BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 3961388 · Received July 28, 2014

    Report

    Report Number
    2150060-2014-10002
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MINNTECH CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K832458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), SERVICE HISTORY, TRENDING OF THE PRODUCT MALFUNCTION CODE, AND SYSTEM RISK ANALYSIS (SRA). THE DHR WAS REVIEWED AND REVEALED THE UNIT MET MANUFACTURERS SPECIFICATIONS AT THE TIME OF RELEASE. THE SERVICE HISTORY FOR THE PAST SIX MONTHS ((B)(6) 2014) DID NOT IDENTIFY ANY SIGNIFICANT TREND. THE TREND FOR THE PRODUCT MALFUNCTION CODE OF PROCEDURE RELATED WAS ASSESSED FROM (B)(6) 2013 THROUGH (B)(6) 2014. THERE WAS NO SIGNIFICANT TREND. THE SRA WAS REVIEWED FOR THE ISSUE OF PROCEDURE RELATED AND THE RISK WAS CONSIDERED TO BE "LOW." AT THIS TIME, THERE IS NO ADDITIONAL INFORMATION REGADING THE PATIENT AND THE RELEASED LOAD. IT WAS REPORTED THE PATIENT IS FINE AND FURTHER FOLLOW-UP WITH THE CUSTOMER REGARDING THE STATUS OF THE PATIENT WAS UNSUCCESSFUL. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, ADVANCED STERILIZATION PRODUCTS (ASP) WILL RE-OPEN THE COMPLAINT FOR FURTHER INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED. NO FURTHER INVESTIGATION IS NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THEIR CYCLES CANCEL WHEN THEY TRY AND RUN A LOAD WITH THEIR AUTOMATIC ENDOSCOPE REPROCESSOR (AER). THE CUSTOMER STATED THEY ¿DID NOT KNOWINGLY RELEASE¿ THE SCOPE FROM THE CANCELLED CYCLE AND USED IT ON A PATIENT. THE PATIENT WAS TESTED AND IS REPORTED TO BE ¿FINE¿. THIS EVENT IS BEING REPORTED TO THE FDA FOR USER ERROR. A SCOPE WAS RELEASED AND USED ON A PATIENT AFTER A CANCELLED CYCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438187 ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER AER EQUIPMENT KOG MINNTECH CORPORATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1