BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR PIEZOELECTRIC SYSTEM

    MDR report key: 4175466 · Received October 15, 2014

    Report

    Report Number
    3000270450-2014-10109
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    September 23, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    JDX
    PMA / PMN Number
    PK100410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE IS CURRENTLY UNAVAILABLE. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; 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

    ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE CONTROL UNIT (MAINBOARD) HAD AN ELECTRICAL FAULT. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. 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 SURGERY, IT WAS DISCOVERED THAT THE HANDPIECE DEVICE WAS DEFECTIVE. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. 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
    653538 HAND PIECE FOR PIEZOELECTRIC SYSTEM SONIC SURGICAL INSTRUMENT AND ACCESSORY/ATTACHMENT JDX SYNTHES SELZACH 601235

    Patients

    Seq Age Sex Outcome Treatment
    1