BEUDAMED
    FDA Adverse Event Other Summary report: N

    E-Z CLEAN LAPAROSCOPIC ELECTRODE, L-WIRE

    MDR report key: 1456847 · Received August 14, 2009

    Report

    Report Number
    1721194-2009-00003
    Event Type
    Other
    Date Received
    August 14, 2009
    Date of Event
    July 21, 2009
    Report Date
    August 14, 2009
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS
    Product Code
    GEI
    PMA / PMN Number
    K913281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: OUR INVESTIGATION REVEALED EXCESSIVE COATING WAS APPLIED TO THE TIP CAUSING THE COATING TO CRACK DURING THE CURING PROCESS AND MAKING IT MORE SUSCEPTIBLE TO FLAKING DURING USE. A DHR REVIEW WAS PERFORMED WHICH REVEALED NO DEVIATIONS OR ABNORMALITIES DURING THE PRODUCTION OF THIS PRODUCT. THIS IS A VALIDATED PROCESS THAT INVOLVES 100% VISUAL INSPECTION FOR DETECTION OF THIS FAILURE MODE. SUBSEQUENT INSPECTION OF SAMPLES OF THIS LOT AND MEGADYNE'S REMAINING MULTI-LOT INVENTORY, PRE- AND POST-STERILIZATION, DO NOT MANIFEST FURTHER FAILURES OF THIS NATURE AND WE HAVE NOT RECEIVED FURTHER FIELD REPORTS. TESTING PER INTERNATIONAL STANDARDS WAS CONDUCTED DURING THE DESIGN PHASE OF THIS PRODUCT AND INCLUDED THE EVAL OF THE PROPERTIES OF THIS COATING (DETERIORATION, FLAKING, PULVERIZATION, ETC.) AND ITS IMPACT ON THE SAFETY AND PERFORMANCE OF THE DEVICE. THE PRODUCT MEETS OR EXCEEDS ALL APPLICABLE STANDARDS, INCLUDING STANDARDS FOR BIOCOMPATIBILITY. THE RISK(S) ASSOCIATED WITH THIS FAILURE MODE WERE IDENTIFIED IN THE ORIGINAL RISK MANAGEMENT PROCESS, CONDUCTED PER ISO 14971, AND THE FAILURE OCCURS WITH LESS FREQUENCY AND SEVERITY THAN ORIGINALLY DEFINED. MEGADYNE HAS DETERMINED THE MALFUNCTION IS NOT REPORTABLE SINCE IT DID NOT INVOLVE DEATH OR INJURY OR INTERVENTION TO PRECLUDE DEATH OR INJURY AND THE RISK TO PUBLIC HEALTH IS REMOTE. THIS REPORT IS PROVIDED AS INFO ONLY.

    Description of Event or Problem · 1

    DURING A LAP CHOLE THE TEFLON COATING ON THE COAG TIP CHIPPED OFF/DELAMINATED INTO THE PT. A POWER SETTING OR BETWEEN 23-24 WATTS WAS USED. THIS HAS BEEN OUR THIRD PROCEDURE WITH THIS PROBLEM, ALL HAVE BEEN THE SAME LOT#. THIS LOT HAS BEEN REMOVED FROM THE OR AND REPLACED. THERE WAS NO PT'S INJURY. MANUFACTURER RESPONSE (AS PER REPORTER) FOR ESU L-TIP COAG HANDPIECE, MEGADYNE E-Z CLEAN. MANUFACTURER PROVIDED RGA FOR PRODUCT RETURN EVAL. DID THIS EVENT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE. NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E-Z CLEAN LAPAROSCOPIC ELECTRODE, L-WIRE LAPAROSCOPIC ELECTRODE, 33 CM, L-WIRE GEI MEGADYNE MEDICAL PRODUCTS 0100 90973

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR