BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO STERNAL SAW II

    MDR report key: 2867679 · Received December 7, 2012

    Report

    Report Number
    1828100-2012-01516
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    August 20, 2012
    Report Date
    November 13, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GFA
    PMA / PMN Number
    K935391
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, THE HOSPITAL HAS NO PLANS TO RETURN THE SAW OR SAW BLADE. TERUMO CARDIOVASCULAR SYSTEMS BECAME AWARE OF THE EVENT THROUGH MEDWATCH (B)(4). CLINICAL REVIEW REVEALED: THE PROCEDURE WAS A RE-OPERATION FOR A RV TO PA CONDUIT CHANGE. THE SARNS STERNAL SAW II WAS USED FOR THIS REPEAT STERNOTOMY, EVEN THOUGH THE SAW IS CONTRAINDICATED FOR THIS PROCESS. THE CONTRAINDICATION IS DESCRIBED ON PAGE 4 OF THE OPERATORS MANUAL. THE SCRUB NURSE STATED THAT A SARNS SAW BLADE WAS USED IN THIS PROCEDURE. THE SCRUB NURSE INSERTED THE DISPOSABLE BLADE INTO THE SAW DURING SET-UP OF THE SURGICAL INSTRUMENTS. SHE STATED THAT AFTER THE BLADE WAS INSERTED, SHE CHECKED THE OPERATION OF THE SAW AND THE INTEGRITY OF THE BLADE CONNECTION TWICE BEFORE USED BY THE CV SURGEON. INVESTIGATION IS IN PROCESS, BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A SURGICAL PROCEDURE, THE BLADE FROM THE STERNAL SAW BECAME SEPARATED FROM THE SAW AND CAUSED A SMALL AND SUPERFICIAL TEAR OF THE RIGHT VENTRICLE (RV) TO PULMONARY ARTERY (PA) CONDUIT. THE TEAR RESULTED IN A VERY SMALL LOSS OF BLOOD, 25ML, AND REQUIRED ONE SUTURE TO STOP THE BLEEDING. AS A RESULT, THE DEVICE WAS CHANGED OUT. THIS DELAYED THE PROCEDURE BY APPROXIMATELY FIVE MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO STERNAL SAW II GFA TERUMO CARDIOVASCULAR SYSTEMS CORP. 5590

    Patients

    Seq Age Sex Outcome Treatment
    1 Other