BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFOGGER

    MDR report key: 4749173 · Received May 4, 2015

    Report

    Report Number
    1060680-2015-00022
    Event Type
    Malfunction
    Date Received
    May 4, 2015
    Date of Event
    April 2, 2015
    Report Date
    April 30, 2015
    Manufacturer
    DEROYAL INDUSTRIES
    Product Code
    KOG
    PMA / PMN Number
    K982465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE QFI REPORT WAS REVIEWED FOR IDENTIFICATION OF THE RAW MATERIAL AND RAW MATERIAL LOT NUMBERS THAT WERE CONTAINED WITHIN THE FINISHED GOOD AND LOT NUMBER REPORTED. THE FINISHED GOOD AND LOT NUMBER REPORTED CONTAIN RAW MATERIAL 040-4001 - PAD DEFOGGER LOT NUMBER 35954015 AND 35523418. THIS PRODUCT IS SUPPLIED BY (B)(4). THE 2013, 2014 AND 2015 QFI LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS. IT WAS CONFIRMED THAT FROM (B)(6) TO (B)(6) 2014, EIGHT COMPLAINTS WERE RECEIVED REPORTING THE ADHESIVE PAD IS ADHERING TO THE BACKING PAPER. AS A RESULT OF THESE COMPLAINTS, CORRECTIVE ACTIONS WERE TAKEN AT (B)(4) WHERE THE PAD IS MANUFACTURED. DURING THE INVESTIGATION, IT WAS CONFIRMED THAT THE IDENTIFIED RAW MATERIALS CONTAINED WITHIN THE FINISHED GOOD AND LOT NUMBER REPORTED WERE MANUFACTURED PRIOR TO ACTIONS TAKEN DUE TO THE COMPLAINTS RECEIVED IN 2014. THERE HAVE BEEN NO ADDITIONAL REPORTS RECEIVED IN WHICH THE ISSUE HAS REOCCURRED AFTER THE CORRECTIVE AND PREVENTIVE ACTIONS TAKEN. THE QC COMPLAINT SPECIALIST CONTACTED (B)(4) PROCESS MANAGER VIA EMAIL ON (B)(6) 2015 TO REQUEST IF ANY ADDITIONAL ACTIONS WOULD BE IDENTIFIED. WITHIN A RESPONSE RECEIVED ON THE SAME DAY, NO ADDITIONAL ACTIONS WERE IDENTIFIED. THE EMAIL REFERENCED WITHIN THE COMPLAINT WILL BE MAINTAINED AS PART OF THE QC COMPLAINT SPECIALIST EMAIL FILE. DEROYAL WILL CONTINUE TO TRACK AND TREND FOR THIS TYPE OF REPORT AND WILL RECOGNIZE IN THE FUTURE IF THE ISSUE TRANSITIONS FROM A RANDOM PART DEFECT TO A REOCCURRING ISSUE. CORRECTION: A REPLACEMENT HAS BEEN PROVIDED ON ORDER# (B)(4). ROOT CAUSE ANALYSIS: REPRESENTATIVE SAMPLES THAT WERE RETURNED BY THE REPORTING CUSTOMER WERE FOUND TO RELEASE PROPERLY AND DID NOT EXHIBIT THE FAILURE MODE REPORTED WHEN TESTED BY THE QC COMPLAINT SPECIALIST. THE ACTUAL SAMPLE IN WHICH THE ISSUE HAS OCCURRED WAS NOT RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE BASED OFF A PREVIOUS INVESTIGATION HAS BEEN IDENTIFIED AS FOLLOWS: "THE ADHESIVE PAD NOT RELEASING PROPERLY AND ADHERING TO THE RELEASE LINER IS DUE TO A KNOWLEDGE BASED ERROR BY THE OPERATOR DURING THE MANUFACTURING PROCESS OF THE DEFOGGER PAD. THE TENSION BEING PLACED ON THE GREEN ESTER FOAM WAS TOO GREAT DUE TO A CONTRIBUTING FACTOR OF THE SHAFT BEING UTILIZED ON THE MACHINE. AN ADDITIONAL FACTOR OF THE ADH DYE SCORING TOO DEEP WITHIN THE LINER WAS ALSO IDENTIFIED." CORRECTIVE AND/OR SYSTEMIC CORRECTION ACTION TAKEN: TO ADDRESS THE KNOWLEDGE BASED ERROR IDENTIFIED WITHIN THE INVESTIGATION PROCESS, THE MANUFACTURING FACILITY HAS OPTED TO RETRAIN ALL PERSONNEL THAT WOULD OPERATE THE MACHINE UTILIZED TO MANUFACTURE THE DEVICE. EVIDENCE OF THE RETRAINING IS CONTAINED WITHIN THE EMPLOYEE TASK TRAINING ATTACHMENT. IN ADDITION TO EMPLOYEE TRAINING, THE ADH DYE WAS SENT OUT FOR RE-TOOLING AND THE SPECIFICATION SHEET UPDATED TO PROVIDE ADDITIONAL WORK INSTRUCTIONS. REFER TO THE SPECIFICATIONS AND RE-TOOLING ATTACHMENT AS EVIDENCE. SINCE THE LOT NUMBER HAS BEEN IDENTIFIED AS BEING MANUFACTURED PRIOR TO THE ACTIONS TAKEN PREVIOUSLY, IT HAS BEEN DETERMINED THAT NO ADDITIONAL ACTIONS WILL BE NECESSARY. PREVENTIVE ACTION: THE SPECIFICATION SHEET FOR (B)(4), PART NUMBER 040-4001, WAS UPDATED AND APPROVED ON 09/05/2014. INSTRUCTIONS WERE ADDED TO STATE, "DO NOT RUN GREEN ESTER FOAM ON A 3" SHAFT." SINCE THE LOT NUMBER HAS BEEN IDENTIFIED AS BEING MANUFACTURED PRIOR TO THE ACTIONS IDENTIFIED PREVIOUSLY, IT HAS BEEN DETERMINED THAT NO ADDITIONAL ACTIONS WILL BE NECESSARY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    FROM PART OF PAD SEPARATED FROM STICKY BACK IF PAD IS TOUCHED DURING A PROCEDURE. PAD COMES APERTURE FROM STICKY BACK, THE X-RAY STAY WITH STICKY BACK AND FOAM IS NOW DANGEROUS TO LOSE WITHOUT ABILITY TO TRACK. THEY DID ACCOUNT FOR FOAM IN BOTH INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291667 DEFOGGER ENDOSCOPE AND/ OR ACCESSORIES KOG DEROYAL INDUSTRIES 36524421

    Patients

    Seq Age Sex Outcome Treatment
    1