE RETAINING PIN HAD DETACHED FROM THE DEVICE HOUSING POST-REPAIR, PRIOR TO USE BY THE USER, HOWEVER, THE EXACT CAUSE FOR THE COMPONENT LOOSENING HAS NOT YET BEEN DETERMINED. NO SIMILAR ADVERSE EVENTS HAVE OCCURRED FOR THIS DEVICE IN THE PAST. . THE DETACHED BLADE RETAINING PIN WAS REINSTALLED ON THE DEVICE AND RETURNED TO STERIS. ON 12 SEPTEMBER 2025 THE REPAIRED DEVICE WAS INSPECTED AT STERIS STL, PASSED OUTGOING QC INSPECTION, AND WAS RETURNED TO THE CUSTOMER. THE INVESTIGATION IS STILL IN PROGRESS. STERIS IS NOT THE MANUFACTURER OF THE DEVICE; THEREFORE, UDI WAS NOT INCLUDED IN THE MDR.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THEIR MICROAIRE LIPOSCULPTOR HANDPIECE STARTED MAKING AN UNUSUAL NOISE AND THEN CAME APART IN THE SURGEON'S HAND WHEN THEY WERE PREPARING TO USE IT DURING A PATIENT PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. NO REPORT OF INJURY OR PROCEDURE DELAY.

    Description of Event or Problem · 0

    ON 27 AUGUST 2025, STERIS WAS NOTIFIED BY THE USER FACILITY THAT THEIR MICROAIRE LIPOSCULPTOR HANDPIECE STARTED MAKING AN ODD NOISE AND THEN CAME APART IN THE SURGEON'S HAND WHEN THEY WERE PREPARING TO USE IT DURING A PROCEDURE. NO INJURIES AND/OR PROCEDURAL DELAYS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2493163 MICROAIRE LIPOSCULPTOR HANDPIECE MICROAIRE LIPOSCULPTOR HANDPIECE QPB STERIS CORPORATION PAL-650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown