BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C3001, SCOPE WARMER BOTTLE

    MDR report key: 15974166 · Received December 13, 2022

    Report

    Report Number
    2027111-2022-00857
    Event Type
    Malfunction
    Date Received
    December 13, 2022
    Report Date
    December 13, 2022
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915116798
    PMA / PMN Number
    K931895
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION CONFIRMED THE COMPLAINANT¿S EXPERIENCE OF A DAMAGED SCOPE WARMER BOTTLE. THE WELD LINE AT THE TOP LIP OF THE BOTTLE WAS BROKEN AND MULTIPLE DENTS WERE OBSERVED ON THE BOTTLE. BASED ON THE CONDITION OF THE RETURNED UNIT, IT IS LIKELY THAT REPORTED EVENT WAS CAUSED BY IMPROPER HANDLING OF THE UNIT AFTER IT WAS SHIPPED FROM APPLIED MEDICAL. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL. BASED UPON THE INITIAL DESCRIPTION OF THE EVENT, THE EVENT WAS NOT REPORTABLE AS IT IS UNLIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. HOWEVER, BASED ON THE EVALUATION OF THE RETURNED UNIT, APPLIED MEDICAL DETERMINED THAT THIS EVENT IS REPORTABLE AS THE BROKEN WELD COULD COMPROMISE THE STERILITY OF THE DEVICE. THIS REPORT IS A COMBINED INITIAL AND FOLLOW-UP REPORT.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: TRANSLATION (VIA DEEPL): DEFECT, NO FUNCTION. ORIGINAL: DEFEKT, KEINE FUNKTION. TODAY WE RECEIVED A CALL AND LATER AN EMAIL FROM [NAME] REGARDING A DEFECT C3001 (LOT: 1320566) AND C3002 (LOT: 1238952) FROM 1010019 [NAME]. [NAME] WAS ASKED TO REPAIR THESE 2 PRODUCTS BUT THEY ARE FINE TO RECEIVE REPLACEMENTS INSTEAD. INTERVENTION: BEFORE USE: NA. PATIENT STATUS: BEFORE USE: NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1980942 C3001, SCOPE WARMER BOTTLE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES C3001 1320566 00607915116798

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown