BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI PWR DISPOSBL GRNDING PAD

    MDR report key: 1931835 · Received December 10, 2010

    Report

    Report Number
    1717344-2010-00919
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    October 5, 2010
    Report Date
    November 16, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: 12/09/2010. THE DGPHP PRODUCT SAMPLES WERE RETURNED FOR EVALUATION AS A RESULT OF IMPROPER IMPEDANCE READINGS DURING THE ABLATION PROCEDURE. HOWEVER, WHEN THE SAMPLES WERE EVALUATED, THEY WERE FOUND TO BE DEGRADED. THE INCIDENT SAMPLES WERE MANUFACTURED PRIOR TO CORRECTIVE ACTION. THE CONCOMITANT ACT1520 ELECTRODE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    INITIALLY THE CUSTOMER REPORTED THAT DURING AN ABLATION PROCEDURE, WHEN THE ON BUTTON WAS PRESSED TO TURN OUTPUT UP, THE IMPEDANCE WAS DISPLAYED AS 600. THE DOCTOR TRIED CONNECTING THE PAD TO THE GENERATOR WITHOUT AN EXTENSION CABLE BUT THE SITUATION WAS THE SAME. IT WAS FIXED AFTER THE TWO PADS WERE REPLACED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO PT INJURY. THE INCIDENT PAD SAMPLES WERE RETURNED FOR EVALUATION. EVALUATION FOUND BOTH PADS WERE DEGRADED AND DIDN'T' SHOW ANY RESISTANCE. TO MITIGATE THIS CONDITION THREE CORRECTIVE ACTIONS HAVE BEEN TAKEN TO IMPROVE THE RELIABILITY OF THE PAD. TWO DESIGN CHANGES WERE MADE TO IMPROVE THE FLEXURAL STRENGTH OF THE TAB AREA OF THE PAD: THE POLYESTER BACKING THICKNESS WAS INCREASED AND THE POLYESTER TAB, WHICH ACTED AS A STRESS CONCENTRATOR FOR FOIL CRACKING, WAS ELIMINATED. THE THIRD ACTION WAS TO ADD A SPECIFICATION TO THE DRAWING TO ASSURE PROPER GAP BETWEEN THE TERMINATION AND THE GEL, WHICH WILL REDUCE THE LIKELIHOOD FOR CORROSION OF THE FOIL. PHASE 2 CORRECTIVE ACTIONS HAVE BEEN TAKEN TO FURTHER IMPROVE THE RELIABILITY OF THE PAD. THE ALUMINUM LAYER THICKNESS IN THE POLYESTER-BACKED ALUMINUM FOIL WAS INCREASED. THE RADII ON THE FOIL LOCATED AT THE BASE OF THE TAB WERE INCREASED IN ORDER TO MITIGATE BENDING AT THIS STRESS POINT. THE FOAM TERMINAL COVER ON THE BACK SIDE OF THE ELECTRODE WAS EXTENDED FURTHER ONTO THE BACK OF THE PAD AND THIS END WAS CHANGED FROM A RECTANGULAR SHAPE TO A SEMI-CIRCLE TO MITIGATE BENDING AT THE TAB STRESS POINT. HOLES WERE PUNCHED INTO THE TABS ON BOTH THE FOAM BACKING AND FOIL LAYERS TO SERVE AS LOCATORS FOR THE CORD TERMINATION EYELET AND WASHER, EXTENDING THE DISTANCE BETWEEN THE HYDROGEL AND TERMINATION TO REDUCE GALVANIC CORROSION. THE CONFIGURATION OF THE RETURNED SAMPLES INDICATED THAT THEY WERE MANUFACTURED BEFORE CORRECTIVE ACTIONS WERE IMPLEMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI PWR DISPOSBL GRNDING PAD RF ABLATION GROUNDING PAD GEI COVIDIEN LP (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACT1520, LOT # 164591