BEUDAMED
    FDA Adverse Event Other Summary report: N

    STR 60" CENTURY HC DOMESTIC HINGE

    MDR report key: 1023765 · Received March 24, 2008

    Report

    Report Number
    2515984-2008-00004
    Event Type
    Other
    Date Received
    March 24, 2008
    Date of Event
    February 20, 2008
    Report Date
    March 21, 2008
    Manufacturer
    STERIS CORPORATION-ERIE
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    STERIS TECHNICIAN REPLACED THE DAMAGED PARTS ALLOWING THE PANEL OPENS AND CLOSES PROPERLY. ACCORDING TO THE DESCRIPTION OF THIS EVENT, THIS ISSUE LOOKS LIKE A MISUSE FROM THE USER ONCE THAT THE PROBLEM WAS FIXED TEMPORARILY USING A STERILE TAPE, AND THE PROBLEM WAS NOT REPORTED TO STERIS TECHNICAL SERVICE UNTIL THE ACCIDENT OCCURRED. MONTERREY PLANT INSPECTED THE CURRENT PROCESS AND NOT FOUND ANY PROBLEM RELATED TO THIS EVENT. BOTTOM PANEL IS PROCESSED ACCORDING TO MANUAL 46665-563/568 REV. A 05/15/07. THERE IS EVIDENCE OF PROCESS INSPECTION RECORD IN FABRICATION AREA. A VISUAL AID WAS IMPLEMENTED TO IMPROVE AND ASSURE THE PROCESS OF THE PART IN THE OPERATION ON 09-03-07 (VISUAL AID #176 REV. A).

    Description of Event or Problem · 1

    WHEN THE OPERATOR ATTEMPTED TO OPEN THE MAIN STERILIZER DOOR, THE SERVICE PANEL FELL ON HIS FOOT. HE WAS TAKEN TO THE ER AND RETURNED AT WORK THE NEXT DAY AND WAS REPORTED TO BE FINE. THE SERVICE STERIS TECHNICIAN (ALEX DIAZ) FOUND THAT THE BOTTOM PANEL WAS CLOSED AND THE SERVICE PANEL WAS HELD CLOSELY BY A STERILE TAPE. HE FOUND THE UPRIGHT SUPPORT BRACKET WAS MISSED, THE UPRIGHT SUPPORT AND HINGES BENT, NOT ALLOWING A PROPER CONTACT OF THE MAGNETIC CATCHES. THE SUPERVISOR ASKED TO THE STERIS TECHNICIAN IF THERE WAS A PROTOCOL TO TAPE THE BOTTOM SERVICE PANEL, BUT IS UNKNOWN HOW THE TAPE WAS HOLDING THE DOOR GOT THERE. IF THE DOOR WAS DAMAGED A SIGN SHOULD HAVE BEEN PUT ON IT, AND A SERVICE CALL MADE TO STERIS. THE SERVICE CALL WAS MADE ONLY AFTER THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STR 60" CENTURY HC DOMESTIC HINGE STERILIZER FLE STERIS CORPORATION-ERIE 1112331 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention