BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1230836 · Received November 6, 2008

    Report

    Report Number
    2084725-2008-00729
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 10, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Removal / Correction Number
    Z-0844-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - THIS ISSUE HAS BEEN ADDRESSED WITH A CUSTOMER LETTER RELATED TO CORRECTION & REMOVAL. REF MDR: 2084725-2008-00728.

    Description of Event or Problem · 1

    THE ASP ACCOUNT EXECUTIVE CALLED TO REPORT THAT A CUSTOMER PROCESSED AN ACN 2 SEMI RIGID URETEROSCOPE IN THE STERRAD 100S. THE TECH WHO PROCESSED THIS WAS NOT AWARE THAT THIS SHOULD NOT BE PROCESSED. THE CUSTOMER REPORTED THAT THE STERRAD HAS BEEN IN USE SINCE 2004. HE DETERMINED THAT THE SCOPE HAS BEEN PROCESSED IN THE STERRAD FOR 4 PLUS YRS. THE CUSTOMER REPORTED THAT HIS FACILITY IS GOING BACK TO 2004 TO DETERMINE HOW MANY PTS, THE SCOPE HAS BEEN USED ON. HE FEELS THAT THERE MAY HAVE BEEN 40 PTS THAT THIS SCOPE WAS USED ON. THE CUSTOMER THEN REPORTED THAT THE DEPT OF HEALTH INVESTIGATION CONCLUDED THAT THE FACILITY DID NOT HAVE TO NOTIFY THE PTS, AS THIS WAS CLASSIFIED AS A CLASS B INCIDENT ACCORDING TO CDC GUIDELINES. THE CUSTOMER REPORTED THAT THERE HAS NOT BEEN ANY HEALTH COMPLICATIONS RELATED TO THIS ISSUE. THE CUSTOMER HAS TWO STERRAD 100S THAT THIS PARTICULAR SCOPE MAY HAVE BEEN PROCESSED IN. THE ASP CUSTOMER CARE REVIEWED WITH THE CUSTOMER "WHAT CAN I STERILIZE IN THE STERRAD 100 S STERILIZER" REGARDING LUMEN CLAIMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACN SEMI RIGID UTEROSCOPE:| SN: UNK