BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS LONG 5MM CURVED SHEARS

    MDR report key: 1761351 · Received July 19, 2010

    Report

    Report Number
    3005075853-2010-04017
    Event Type
    Malfunction
    Date Received
    July 19, 2010
    Date of Event
    June 18, 2010
    Report Date
    June 30, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS SHOWED THAT THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND NOT RETURNED WITH THE DEVICE. THE REMAINING BLADE PORTION WAS SCRATCHED. THE DEVICE WAS ACTIVATED WITH THE GENERATOR AND AN ERROR CODE 5 WAS DISPLAYED. PROBABLE CAUSES OF BLADE DAMAGE, INCLUDING BREAKAGE, ARE EXTERNAL CONTACT DURING PRE-OP OR GENERAL USE, BLADE CONTACT WITH OTHER DEVICES, STAPLES OR CLIPS DURING THE PROCEDURE OR USING ANY MEANS OTHER THAN THE BLADE WRENCH TO ATTACH OR DETACH THE BLADE. ONCE MINOR BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY INCREASE DAMAGE SEVERITY AND RESULT IN AN ERROR CODE 5 OR BLADE ¿LOCKOUT¿ LATER IN THE PROCEDURE, AND CONTINUED USAGE CAN RESULT IN A BROKEN BLADE THE HARMONIC BLADES ARE MADE OF TITANIUM. THE HARMONIC BLADE WILL STOP ACTIVATING, AND EITHER EMIT A SOLID TONE AND/OR DISPLAY AN INSTRUMENT ERROR CODE WHEN THE BLADE HAS BECOME CRACKED (BUT NOT SCRATCHED, NICKED OR GOUGED). ONCE THE BLADE IS CRACKED, IT IS SUSCEPTIBLE TO BREAKING OFF DUE TO CONTINUED ATTEMPTS TO ACTIVATE OR FROM PHYSICAL CONTACT. ONCE THE BLADE TIP IS BROKEN OFF, IT MAY BE POSSIBLE FOR THE DEVICE TO BE ACTIVATED WITHOUT AN ERROR CODE. BLADE DAMAGE IS CAUSED BY CONTACTING AN ACTIVE BLADE WITH OTHER SURGICAL DEVICES, STAPLES OR CLIPS DURING THE PROCEDURE OR USING ANY MEANS OTHER THAN THE BLADE WRENCH TO ATTACH OR DETACH THE BLADE. ONCE BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY RESULT IN FATIGUE FAILURE INITIATING AT THE ORIGINAL DAMAGE LOCATION, WHICH CAN RESULT IN THE BLADE TIP BREAKING OFF AS DESCRIBED ABOVE.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ISSUE WITH THEIR METER. UPON INVESTIGATION, THE METER WAS FOUND TO EXHIBIT THE MEMORY OVERWRITE MALFUNCTION. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE ACTIVE BLADE WAS BROKEN IN THE ABDOMEN OF THE PATIENT. THEY COULD NOT RETRIEVE THE BLADE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS LONG 5MM CURVED SHEARS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK F4MU19

    Patients

    Seq Age Sex Outcome Treatment
    1