BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO STERNAL SAW II

    MDR report key: 2623908 · Received May 22, 2012

    Report

    Report Number
    1828100-2012-00522
    Event Type
    Malfunction
    Date Received
    May 22, 2012
    Date of Event
    June 4, 2009
    Report Date
    June 4, 2009
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    GFA
    PMA / PMN Number
    K935391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAW WAS RETURNED TO TERUMO FOR INVESTIGATION. IT WAS CONFIRMED THAT THE STERNAL SAW BLADE PROTECTOR WAS BROKEN DUE TO USER MISHANDLING. THE SAW WAS REPAIRED AND RETURNED TO THE CUSTOMER. THIS REPORT IS BEING SUBMITTED TO THE FDA AS A RESULT OF A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADE BROKE OFF ON THE STERNAL SAW. A BACKUP SAW WAS USED FOR SURGERY. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO STERNAL SAW II GFA TERUMO CARDIOVASCULAR SYSTEM CORP 6090

    Patients

    Seq Age Sex Outcome Treatment
    1