BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBE 8225101 5PK STD PRASS FLUSH TIP

    MDR report key: 3030067 · Received April 2, 2013

    Report

    Report Number
    1045254-2013-00317
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K934426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCT: PROBE 8225101, 5PK STD PRASS FLUSH TIP, LOT# 0206211978, MANUFACTURED OCTOBER 1, 2012, USE BEFORE SEPTEMBER 29, 2020. (B)(4). PRODUCT NOT RETURNED FOR ANALYSIS, NO INFORMATION AVALIABLE. METHOD: ACTUAL DEVICE NOT EVALUATED.

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED (B)(4) 2013. EVALUATION SUMMARY: PRODUCT ANALYSIS CONFIRMED THE COMPLAINT, FROM VISUAL EVALUATION, ONE PROBE ASSEMBLY EXHIBITED THE INNER CANNULA EXPOSED NEAR THE DISTAL END (CLOSED TO THE TIP OF THE DEVICE) SINCE THE COATING ON THE PROBE WAS TORN / DAMAGED LIKELY DUE TO CUSTOMER'S EXCESSIVE USE OF THE DEVICE. THE TORN COATING PIECE WAS NOT RETURNED FOR EVALUATION. THE SECOND PROBE EXHIBITED MINOR CIRCULAR RING AT PROXIMAL END WHICH INDICATES THAT THE PROBE WAS SNUGGED INTO THE HANDLE BY THE CUSTOMER. A SAMPLE HANDLE ASSEMBLY WAS TAKEN AND BOTH PROBES WERE FOUND TO SECURELY ATTACH INSIDE THE HANDLE ASSEMBLY WITHOUT ANY ISSUES. RESISTANCE READINGS WERE TAKEN AND WERE FOUND TO BE LESS THAN 2 OHMS MEETING THE REQUIRED MANUFACTURING SPECIFICATION. ADDITIONALLY, A FUNCTIONAL TEST WAS PERFORMED USING THE NIM NEURO 3.0 INTERFACE, AND NIM 3.0 STIMULATOR WHICH REVEALED THAT THE PROBE FUNCTIONED AS INTENDED / ABLE TO PROVIDE STIMULATION WITHOUT OBSERVING ANY ISSUES / ANOMALIES. METHOD: MICROSCOPIC INSPECTION. RESULTS: STRESS PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROBE WAS USED DURING A DEMO IN THE OR, THE SURGEON WAS NOT FAMILIAR WITH THE PROBE AND PUSHED TOO HARD WHEN STIMULATING. THE PROBE BENT AND WAS BENT BACK SEVERAL TIMES. THE SURGEON MENTIONED THAT PARTS OF THE PROBE WERE CRUMBLED INTO THE OPERATION FIELD. THE PARTS WERE TAKEN OUT OF THE OPERATION FIELD MANUALLY; THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134879 PROBE 8225101 5PK STD PRASS FLUSH TIP STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8225101 0206029248

    Patients

    Seq Age Sex Outcome Treatment
    1 PROBE 8225101 5PK STD PRASS FLUSH TIP