BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) PISTOL GRIP 36CM - 15MM ACTIVE

    MDR report key: 1822181 · Received October 9, 2007

    Report

    Report Number
    1527736-2007-06703
    Event Type
    Malfunction
    Date Received
    October 9, 2007
    Report Date
    August 23, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC (CINCINNATI)
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: DEVICE A WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND MISSING. THE REMAINING BLADE PORTION HAD SCRATCHES. THIS BLADE TIP PORTION MAY HAVE BROKEN OFF OF THE DEVICE DURING TRANSPORT TO OUR DECONTAMINATION FACILITY OR FROM OUR DECONTAMINATION TO THE ANALYSIS SITE. THE REPORTED COMPLAINT WAS ACTIVATION ISSUES. DEVICE B WAS RETURNED WITH THE BLADE SCRATCHED AND CRACKED. DUE TO THE DAMAGE TO THE BLADE, IT WAS CONFIRMED THAT THE DEVICE WAS NON-FUNCTIONAL. THE DEVICE WAS TESTED WITH A GENERATOR AND AN ERROR CODE 5 WAS NOTED. BLADE DAMAGE MAY OCCUR FROM EXTERNAL CONTACT DURING PRE-OP OR GENERAL USE. IN ADDITION, MINOR BLADE DAMAGE MAY INCREASE IN SEVERITY DURING SUBSEQUENT ACTIVATIONS, AND MAY RESULT IN BLADE "LOCKOUT" LATER IN THE PROCEDURE. THEREFORE, THE INSTRUCTIONAL INSERT STATES: "AVOID ACCIDENTAL CONTACT WITH ALL METAL OR PLASTIC INSTRUMENTS OR OBJECTS WHEN THE INSTRUMENT IS ACTIVATED. CONTACT WITH STAPLES, CLIPS OR OTHER INSTRUMENTS WHILE THE INSTRUMENT IS ACTIVATED MAY RESULT IN CRACKED OR BROKEN BLADES, WHICH MAY BE IDENTIFIED BY GENERATOR SOLID TONE OR INSTRUMENT ERROR." WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THERE WAS NO FUNCTION AFTER A SHORT PERIOD OF TIME. TOOK A NEW INSTRUMENT TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) PISTOL GRIP 36CM - 15MM ACTIVE GEI ETHICON ENDO-SURGERY, INC (CINCINNATI) NA C4E892

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR