BEUDAMED
    FDA Adverse Event Summary report: N

    16" EAGLE GRAVITY STAGE 3

    MDR report key: 2231188 · Received September 1, 2011

    Report

    Report Number
    3005899764-2011-00017
    Date Received
    September 1, 2011
    Date of Event
    December 12, 2010
    Report Date
    September 1, 2011
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    PMA / PMN Number
    EXCEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS TECHNICIAN WENT ON-SITE BUT WAS UNABLE TO INSPECT THE STERILIZER AS IT HAD BEEN REMOVED FROM SERVICE DUE TO ITS AGE. THE STERILIZER WAS MANUFACTURED IN 1985 AND EXCEEDED ITS EXPECTED USEFUL LIFE. AT THE TIME OF THE REPORTED EVENT THE STERILIZER WAS MAINTAINED AND SERVICED BY THE USER FACILITY ENGINEERING DEPARTMENT. DURING THE COURSE OF THE INVESTIGATION THE USER FACILITY REPORTED THAT THE STERILIZER SUBJECT OF THIS EVENT WAS NOT PROPERLY MAINTAINED BY THEIR ENGINEERING STAFF. SPECIFICALLY IN REVIEW OF THE PREVENTATIVE MAINTENANCE RECORDS: THE EQUIPMENT PREVENTIVE MAINTENANCE GUIDE REQUIRES THE FOLLOWING (PP. 4-8) DURING EACH INSPECTION (6X/YEAR), "INSPECT DOOR FOR EASE OF OPERATION. INSPECT CONDITION OF DOOR GASKET FOR WEAR AND TEAR, REPLACE AS NECESSARY. INSPECT DOOR ALIGNMENT WITH END RING. LUBRICATE HINGE AND HINGE PINS." THE GUIDE FURTHER REQUIRES THE FOLLOWING THREE TIMES PER YEAR, "LUBRICATE BEARINGS AND DOOR POST. REMOVE HAND WHEEL AND DOOR COVER: INSPECT AND CLEAN INTERNAL PARTS, REPLACE IF NECESSARY. INSPECT DOOR LOCK MECHANISM FOR WEAR. LUBRICATE AND REBUILD DOOR LOCK MECHANISM. REINSTALL COVER AND HAND WHEEL." THE STERIS TECHNICIAN STATED THE MAINTENANCE OF THIS DEVICE DID NOT INCLUDE ALL THE REQUIRED DOOR ACTIVITIES. STERIS WILL REVIEW PROPER STERILIZER MAINTENANCE REQUIREMENTS WITH THE USER FACILITY.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AN OPERATOR EXPERIENCED DIFFICULTY WHEN ATTEMPTING TO OPEN THE STERILIZER DOOR AFTER A COMPLETED CYCLE. WHEN THE OPERATOR ATTEMPTED TO OPEN THE DOOR BY STANDING TO THE SIDE AND PULLING ON THE DOOR HAND WHEEL WITH BOTH HANDS, SHE INJURED HER RIGHT ELBOW. THE EMPLOYEE WENT TO AN URGENT CARE FACILITY WHERE SHE WAS DIAGNOSED WITH LATERAL EPICONDYLITIS. SHE UNDERWENT SURGERY AND PHYSICAL THERAPY TO REPAIR HER ELBOW LIGAMENT AND HAS SINCE RETURNED TO NORMAL WORK DUTIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 16" EAGLE GRAVITY STAGE 3 EAGLE GRAVITY STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other