BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRIGATION TUBING AND CLIPS, HI-FLOW

    MDR report key: 3994349 · Received August 8, 2014

    Report

    Report Number
    1045834-2014-12599
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 19, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PK063688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE HAS NOT BEEN RETURNED AS THIS IS A SINGLE-USE DEVICE; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION; HOWEVER, A REPRESENTATION OF THE CONDITION WAS PROVIDED THROUGH VIDEO. RELIABILITY ENGINEERING EVALUATED THE VIDEO. A VISUAL ASSESSMENT REVEALED THAT THE TUBING WAS NOT PRIMED PROPERLY, CAUSING A BUILD-UP OF PRESSURE IN THE LINE. WHEN THE FOOT PEDAL WAS NOT DEPRESSED, THE FLUID IN FRONT OF THE AIR BUBBLE RELEASED. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE MISUSE/ USER ERROR. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING AN INSERTION OF COCHLEAR IMPLANT SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE IRRIGATION TUBING HAD A CONTINUED FLOWING OF IRRIGATION FLUID. IT WAS FURTHER CLARIFIED THAT WHEN THE USER STOPPED DRILLING, IT WAS OBSERVED THAT THAT IRRIGATION CONTINUED TO FLOW. ACCORDING TO THE REPORTER, THERE SEEMED TO HAVE BEEN AN ¿ISSUE WITH THE IRRIGATION TUBING AFTER FLOW¿ ONCE THE USER STEPPED OFF THE FOOT PEDAL CLAMPING OFF TUBING. THE REPORTER INDICATED THE USER CLAMPED OFF THE TUBING IN THE MIDDLE OF THE THICK PORTION OF THE TUBING. THERE WERE NO DELAYS TO THE SCHEDULED SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467489 IRRIGATION TUBING AND CLIPS, HI-FLOW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT - TU HWE DEPUY SYNTHES POWER TOOLS H203095074

    Patients

    Seq Age Sex Outcome Treatment
    1 FOOT PEDAL DEVICE