BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR S90 4.0MM W/INTEGR HDP -EA

    MDR report key: 7677717 · Received July 11, 2018

    Report

    Report Number
    1221934-2018-51867
    Event Type
    Malfunction
    Date Received
    July 11, 2018
    Date of Event
    April 26, 2016
    Report Date
    April 26, 2016
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    UDI-DI
    10886705009398
    PMA / PMN Number
    K122425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE COMPLAINT DEVICE WAS RECEIVED AND FORWARDED TO THE SUPPLIER FOR EVALUATION. VISUAL OBSERVATION OF THE ELECTRODE REVEALED THE DISTAL TIP SHOWED SIGNS OF ACTIVATION. THERE WAS EVIDENCE OF MELTING AT THE PROXIMAL END OF THE MANIFOLD SURROUNDING THE RETURN BRACE. THE DEVICE PASSED ALL ELECTRICAL TESTING EXCEPT THE HIPOT TESTING DUE TO THE TIP CONDITION. THE DEVICE WAS CONNECTED TO VAPR VUE GENERATOR AND REVEALED NO ISSUES. DUE TO AN INCREASING TREND IN THE NUMBER OF THIS REPORTED FAILURE, A SUPPLIER CAPA HAS INVESTIGATED THIS FAILURE. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO THE DESIGN SUCH THAT THE OPERATOR REQUIRED A SPECIFIC APTITUDE TO ENSURE THE GLUE WICKS SUCCESSFULLY BUT THIS APTITUDE WAS NOT PREVIOUSLY ENSURED BY THE ELECTRODE DESIGN. THE CORRECTIVE ACTION WAS DETERMINED TO BE AWARENESS RETRAINING, CLIP APPLICATION VIDEO RETRAINING HAS BEEN PROVIDED TO THE OPERATORS. THIS CAPA WAS MONITORED FOR ITS EFFECTIVENESS AND THE COMPLAINT RATE WAS BELOW THRESHOLD, THEREFORE INITIAL TRAINING AND AWARENESS TRAINING WAS EFFECTIVE. A BATCH RECORD REVIEW WAS CONDUCTED AND THE RESULTS INDICATED THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE WAS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED SIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WAS RELEASED TO DISTRIBUTION. AT THIS POINT, 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. (B)(4). THIS REPORT IS BEING FILED FROM THE ETQ COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SALES REPRESENTATIVE THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE SHOULDER, IT WAS OBSERVED THAT THE SUCTION ON THE VAPR S90 4.0MM ELECTRODES WITH INTEGRATED HANDPIECE WOULD NOT WORK. A SECOND ONE WAS TIRED BUT DID NOT WORK AT ALL. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH A THIRD DEVICE USING THE SAME GENERATOR WITH NO PATIENT CONSEQUENCES BUT THERE WAS A FIVE MINUTE DELAY IN THE SURGICAL PROCEDURE. THE SALES REP REPORTED THAT THE GENERATOR SETTINGS WERE SET AT DEFAULT AND NEPTUNE WAS USED FOR SUCTION. THE SALES REP REPORTED THAT BOTH ELECTRODES WERE BRAND NEW OUT OF THE BOX. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICES WILL BE RETURNING FOR EVALUATION. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518825 VAPR S90 4.0MM W/INTEGR HDP -EA ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE GEI DEPUY MITEK U1511177 10886705009398

    Patients

    Seq Age Sex Outcome Treatment
    1