BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARIT ANTI-FOG KIT

    MDR report key: 8367379 · Received February 25, 2019

    Report

    Report Number
    1000221028-2019-00113
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Date of Event
    October 30, 2018
    Report Date
    February 21, 2019
    Manufacturer
    PRESERVATION SOLUTIONS, INC.
    Product Code
    OCT
    UDI-DI
    10810805000146
    PMA / PMN Number
    K022826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISTRIBUTION COMPANY NOTIFIED PRESERVATION SOLUTIONS, INC. (PSI, MANUFACTURER) ON JANUARY 18, 2019 OF A COMPLAINT THAT INCLUDED AN ALLEGATION FROM AN END USER THAT THE CLEARIT ANTI-FOG SOLUTION KIT DEVICE WAS NOT FUNCTIONING AS INTENDED. THE DEVICE IS TO BE USED TO HELP PREVENT THE FOGGING OF ENDOSCOPE LENS DURING PROCEDURES. THE ALLEGATION WAS THAT THE CLEARIT ANTI-FOG SOLUTION DID NOT PREVENT THE LENS FROM FOGGING DURING PROCEDURE. ADDITIONAL FOLLOW-UP INFORMATION FROM THE DISTRIBUTOR REGARDING THE COMPLAINT ON JANUARY 21, 2019 THAT INCLUDED INFORMATION THAT THE ALLEGED INCIDENT TOOK PLACE ON (B)(6) 2018 THAT INCLUDED A STATEMENT REGARDING THE IMPACT OF THE COMPLAINT AS "PATIENT SAFETY ISSUE NOTED". PSI REQUESTED ADDITIONAL INFORMATION REGARDING THIS STATEMENT AND FURTHER INFORMATION WAS PROVIDED FROM THE END USER VIA THE DISTRIBUTOR THAT INDICATED IF THE ANTI-FOG SOLUTION IS INEFFECTIVE, TIME IS WASTED CLEARING THE LENS OF FOG. THIS WOULD RESULT IN REPEATED ENTRY INTO THE TRACHEA AND BRONCHUS WITH THE ENDOSCOPE WHICH COULD POTENTIALLY CAUSE TRAUMA TO THE AIRWAY AND PROLONG A PROCEDURE. AS OF (B)(6) 2019, PSI IS AWAITING THE RETURN OF UNUSED PRODUCT FROM THE END USER/DISTRIBUTOR FOR EVALUATION. PRODUCT LOT RELEASED (B)(6) 2018 WITH A TOTAL QUANTITY OF (B)(4) UNITS. ALL INVENTORY FROM THIS LOT HAS SHIPPED FROM MANUFACTURER'S FACILITY AS OF (B)(4) 2019. NO ADDITIONAL COMPLAINTS RECEIVED BY MANUFACTURER (PSI) REGARDING THIS PRODUCT AND/OR LOT NUMBER AS OF FEBRUARY 21, 2019. NO ADDITIONAL REPORTS OF INEFFECTIVE USE OF THE DEVICE RECEIVED BY THE MANUFACTURER (PSI) REGARDING THIS PRODUCT AND/OR LOT NUMBER AS OF FEBRUARY 21, 2019.

    Description of Event or Problem · 1

    DISTRIBUTION COMPANY NOTIFIED PRESERVATION SOLUTIONS, INC. (PSI, MANUFACTURER) ON JANUARY 18, 2019 OF A COMPLAINT THAT INCLUDED AN ALLEGATION FROM AN END USER THAT THE CLEARIT ANTI-FOG SOLUTION KIT DEVICE WAS NOT FUNCTIONING AS INTENDED. THE DEVICE IS TO BE USED TO HELP PREVENT THE FOGGING OF ENDOSCOPE LENS DURING PROCEDURES. THE ALLEGATION WAS THAT THE CLEARIT ANTI-FOG SOLUTION DID NOT PREVENT THE LENS FROM FOGGING DURING PROCEDURE. ADDITIONAL FOLLOW-UP INFORMATION FROM THE DISTRIBUTOR REGARDING THE COMPLAINT ON JANUARY 21, 2019 THAT INCLUDED INFORMATION THAT THE ALLEGED INCIDENT TOOK PLACE ON (B)(6) 2018 THAT INCLUDED A STATEMENT REGARDING THE IMPACT OF THE COMPLAINT AS "PATIENT SAFETY ISSUE NOTED". PSI REQUESTED ADDITIONAL INFORMATION REGARDING THIS STATEMENT AND FURTHER INFORMATION WAS PROVIDED FROM THE END USER VIA THE DISTRIBUTOR THAT INDICATED IF THE ANTI-FOG SOLUTION IS INEFFECTIVE, TIME IS WASTED CLEARING THE LENS OF FOG. THIS WOULD RESULT IN REPEATED ENTRY INTO THE TRACHEA AND BRONCHUS WITH THE ENDOSCOPE WHICH COULD POTENTIALLY CAUSE TRAUMA TO THE AIRWAY AND PROLONG A PROCEDURE. AS OF (B)(6) 2019, PSI IS AWAITING THE RETURN OF UNUSED PRODUCT FROM THE END USER/DISTRIBUTOR FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161632 CLEARIT ANTI-FOG KIT ANTI FOG SOLUTION OCT PRESERVATION SOLUTIONS, INC. PS119206 10810805000146

    Patients

    Seq Age Sex Outcome Treatment
    1