BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENDED TIP APPLICATOR BOX OF 5

    MDR report key: 1130009 · Received August 19, 2008

    Report

    Report Number
    3003157248-2008-00022
    Event Type
    Malfunction
    Date Received
    August 19, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 21, 2008
    Manufacturer
    CONFLUENT
    Product Code
    FMF
    PMA / PMN Number
    K072790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE PROCEDURE WAS THE REMOVAL OF A PITUITARY TUMOR THROUGH AN ENDONASAL APPROACH. AT THE CONCLUSION OF THE PROCEDURE, (B) (6) USED THE EXTENDED TIP APPLICATOR TO APPLY DURASEAL TO OBTAIN WATERTIGHT DURAL CLOSURE. AFTER REMOVING THE APPLICATOR FROM THE SURGICAL FIELD, IT WAS NOTICED THAT THE TIP WAS NO LONGER ATTACHED TO THE APPLICATOR. (B) (6) DISCOVERED THAT THE TIP WAS LODGED IN THE APPLIED DURASEAL. HE RETRIEVED THE TIP FROM THE APPLIED SEALANT. THERE WAS NO ADVERSE EFFECT ON THE PATIENT BECAUSE THE MISSING TIP WAS LOCATED AND RETRIEVED PRIOR TO WOUND CLOSURE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING AN ENDONASAL SURGERY PROCEDURE, THE TIP OF THE EXTENDED TIP APPLICATOR CAME OFF. THE TIP WAS RETRIEVED BY THE SURGEON WITH NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENDED TIP APPLICATOR BOX OF 5 PISTON SYRINGE, FMF FMF CONFLUENT NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1