BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS HAND CONTROLLED CURVED SHEA

    MDR report key: 1121891 · Received August 13, 2008

    Report

    Report Number
    1527736-2008-03931
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Report Date
    June 4, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 8/13/2008. EVAL 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 WILL STOP ACTIVATING, AND EITHER EMITS A SOLID TONE OR DISPLAY AN INSTRUMENT ERROR CODE 5 ON THE GENERATOR DISPLAY WHEN THE BLADE BECOMES DAMAGED. 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. THE IDENTIFIED BLADE DAMAGE MAY HAVE OCCURRED 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." 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 INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE MFG RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLECTOMY PROCEDURE, THE INSTRUMENT BECAME UNOPERATIONAL AFTER 2 HRS OF USE. CLEANING, DISASSEMBLING AND REASSEMBLING OF THE INSTRUMENT DID NOT SOLVE THE ISSUE. THE CASE WAS COMPLETED BY USING ANOTHER DEVICE. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS HAND CONTROLLED CURVED SHEA GEI ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA E4K20D

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR