BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WASPLAB CONVEYOR

    MDR report key: 5229512 · Received November 17, 2015

    Report

    Report Number
    3009288740-2015-00001
    Event Type
    Malfunction
    Date Received
    November 17, 2015
    Date of Event
    July 29, 2015
    Report Date
    September 13, 2015
    Manufacturer
    COPAN WASP SRL
    Product Code
    JTC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CAPA WAS OPENED DUE TO THIS COMPLAINT AND AN INTERNAL INVESTIGATION WAS CONDUCTED. THE INCIDENT WAS CAUSED BY AN ACCIDENTAL SLIPPING OF THE OPERATOR HAND IN THE ROLLER POSITIONED IN THE END OF THE WASPLAB CONVEYOR. THE ACCIDENT OCCURRED DURING AN ATTEMPT TO MANUALLY CATCH A PLATE MOVING TOWARD THE TRASH UNLOADING POSITION. THE MANUAL PLATE REMOVAL IS NOT A NORMAL ROUTINE OPERATION ASKED TO THE OPERATOR, BUT THE PINCHING RISK ASSOCIATED TO MANUAL PLATE REMOVAL IS IDENTIFIED IN THE WASPLAB RISK ANALYSIS FILE. A SAFETY LABEL FOR THE PINCHING RISK IS PRESCRIBED AS A MITIGATION METHOD TO ALERT PEOPLE WORKING IN THE WASPLAB AREA. FROM THE INVESTIGATION IT WAS VERIFIED THAT THE EXPECTED PINCHING SAFETY LABEL WAS NOT PRESENT IN THIS WASPLAB CONVEYOR. AS AN IMMEDIATE ACTION THE SAFETY LABEL WAS STUCK ON (B)(6) WASPLAB CONVEYOR. IT WAS ALSO VERIFIED THAT NO OTHER WASPLAB INSTRUMENTS ALREADY RELEASED IN THE MARKET ARE AFFECTED BY THE SAME OR SIMILAR LABELLING LACK. THIS IS THE FIRST NOTIFICATION OF THIS TYPE OF EVENT THAT WE HAVE RECEIVED ON WASPLAB. NO ADVERSE PERMANENT MEDICAL CONSEQUENCES WERE REPORTED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ADDITIONAL INFORMATION RELATED TO THE FILE SUBMISSION: FROM THE LAST 9TH OF SEPTEMBER WE EXPERIENCED ISSUES WITH THE ((B)(4)).THESE PROBLEMS WERE CAUSED BY DIFFICULTIES IN THE IMPLEMENTATION OF THE SOFTWARE PREVENTING (B)(4) FROM SUBMITTING THIS FILE ON TIME.

    Description of Event or Problem · 1

    IN THE EARLY MORNING (AROUND 02:30) OF THE (B)(6), AN OPERATOR THAT WAS WORKING ON THE WASPLAB CONVEYOR TRACK (S/N (B)(4)) INSTALLED AT (B)(6) HOSPITAL, INJURED HER HAND WHILE SHE WAS TRYING TO CATCH A PLATE BEFORE TO BE RELEASED IN THE TRASH UNLOADING POSITION. THE (B)(6) THE SUPERVISOR OF THE LABORATORY INFORMED THE (B)(4) DISTRIBUTOR FAS (FIELD APPLICATION SPECIALIST) VISITING THE LABORATORY OF THE OCCURRED INJURY AND THE(B)(6) IT WAS REPORTED TO (B)(4) BY E-MAIL; THAT WAS FIRST COMMUNICATION TO THE MANUFACTURER. THE (B)(6) THE FAS WAS ABLE TO REACH AND TO TALK WITH THE INJURED OPERATOR WHO REPORTED THAT HER HAND SLIPPED TOO CLOSE TO THE END OF THE WASPLAB CONVEYOR BELT AND THE METAL ROLLER GRABBED HER PALM AND SUCKED IT IN BETWEEN IT AND THE METAL END PIECE. THE LINE STOPPED ON HER HAND AND SHE WAS ABLE TO PULL IT OUT. AS CONSEQUENCE SHE HAD A LARGE BRUISE AND BLOOD BLISTER INSTANTLY ON HER HAND. HER THUMB, INDEX FINGER AND WRIST WERE SWOLLEN AND ACHING. SHE WENT TO THE HOSPITAL: X-RAYS WERE TAKEN AND ACE WRAP TO HELP WITH THE SWELLING AND PAIN AND SHE HAD A CARE REGIMEN. AT THE (B)(6) THE HOSPITAL CLOSED HER CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759687 WASPLAB CONVEYOR LABORATORY CONVEYOR TRACK JTC COPAN WASP SRL W087-010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other