BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAND 900-115 15MM DISPOSABLE

    MDR report key: 6099197 · Received November 14, 2016

    Report

    Report Number
    1226420-2016-00177
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 20, 2016
    Report Date
    February 16, 2017
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K152596
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4) RECEIPT OF COMPLAINT INFORMATION TRIGGERED FORMAL INVESTIGATION (B)(4) WHICH IS CURRENTLY IN PROCESS.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A BREAST ONCOLOGY CASE, ONE OF THE WIRES BROKE DURING CAPTURE ON THE INTACT WAND. PART OF THE WIRE REMAINED IN THE PATIENT. THE SURGEON REPORTED IT WOULD NOT IMPACT THE PATIENT; THEREFORE THE WIRE WAS NOT REMOVED. THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    DURING A BREAST ONCOLOGY CASE, ONE OF THE WIRES BROKE DURING CAPTURE ON THE INTACT WAND. PART OF THE WIRE REMAINED IN THE PATIENT. THE SURGEON REPORTED IT WOULD NOT IMPACT THE PATIENT; THEREFORE THE WIRE WAS NOT REMOVED. THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    DURING A BREAST ONCOLOGY CASE, ONE OF THE WIRES BROKE DURING CAPTURE ON THE INTACT WAND. PART OF THE WIRE REMAINED IN THE PATIENT. THE SURGEON REPORTED IT WOULD NOT IMPACT THE PATIENT; THEREFORE THE WIRE WAS NOT REMOVED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750495 WAND 900-115 15MM DISPOSABLE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC 900-115 E37153

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR