BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTOBASE RETRACTOR RACK

    MDR report key: 1001284 · Received February 15, 2008

    Report

    Report Number
    2135394-2008-00008
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 17, 2008
    Report Date
    January 17, 2008
    Manufacturer
    MEDTRONIC CARDIAC SURGERY TECHNOLOGIES
    Product Code
    DWS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: REASON FOR RETURN WAS CONFIRMED. VISUAL INSPECTION WAS PERFORMED WITH THE AID OF ANDREW OLSON. INSPECTION SHOWS A DEEP WEAR MARK SCRATCH ON THE RETRACTOR SIDE RAIL. IN ADDITION, WHEN OPENING THE RETRACTOR, WITH SLIGHT PRESSURE APPLIED, SOME GRINDING WAS NOTED. THIS GRINDING CAUSED SMALL METAL SHAVING TO FALL FROM THE RETRACTOR. FURTHER INSPECTION SHOWS SOME GALLING IN THE HANDLE PORTION OF THE RETRACTOR. CONCLUSION: REDUCED PERFORMANCE OF THE DEVICE OCCURRED AND IS RELATED TO THE EVENT. REVIEW OF COMPLAINTS NOTES NO SIMILAR REPORTED INCIDENTS, SUGGESTING THIS CASE TO BE AN ISOLATED OCCURRENCE. MEDTRONIC CONTINUES TO MONITOR FIELD PERFORMANCE TO DETECT SIMILAR EVENT. NO ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING A CORONARY ARTERY BYPASS CASE, RESISTANCE WAS NOTED WHEN TRYING TO CRANK OPEN THE PATIENT'S CHEST WITH THIS RETRACTOR. IT WAS REPORTED THAT METAL WAS VISIBLY SHAVING OFF OF THE DEVICE. THE DEVICE WAS REMOVED FORM THE PATIENT'S CHEST, AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE SURGEON REMEMBERED THAT THE DEVICE HAD BEEN DIFFICULT TO OPEN THE LAST TIME IT HAD BEEN USED. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTOBASE RETRACTOR RACK DWS MEDTRONIC CARDIAC SURGERY TECHNOLOGIES 28701 0307034

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other