BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V MUELLER / ELMED L-HOOK CAUTERY TIP

    MDR report key: 18187414 · Received November 21, 2023

    Report

    Report Number
    1412854-2023-07010
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    October 12, 2022
    Report Date
    November 21, 2023
    Manufacturer
    ELMED INCORPORATED
    Product Code
    GEI
    PMA / PMN Number
    K181173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT IS NOT AVAILABLE FOR REVIEW/INVESTIGATION V MUELLER PROVIDED US WITH A COPY OF THE CUSTOMER'S SUBMISSION; NOTING THE SAMPLE, LOT NUMBER AND PICTURES ARE NOT AVAILABLE. THEY ASKED FOR PICTURES OF THIS PARTICULAR ITEM SO THAT THEY COULD WRITE UP A COMPLAINT FROM THEIR END. ELMED INC ASKED V MUELLER TO RECONFIRM THAT THE ACTUAL PRODUCT WAS NOT AVAILABLE AND COULD NOT BE SENT BACK TO US. THEY CONFIRMED STATING THAT THE CUSTOMER DID NOT HAVE IT. LAST TIME OUR DISTRIBUTER (V. MUELLER) ORDERED THIS PARTICULAR ITEM WAS AT LEAST 6 YEARS AGO. NO OTHER COMPLAINTS HAVE BEEN RECEIVED ON THIS PRODUCT AS PER THE CUSTOMER'S REPORT, THERE WAS NO HARM TO THE PATIENT

    Description of Event or Problem · 0

    DURING A LAPAROSCOPIC CHOLECYSTECTONY, THE SURGEON WAS USING THE CAUTERY DEVICE. WHEN HE REMOVED THE "L-HOOK," THE SCRUB NURSE NOTICED THAT THE V-MUELLER L HOOK CAUTERY TIP WAS NO LONGER IN PLACE ON THE SHAFT OF THE DEVICE. AN ABDOMINAL X-RAY WAS TAKEN AFTER THE PROCEDURE SHOWING NO RETAINED FOREIGN OBJECT. THE INSTRUMENT WAS TAKEN OUT OF SERVICE. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722751 V MUELLER / ELMED L-HOOK CAUTERY TIP ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ELMED INCORPORATED F265.00 NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male