BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASX BLADELESS

    MDR report key: 1894330 · Received November 9, 2010

    Report

    Report Number
    3005075853-2010-06390
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 16, 2010
    Report Date
    October 16, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K062209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SLEEVE. THE ANALYSIS RESULTS FOUND THAT THE DEVICE SHOWED DAMAGE AT THE TIP OF THE SLEEVE. ONE POSSIBLE CAUSE FOR THIS TYPE OF DAMAGE MAY BE INTERACTION WITH AN ENERGIZED DEVICE USED DURING THE PROCEDURE. CAUTION SHOULD BE TAKEN TO AVOID CONTACT BETWEEN AN ENERGIZED DEVICE AND THE TROCAR DURING THE SURGICAL PROCEDURE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL AND VENTRICULAR PACING LEADS WERE CAPPED, DUE TO HIGH THRESHOLDS. NEW ATRIAL AND VENTRICULAR LEADS WERE IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS DISCOVERED THAT THE TIP OF THE SLEEVE IS MELTED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASX BLADELESS LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1