BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EYE SURGERY STRETCHER

    MDR report key: 2984167 · Received February 28, 2013

    Report

    Report Number
    0001831750-2013-01596
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    September 15, 2010
    Report Date
    September 13, 2012
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE SUBMITTED. IT HAS NOT BEEN DETERMINED AT THIS TIME IF THE UNIT WILL BE MADE AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE UNIT COULD NOT BE EVALUATED AND A CORRECTION/REPAIR TO THE UNIT COULD NOT BE PERFORMED OR CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO STRYKER THAT THE CUSTOMER ALLEGED THAT THE EYE SURGERY STRETCHER SUDDENLY DROPPED DURING A PROCEDURE. THE CUSTOMER FURTHER ALLEGED THAT, AS A RESULT OF THIS DROP, A PATIENT RECEIVED AN EYE WOUND FROM A SURGICAL NEEDLE. STRYKER WAS NOT AWARE OF THE EVENT UNTIL NEARLY TWO YEARS AFTER THE EVENT OCCURRED AND HAS NOT BEEN ABLE TO EVALUATE THE UNIT. THE PATIENT HAS CLAIMED THAT THIS IS THE RESULT OF USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO STRYKER THAT THE CUSTOMER ALLEGED THAT THE EYE SURGERY STRETCHER SUDDENLY DROPPED DURING A PROCEDURE. THE CUSTOMER FURTHER ALLEGED THAT, AS A RESULT OF THIS DROP, A PATIENT RECEIVED AN EYE WOUND FROM A SURGICAL NEEDLE. STRYKER WAS NOT AWARE OF THE EVENT UNTIL NEARLY TWO YEARS AFTER THE EVENT OCCURRED AND HAS NOT BEEN ABLE TO EVALUATE THE UNIT. THE PATIENT HAS CLAIMED THAT THIS IS THE RESULT OF USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86018 EYE SURGERY STRETCHER STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 1089

    Patients

    Seq Age Sex Outcome Treatment
    1