BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1386159 · Received March 11, 2009

    Report

    Report Number
    2084725-2009-00173
    Event Type
    Malfunction
    Date Received
    March 11, 2009
    Date of Event
    August 22, 2008
    Report Date
    August 22, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: OTHER: ASP ASSESSMENT: THE REPORTED ISSUE HAS BEEN DOCUMENTED INTO ASP'S COMPLAINT SYSTEM FOR TRACKING AND TRENDING PURPOSES. AS MANUFACTURERS INTRODUCE NEW TECHNOLOGIES AND MAKE MATERIALS, MANUFACTURING AND REPAIR PROCESS CHANGES TO THEIR DEVICES, ASP DOES NOT HAVE THE MEANS TO PROVIDE UP-TO-DATE INFO RELATED TO SPECIFIC BRANDS AND MODELS OF MEDICAL DEVICES THAT MAY BE PROCESSED IN THE STERRAD SYSTEMS. ASP MAY WORK WITH SPECIFIC DEVICE MANUFACTURERS TO TEST FOR COMPATIBILITY IN THE STERRAD SYSTEMS, HOWEVER, THE COMPATIBILITY DATA AND THE DECISION AS TO WHETHER THE DEVICE IS COMPATIBLE IN THE STERRAD SYSTEMS RESIDES WITH THE DEVICE MANUFACTURER. A HEALTH HAZARD EVAL (HHE) WAS CONDUCTED FOR DEVICE INCOMPATIBILITY AND THE RESULTING RISK INDEX WAS 6, OR LOW RISK. IN ORDER TO FURTHER MITIGATE THE RISK, IN OCTOBER 2007, A CAPA WAS INITIATED AND CUSTOMER LETTER WAS SENT TO ALL STERRAD SYSTEMS USERS. THE LETTER SUGGESTED CONTACTING THE DEVICE MANUFACTURER REGARDING MATERIAL COMPATIBILITY AND FUNCTIONAL PERFORMANCE QUESTIONS OF THE DEVICE WITH THE STERRAD SYSTEMS. A RISK ASSESSMENT WAS PERFORMED FOR DAMAGE TO CUSTOMER DEVICE AFTER PROCESSING IN THE STERRAD SYSTEMS. THE ASSESSED RISK WAS DETERMINED TO BE AS LOW AS PRACTICAL AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY FOR THIS SERIAL NUMBERED SYSTEM DID NOT REVEAL A SIGNIFICANT TREND OF COMPLAINTS REPORTED FOR THIS PROBLEM CODE. ASP WILL CONTINUE TO TRACK AND TREND. THIS COMPLAINT WAS PART OF A RETROSPECTIVE REVIEW CONDUCTED BY ASP.

    Description of Event or Problem · 1

    PER CUSTOMER, THE FOLLOWING DEVICES WERE DAMAGED AFTER BEING PROCESSED: BIPOLAR, MIZUHO CO, LTD. MADE, PART# 07-780-05 AND #07-780-06, TOTAL 5 PIECES. BIPOLAR CORD, MIZUHO CO. LTD. MADE, PARTS# UNK, TOTAL 3 PIECES. THE DEVICES WERE PREVIOUSLY PROCESSED UNDER EOG STERILIZATION. AFTER STERRAD PROCESSING, THE COATING PEELED OFF THE BIPOLAR; BIPOLAR CORD GOT SOME WHITE SUBSTANCE AND THE RUBBER CRACKED. THERE WERE NO REPORTS OF INJURIES.

    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 NA BIPOLAR DEVICES| BIPOLAR DEVICES