BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 4214469 · Received October 30, 2014

    Report

    Report Number
    9680837-2014-00090
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    MEDTRONIC XOMED INSTRUMENTATION S.A.S
    Product Code
    JYO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON NOVEMBER 26, 2014, ADDITIONAL INFORMATION WAS RECEIVED: "PROCEDURE- ENDOSCOPIC SINUS SURGERY. THE BROKEN PIECE FELL INTO THE ORALPHARYNX. WE HAD TO DO A LARYNGOSCOPY TO REMOVE THE PIECE THROUGH THE MOUTH." LOT # 11-06. DEVICE RETURNED TO MFR: 12/10/2014. THE INSTRUMENT WAS RETURNED FOR EVALUATION. PRODUCT ANALYSIS FOUND "THE TUBE IS BROKEN RIGHT AFTER THE WELD WITH THE HANDLE. IT IS ALSO STRONGLY BENT. NO MATERIAL OR WELDING OR MANUFACTURING DEFECT WAS FOUND. CONSIDERING THE DISTORTION OF THE TUBE AND THE AGE OF THE INSTRUMENT (8 YEARS), THE MOST PROBABLE CAUSE OF THIS RUPTURE IS THE SUCCESSIVE IMPORTANT EFFORTS [STRESS] DURING THE LIFE OF THE INSTRUMENT." DEVICE MANUFACTURE DATE: 11/2006. METHOD: ACTUAL DEVICE EVALUATED; VISUAL INSPECTION ; LABELING EVALUATION. RESULTS :STRESS PROBLEM; FATIGUE PROBLEM. CONCLUSION: USE ERROR CAUSED OR CONTRIBUTED TO EVENT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(6).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ON NOVEMBER 26, 2014, ADDITIONAL INFORMATION WAS RECEIVED: "PROCEDURE- ENDOSCOPIC SINUS SURGERY. THE BROKEN PIECE FELL INTO THE ORALPHARYNX. WE HAD TO DO A LARYNGOSCOPY TO REMOVE THE PIECE THROUGH THE MOUTH."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE PRODUCT BROKE OFF INTO THE PATIENT DURING THE PROCEDURE. THE INSTRUMENT BROKE INTO TWO PIECES. THEY WERE ABLE TO RETRIEVE BOTH PIECES THAT FELL INTO THE PATIENT. THIS CAUSED A DELAY OF SURGERY OF 20 MINUTES. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696924 MICROFRANCE® INSTRUMENT KNIFE, EAR JYO MEDTRONIC XOMED INSTRUMENTATION S.A.S MCO5E 11-06

    Patients

    Seq Age Sex Outcome Treatment
    1 00013 YR