BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS HAND CONTROLLED CURVED SHEA

    MDR report key: 1250616 · Received November 14, 2008

    Report

    Report Number
    3005075853-2008-03056
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 22, 2008
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 11/14/2008. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE 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 GEN04 AND AN ERROR CODE 5 WAS NOTED. WHEN A BLADE HAS BEEN COMPROMISED, SCRATCHED OR CRACKED, THE TITANIUM METAL IS FATIGUED WHEN CONTINUALLY ENERGIZED AND THIS RESULTS IN THE BLADE FURTHER CRACKING AND POSSIBLY BREAKING OFF. DURING THE ANALYSIS PROCESS, THE BLADE WAS TESTED FOR SCRATCHES AND CRACKS AND THE BLADE BROKE OFF. POSSIBLE CAUSES FOR THIS TYPE OF BLADE DAMAGE EXTERNAL CONTACT DURING PRE-OP OR GENERAL USE SUCH AS ACCIDENTAL CONTACT WITH METAL OR PLASTIC INSTRUMENTS OR OBJECTS WHEN THE INSTRUMENT IS ACTIVATED. IN ADDITION, MINOR BLADE DAMAGE MAY INCREASE IN SEVERITY DURING SUBSEQUENT ACTIVATIONS, AND MAY RESULT IN BLADE "LOCKOUT" LATER IN THE PROCEDURE. CONTACT WITH STAPLES, CLIPS OR OTHER INSTRUMENTS WHILE THE INSTRUMENT IS ACTIVATED MAY RESULT N CRACKED OR BROKEN BLADES, WHICH MAY BE IDENTIFIED BY GENERATOR SOLID TONE OR INSTRUMENT ERROR. EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED PRIOR TO SHIPMENT, AND DAMAGE OF THIS MAGNITUDE WOULD HAVE BEEN DETECTED AT THIS PROCESS. 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. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP APPENDECTOMY, THERE WAS AN INSTRUMENT FAILURE CODE. THE SURGEON TIGHTENED THE INSTRUMENT ONE CLICK ONTO THE HAND PIECE AND STILL GOT A FAILURE CODE. THEY THEN TOOK THE INSTRUMENT APART FROM THE CORD/HAND PIECE. IT WAS TESTED TO MAKE SURE IT WAS OK AND IT WAS. THEY REPLACED THE INSTRUMENT BACK ONTO THE CORD AND STILL HAD THE FAILURE CODE. THEY FINALLY OPENED A NEW INSTRUMENT AND USED IT TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS HAND CONTROLLED CURVED SHEA GEI ETHICON ENDO-SURGERY, LLC NA E4M23L

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE