BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEAM STER LOCKS ORANGE

    MDR report key: 12751448 · Received November 4, 2021

    Report

    Report Number
    2916714-2021-00208
    Event Type
    Malfunction
    Date Received
    November 4, 2021
    Date of Event
    October 12, 2021
    Report Date
    January 25, 2023
    Manufacturer
    AESCULAP INC.
    Product Code
    JOJ
    UDI-DI
    05055049091927
    PMA / PMN Number
    K890759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER EVALUATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. THEREFORE, THE INVESTIGATION WAS NOT ABLE TO CONFIRM A DEVICE ISSUE THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE DEVICE HISTORY RECORDS (DHR) WERE NOT ABLE TO BE REVIEWED AS NO LOT NUMBER WAS MADE AVAILABLE. HOWEVER, ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO DOCUMENTED PROCEDURES AND A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION OR INVESTIGATION RESULTS WILL BE PROVIDED, IF AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AN ORANGE INDICATOR DOT. THE TAMPER-EVIDENT LOCK WITH INDICATOR DOT DID NOT CHANGE COLOR AFTER PROCESSING. THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1650170 STEAM STER LOCKS ORANGE INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS JOJ AESCULAP INC. US906 05055049091927
    1650171 STEAM STER LOCKS ORANGE INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS JOJ AESCULAP INC. US906 05055049091927

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown