BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERFAS ENERGY SUPER 90-S

    MDR report key: 2220171 · Received August 15, 2011

    Report

    Report Number
    2648666-2011-00194
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE AFFECTED PRODUCT/LOT NUMBER COMBINATION WAS CONDUCTED. NO DISCREPANCIES WERE OBSERVED. THE NONCONFORMANCE HISTORY OF THE PRODUCT/PART NUMBER COMBINATION WAS REVIEWED. THERE WERE NO DISCREPANCIES RELATIVE TO THE REPORTED FAILURE MODE. THE PRODUCT WAS SUBJECTED TO VISUAL INSPECTION. PART OF THE CERAMIC TIP WAS STILL ATTACHED TO THE PRODUCT. THE OTHER HALF, INCLUDING THE ELECTRODE, WAS MISSING. THE LUMEN AND SHAFT OF THE PRODUCT WERE BOTH BENT. THIS INDICATES THAT THE PRODUCT WAS BENT INAPPROPRIATELY DURING USE. NO OTHER DEFECTS WERE OBSERVED. THE PRODUCT WAS CONNECTED TO A PROGRAMMER BOX AND THE E-PROM WAS CHECKED. NO ERROR CODES WERE OBSERVED. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED FAILURE, BASED ON THE ARTIFACTS OBSERVED ON THE RETURNED PRODUCT, CAN BE TRACED TO THE APPLICATION OF EXCESS FORCE DURING USE. THE IFU FOR THE PRODUCT CAUTIONS AGAINST THE USE OF EXCESS FORCE WHEN INSERTION OR REMOVING THE PRODUCT FROM AN OBSTRUCTED PASSAGEWAY. IN SUM, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ARTHROSCOPIC CASE, THE CERAMIC TIP OF THE UNIT BROKE OFF AND SHOT INTO THE JOINT OF THE PT. IT WAS FURTHER REPORTED THAT THE METAL TIP DETACHED FROM THE CERAMIC TIP THAT HAD BROKEN OFF. THE CASE WAS DELAYED FOR APPROX 3 MINUTES AS THE UNIT WAS REPLACED. IT WAS FURTHER REPORTED THAT THE CASE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTS OF ANY ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERFAS ENERGY SUPER 90-S PROBE GEI STRYKER ENDOSCOPY PUERTO RICO 11196AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK