BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, BLADE 1" COATED

    MDR report key: 8617653 · Received May 16, 2019

    Report

    Report Number
    1060680-2019-00007
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    April 16, 2019
    Report Date
    August 9, 2019
    Manufacturer
    MODERN MEDICAL EQUIPMENT MANUFACTURING LTD.
    Product Code
    HGI
    UDI-DI
    50749756136018
    PMA / PMN Number
    K952030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE: THE ELECTRODE IS SUPPLIED TO DEROYAL BY MODERN MEDICAL EQUIPMENT. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) AS WELL AS RETURNED SAMPLES WERE SENT TO MODERN MEDICAL FOR EVALUATION. THE SUPPLIER PERFORMED TESTING ON RETAINED AND RETURNED SAMPLES AND WAS UNABLE TO REPEAT THE REPORTED FAILURE. ALL SAMPLES PERFORMED WELL AND MET SPECIFICATION. IN ITS SCAR RESPONSE, MODERN MEDICAL STATED IT WAS UNABLE TO CONFIRM THE COMPLAINT AND THEREFORE DETERMINE A ROOT CAUSE. THE POSSIBLE ROOT CAUSE MAY BE A MECHANICAL PUNCTURE OF THE BLADE SHEATH WHEN THE SHEATH IS STRETCHED TO COVER THE TIP. CORRECTIVE ACTION: IN ITS SCAR RESPONSE, MODERN MEDICAL STATED IT WAS UNABLE TO CONFIRM THE REPORTED ISSUE AND DETERMINE A ROOT CAUSE. THEREFORE, NO CORRECTIVE ACTION HAS BEEN TAKEN. INVESTIGATION SUMMARY AN INTERNAL COMPLAINT (B)(4) WAS RECEIVED FOR AN ELECTRODE (PART 88-000M13C, LOT 44748512) STATING THAT THE SHEATH OF THE BLADE MELTED DURING USE. A DEFECTIVE SAMPLE INITIALLY WAS REPORTED TO BE AVAILABLE FOR RETURN. ONE RETURNED SAMPLE WAS RECEIVED MAY 1, 2019 AND SHIPPED TO THE SUPPLIER FOR EVALUATION. THE COMPLAINT INVESTIGATOR REVIEWED THE WORK ORDER FOR POSSIBLE DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. LOT MAPPING IDENTIFIED THAT THE RAW MATERIAL ELECTRODE IS SUPPLIED TO DEROYAL BY MODERN MEDICAL EQUIPMENT. THE 2016-2018 SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) AND SUPPLIER NOTIFICATION LETTER LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS. SIMILAR COMPLAINTS WERE IDENTIFIED, AND A SCAR WAS ISSUED TO MODERN MEDICAL. A RESPONSE WAS RECEIVED AND ACCEPTED JUNE 6, 2019, BY DEROYAL PERSONNEL. BETWEEN JANUARY 2017 AND APRIL 2019, DEROYAL HAS SOLD (B)(4) CASES OF THE FINISHED GOOD. FIVE SIMILAR COMPLAINTS WERE IDENTIFIED. THIS IS A COMPLAINT-TO-SALES RATIO OF (B)(4). THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    THE SHEATH OF THE ELECTRODE BLADE MELTED TWO SEPARATE TIMES DURING SEPARATE SURGERIES.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (B)(4)WAS RECEIVED FOR AN ELECTRODE (PART 88-000M13C, LOT 44748512) STATING THAT THE SHEATH OF THE BLADE MELTED DURING USE. A DEFECTIVE SAMPLE INITIALLY WAS REPORTED TO BE AVAILABLE FOR RETURN. HOWEVER, AS OF THE DATE OF THIS REPORT, THAT SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. THE COMPLAINT INVESTIGATOR REVIEWED THE WORK ORDER FOR POSSIBLE DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. LOT MAPPING IDENTIFIED THAT THE RAW MATERIAL ELECTRODE IS SUPPLIED TO DEROYAL BY MODERN MEDICAL EQUIPMENT. THE 2016-2018 SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) AND SUPPLIER NOTIFICATION LETTER LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS. SIMILAR COMPLAINTS WERE IDENTIFIED, AND A SCAR WAS ISSUED TO MODERN MEDICAL. AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. BETWEEN JANUARY 2017 AND APRIL 2019, DEROYAL HAS SOLD 1,051 CASES OF THE FINISHED GOOD. FIVE SIMILAR COMPLAINTS WERE IDENTIFIED. THIS IS A COMPLAINT-TO-SALES RATIO OF 0.004757 OR 0.476%. THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE SHEATH OF THE ELECTRODE BLADE MELTED TWO SEPARATE TIMES DURING SEPARATE SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407970 ELECTRODE, BLADE 1" COATED ELECTROCAUTERY, GYNECOLOGIC HGI MODERN MEDICAL EQUIPMENT MANUFACTURING LTD. 88-000M13C 44748512 50749756136018

    Patients

    Seq Age Sex Outcome Treatment
    1