BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HURD TONSIL DISSECTOR AND PILLAR RETRACTOR

    MDR report key: 12241348 · Received July 28, 2021

    Report

    Report Number
    1527821-2021-00001
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Report Date
    July 28, 2021
    Product Code
    KBM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS A FOLLOW-UP TO THE USER FACILITY'S REPORT, FIVE ADDITIONAL HURD TONSIL DISSECTOR AND PILLAR RETRACTORS WERE INSPECTED AND WERE MADE LESS SHARP AS PER CUSTOMER'S REQUEST. THE USER FACILITY DID NOT IMPLICITLY STATE THAT STERIS IMS HAD SERVICED THE INSTRUMENT IN QUESTION PREVIOUSLY AND DID NOT MAKE ANY CLAIMS REGARDING A DEFICIENCY IN PREVIOUS REPAIRS. HURD TONSIL DISSECTOR AND PILLAR RETRACTORS CLASS 1 DEVICES ARE NOT INDIVIDUALLY SERIALIZED, SO IT IS NOT KNOWN WHICH DEVICE WAS SPECIFICALLY USED DURING THE REPORTED EVENT. IT SHOULD BE NOTED THAT THE OEM'S SPECIFICATION OF HURD TONSIL DISSECTOR AND PILLAR RETRACTORS IS THAT THE DEVICE IS SMOOTH AT THE RETRACTOR'S SIDE AND SLIGHTLY SHARP AT THE ROUNDED DISSECTOR TIP'S END. THERE ARE NO ADDITIONAL PHYSICAL SPECIFICATIONS BESIDES THE DEVICE'S LENGTH BEING 8-3/4" (22.2.CM). STERIS IMS REVIEWED ALL SERVICE DOCUMENTATION AND CONFIRMED THAT HURD TONSIL DISSECTOR AND PILLAR RETRACTORS WERE SHARPENED 16 TIMES OVER THE LAST 12 MONTHS FOR THIS CUSTOMER AND (B)(4) TIME FOR OTHER CUSTOMERS, WITHOUT ANY ISSUES OR COMPLAINTS BEING REPORTED WITHIN THE LAST 24 MONTHS. ALL SERVICE CORRESPONDING DOCUMENTATION WAS REVIEWED, AND NO ISSUES WERE IDENTIFIED. THE OEM'S IFU RECOMMENDS THAT THE DEVICE SHOULD BE INSPECTED PRIOR TO USE TO ENSURE PROPER FUNCTION AND CONDITION. DEVICES THAT DON'T SATISFACTORILY PERFORM THEIR INTENDED USE OR IF THERE ARE ANY PHYSICAL DAMAGES, SHOULD NOT BE USED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT HURD TONSIL DISSECTOR'S END OF THE HURD TONSIL DISSECTOR AND PILLAR RETRACTOR WAS SHARPER THAN PREFERRED AND THAT THE PATIENT'S TONGUE WAS CUT DURING THE PROCEDURE. THIS CUT RESULTED IN TWO STITCHES. THERE WAS NO PROCEDURE DELAY; THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE USER FACILITY DIDN'T PROVIDE THE DATE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140158 HURD TONSIL DISSECTOR AND PILLAR RETRACTOR DISSECTOR KBM

    Patients

    Seq Age Sex Outcome Treatment
    1