BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1221934-2018-55157

    MDR report key: 8025675 · Received October 31, 2018

    Report

    Report Number
    1221934-2018-55157
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    September 20, 2018
    Report Date
    September 20, 2018
    PMA / PMN Number
    K113545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE COMPLAINT DEVICE WAS RECEIVED AT THE SERVICE AND REPAIR CENTER FOR EVALUATION. PER SERVICE MANUAL, OPERATIONAL AND DIAGNOSTIC ANALYSIS CONFIRMED THE REPORTED ISSUE OF CONNECTION/INITIALIZATION FAILURE. REPLACED ID BOARD AS IDENTIFIED IN THE INVESTIGATION TO ADDRESS THE REPORTED ISSUE. THE MISSING DUST COVER WAS REPLACED. THE SOFTWARE WAS UPGRADED PER TECHNICAL BULLETIN. THE REPAIR AND TESTING OF THE UNIT WAS COMPLETED PER THE SERVICE MANUAL, BRINGING THE UNIT BACK TO FULL FUNCTIONALITY. THE UNIT PASSED ALL FUNCTIONAL TESTS AND IS FULLY OPERATIONAL. THESE DEVICES ARE FREQUENTLY SENT IN FOR REPAIR DUE TO THE NATURE OF THEIR USE, AND LONGEVITY IN THE FIELD. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. CORRECTION: UPON FURTHER REVIEW OF THE COMPLAINT, IT WAS DETERMINED THAT THE REPORTED MALFUNCTION IS UNLIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH IF IT WERE TO RECUR. THEREFORE, THIS COMPLAINT IS NOT REPORTABLE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. (B)(4). THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING PRE-SURGERY, IT WAS OBSERVED THAT THE VAPR VUE GENERATOR DEVICE SETTINGS WERE NOT IN SYNC AND THEN DISPLAYED INTERNAL ERROR. THERE WAS NO PATIENT HARM OR SURGICAL DELAY REPORTED. NO OTHER DEVICE WAS USED FOR THE PROCEDURE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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.

    Patients

    Seq Age Sex Outcome Treatment
    1