BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENDEVAC W/ COATED BLADE, 10FT TUBING, HOLS

    MDR report key: 4752139 · Received May 5, 2015

    Report

    Report Number
    2320762-2015-00012
    Event Type
    Malfunction
    Date Received
    May 5, 2015
    Date of Event
    March 27, 2014
    Report Date
    May 1, 2015
    Manufacturer
    IC MEDICAL INC
    Product Code
    GEI
    PMA / PMN Number
    K944265
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE QFI REPORT WAS REVIEWED TO OBTAIN THE SALES AND SIMILAR COMPLAINT INFO. DEROYAL HAS SOLD (B)(4) CASES OF THE FINISHED GOOD FROM 2012 TO 2014. THE REPORTING CUSTOMER FILED TWO REPORTS FOR THE ISSUE DUE TO TWO DIFFERENT LOT NUMBERS IDENTIFIED. RAW MATERIAL 45-00224, LOT NUMBERS 5141 AND 5127 WERE UTILIZED WITHIN THE FINISHED GOOD LOT NUMBER. THE RAW MATERIAL IS A VENDOR SUPPLIED PROD AND SCAR2014-169KJG HAS BEEN ISSUED TO THE VENDOR. THE SAMPLE WAS REC'D AND CONSISTED OF PROD THAT WAS UTILIZED (CONTAINED WITHIN A BIOHAZARD BAG) AND REPRESENTATIVE PROD THAT WAS STILL WITHIN THE DEROYAL STERILE POUCHES. THE SAMPLES WERE FORWARDED TO THE VENDOR FOR EVAL AND TESTING. THE QC COMPLAINT SPECIALIST F/U WITH THE VENDOR ON 4/15/2014 TO ALERT THEM TO THE APPROACHING SCAR DUE DATE. WITHIN THE SCAR RESPONSE IT WAS DETAILED THAT THE PROD WAS TESTED UTILIZING THE ELECTRODE THAT WAS UTILIZED WHEN THE REPORTED ISSUE OCCURRED. THE VENDOR RESPONDED STATING: "DURING EVALUATION OF PEN EVACS, ESU GENERATOR FORCE 4B WAS USED, WITH SETTINGS STARTING AT 10 WATTS FOR CUT AND COAG AND GOING UP TO 30 WATTS FOR BOTH CUT AND COAG." (EMAIL (B)(6) "2104"). IN ADDITION, THE VENDOR SUPPLIED A COPY OF THEIR IFU REFERENCED WITHIN THE SCAR RESPONSE. THE IFU IS IDENTIFIED IN THE 001-0207 PENEVAC. THE VENDOR'S IFU WAS SUPPLIED TO DEROYAL'S MARKETING AND REGULATORY DEPARTMENT BY THE QC COMPLAINT SPECIALIST ON (B)(4) 2014. ADD'L COMMUNICATION WAS REC'D FROM THE VENDOR ON 5/8/2014, DETAILING THE PROD WAS TESTED WITH THE RETURNED BLADE AND FUNCTIONED WITHIN SPEC. THE VENDOR'S IFU IS NOT INCLUDED WITHIN THE FINISHED GOOD PROD RELEASED BY DEROYAL. DEROYAL INCLUDES IFU, PART NUMBER 45-00233G. DEROYAL ADDRESSES THE INSERTION OF THE ELECTRODE UNDER THE DIRECTIONS FOR USE, NUMBER 4. INSERT THE ELECTRODE INTO THE EXTENDEVAC BODY, ADJUST TO THE DESIRED LENGTH AND TIGHTEN THE LOCKING RING ON THE ELECTRODE 5. NOTE: WHEN THE LOCKING RING IS SECURE, THE ELECTRODE CAN STILL BE ROTATED TO THE DESIRED ORIENTATION WITHOUT LOOSENING THE RING. TO CHANGE THE LENGTH OF THE TELESCOPING TIP, YOU WILL STILL HAVE TO LOOSEN THE RING. CORRECTION: REPLACEMENTS WERE PROVIDED ON ORDER#(B)(4) BUT THE REPORTING CUSTOMER REC'D THE SAME LOT NUMBER AS REPORTED AND REQUESTED AN ALTERNATE LOT NUMBER BE PROVIDED. AN ALTERNATE LOT NUMBER WAS PROVIDED ON ORDER#(B)(4). ROOT CAUSE ANALYSIS: SCAR: WHEN THE END USER REPLACED THE ELECTRODE WAS NOT PROPERLY INSERTED INTO THE ELECTRODE SOCKET WHICH IMPEDED PRODUCT FUNCTION. WHEN THE PROD WAS TESTED USING AN ELECTRODE FROM AN UNUSED PROD, IT FUNCTIONED WITHIN SPEC WITHOUT ANY ISSUES. ADD'L INFO EMAIL 5/8/2014: THE PROD WAS TESTED WITH THE RETURNED BLADE AND WAS FOUND TO BE FUNCTIONING WITHIN SPEC. DEROYAL: THE CUSTOMER'S REPORT OF A MALFUNCTIONING PENCIL IS UNABLE TO BE CONFIRMED AS A DEVICE RELATED ISSUE. THE RETURNED PROD WAS FORWARDED TO IC MEDICAL FOR EVAL. THE PROD REVIEW FOUND THE ELECTRODE INSTALLED BY THE REPORTING CUSTOMER WAS NOT PROPERLY SECURED WITHIN THE DEVICE. TESTING WAS PERFORMED UTILIZING THE REPLACED ELECTRODE AND A DEROYAL SUPPLIED ELECTRODE. THE PROD FUNCTIONED AS INTENDED. CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: SCAR: NONE, WHEN THE PROD WAS TESTED USING AN ELECTRODE FROM AN UNUSED PRODM IT FUNCTIONED WITHIN SPEC, WITHOUT ANY PROBLEM. INSTRUCTION ON PROPER ELECTRODE REPLACEMENT LISTED UNDER IN IFU AND READS: INSERT NEW ELECTRODE INTO THE SOCKET INSIDE OF THE PENEVAC. MAKE SURE THAT THE ELECTRODE IS SECURELY INSERTED IN TO THE SOCKET. PREVENTIVE ACTION: SCAR: NONE. THIS REPORT IS BEING FILED DUE TO A RETROSPECTIVE REVIEW OF COMPLAINTS. THIS COMPLAINT HAS BEEN RE-OPENED FOR FURTHER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IN FURTHER INVESTIGATION PROVIDES INFO WHICH CHANGES THE CONTENT OF THIS REPORT.

    Description of Event or Problem · 1

    EMAIL FROM REP (B)(6) - I JUST REC'D AN URGENT CALL FROM THE BELOW SURGERY CTR INDICATING THEY ARE HAVING PROBLEMS WITH EXTENDEVAC 88-000702 NOT RESPONDING/ACTIVATING WHEN THEY PUSH THE BUTTONS. THEY HAVE TWO DIFFERENT LOT NUMBERS 32654105 AND 33128393. THIS ACCOUNT HAS USED THESE PENCILS FOR QUITE SOME TIME SO I DON'T BELIEVE IT IS A TRAINING ISSUE. THE DOCTOR IS SUPER FRUSTRATED AND WANTS TO STOP USING. SURGERY STAFF LOVES IT FOR THE SMOKE FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292542 EXTENDEVAC W/ COATED BLADE, 10FT TUBING, HOLS ELECTROSURGICAL, CUTTING & COAGULATI GEI IC MEDICAL INC 33128393

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention