BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5-POLE SPRING ARM AC 2000 15-21 KG

    MDR report key: 3073687 · Received April 23, 2013

    Report

    Report Number
    0002031963-2013-00023
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    STRYKER-COMMUNICATIONS
    Product Code
    FSY
    PMA / PMN Number
    K060802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE REDUCER RING FELL DURING A PROCEDURE, HOWEVER, THE ACCOUNT DECLINED TO PROVIDE ANY PATIENT INFORMATION. AS A RESULT, NO PATIENT INFORMATION IS KNOWN. THE CATALOG NUMBER PROVIDED IS FOR THE SPRING ARM WHICH HOUSED THE ELBOW COVER THAT WAS REPORTEDLY INVOLVED IN THIS EVENT. THE ACTUAL DEVICE WAS EVALUATED IN THE FIELD ON (B)(4) 2013. THE ACTUAL DEVICE WAS REPAIRED AT THE ACCOUNT ON (B)(4) 2013. ON (B)(6) 2013 A STRYKER FIELD SERVICE TECHNICIAN WENT TO THE CUSTOMER SITE AND REPORTED THAT THE ELBOW COVER WAS MISSING FROM THE SURGICAL LIGHT SPRING ARM AND THAT THE ACCOUNT CONFIRMED IT FELL. ON (B)(4) 2013 THE SAME SERVICE TECHNICIAN REPLACED THE MISSING ELBOW COVER. THE ROOT CAUSE FOR THIS EVENT IS UNKNOWN, HOWEVER, IT WAS REPORTED BY THE STRYKER SERVICE TECHNICIAN THAT THE COVER COULD HAVE FALLEN AFTER HITTING ANOTHER PIECE OF EQUIPMENT IN THE ROOM. IN THE (B)(4) VISIT TO THE ACCOUNT, THE ELBOW COVER ON THE SURGICAL LIGHT SPRING ARM WAS REPLACED WITH A NEW ONE. THERE WAS NO REPORT OF ANY ADVERSE CONSEQUENCES TO THE PATIENT OR CAREGIVER IN THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ELBOW COVER ON A SURGICAL LIGHT SPRING ARM ALLEGEDLY FELL OFF DURING A PROCEDURE, BUT DID NOT STRIKE ANYONE IN THE ROOM. THERE WAS NO ADVERSE CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173354 5-POLE SPRING ARM AC 2000 15-21 KG VISUM LED SURGICAL LIGHT FSY STRYKER-COMMUNICATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1