BEUDAMED
    FDA Adverse Event Other Summary report: N

    WASP

    MDR report key: 3410538 · Received September 20, 2013

    Report

    Report Number
    3002444944-2013-00003
    Event Type
    Other
    Date Received
    September 20, 2013
    Date of Event
    August 22, 2013
    Report Date
    September 18, 2013
    Manufacturer
    COPAN ITALIA SPA
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS PROCESSED AS (B)(4) PROCEDURE AND THE INVESTIGATION AND MDR EVALUATION HAS BEEN STARTED. THE INCIDENT WITH THE MACHINE WAS CAUSED BY ACCIDENTALLY TOUCHING OF A HOT SURFACE INSIDE THE MACHINE BY THE OPERATOR. THE HOT SURFACE WAS INDIVIDUATED AS THE INCINERATOR EXTERNAL SIDE. THE INCINERATOR IS PRESUMED TO BE HOT BECAUSE ITS FUNCTION AS STERILIZER. THE INCINERATOR IS LOCATED INTERNALLY IN THE WASP MACHINE AND IT IS IDENTIFIED AS A HOT SURFACE BY THE WARNING SYMBOL LABELING. THE INCINERATOR IS REACHABLE FROM THE USER ONLY WHEN THE MACHINE IS STOPPED AND IN EMERGENCY STATE AND ONLY ACCIDENTAL CONTACT WITH THE HOT SURFACE COULD BE POSSIBLE. THE OPERATOR WAS INSTRUCTED TO NOT PASS OVER THE INCINERATOR AREA. TESTING AT THE LABORATORY SIDE BY (B)(4) TECHNICAL SUPPORT VERIFIED THAT NOT ABNORMAL SITUATION WAS IN THE MACHINE. A CAPA WAS OPENED IN ORDER TO REVISE THE USER MANUAL ADDING MORE WARNINGS ABOUT THE ACCESS TO THE AREA CLOSEST TO THE INCINERATOR.

    Description of Event or Problem · 1

    THE WASP IS AN AUTOMATIC EQUIPMENT FOR THE PLANTING AND STREAKING OF CLINICAL SPECIMENS. DURING THE ORDINARY MAINTENANCE OF THE WASP MACHINE S/N: (B)(4) INSTALLED IN THE (B)(6) HOSPITAL, THE OPERATOR ACCIDENTALLY TOUCHED THE HOT SURFACE OF THE EXTERNAL SIDE OF THE INCINERATOR CAUSING A RUBESCENCE IN HIS ARM. THE INCINERATOR IS USED FOR THE LOOP STERILIZATION AND IT IS LOCATED INTERNALLY TO THE WASP VISIBLY IDENTIFIED BY THE HOT SURFACE WARNING SYMBOL LABELING. NO MEDICAL INTERVENTION WAS REQUIRED AND NO EVIDENCE OF THE INJURY REMAINED. THE INCIDENT HAPPENED DURING THE OPERATOR TRAINING AND DESPITE OF TRAINER RECOMMENDATION TO NOT PASS OVER THE INCINERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476529 WASP JTC COPAN ITALIA SPA W086

    Patients

    Seq Age Sex Outcome Treatment
    1