BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR S90 4.0MM W/INTEGR HDP -EA

    MDR report key: 12665114 · Received October 20, 2021

    Report

    Report Number
    1221934-2021-03063
    Event Type
    Malfunction
    Date Received
    October 20, 2021
    Date of Event
    August 27, 2021
    Report Date
    October 19, 2021
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    UDI-DI
    10886705009398
    PMA / PMN Number
    K120095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). INVESTIGATION SUMMARY > ACCORDING TO THE INFORMATION RECEIVED, IT WAS REPORTED THAT DURING THE ROTATOR CUFF REPAIR OPERATION, AFTER CONNECTING WITH GENERATOR, DOES NOT FUNCTION AT ALL, THE SCREEN DID NOT SHOW ANY ALERT CODE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE VAPR S90 4.0MM W/INTEGR HDP -EA WAS RETURNED TO MITEK FOR EVALUATION. MITEK THEN CONDUCTED VISUAL INSPECTION OF DEVICE RECEIVED AND THE PHOTO PROVIDED BY CUSTOMER. VISUAL OBSERVATION UNDER MAGNIFICATION REVEALED TISSUE DEBRIS ON THE ACTIVE TIP. THE ELECTRODE WAS NOT RECEIVED IN ITS ORIGINAL PACKAGING. THERE WAS SALINE RESIDUE IN THE SUCTION TUBE INDICATING THE DEVICE HAD BEEN USED. THE CORD DAMAGE WAS CUT; THEREFORE, IT WAS NOT POSSIBLE TO TEST ITS FUNCTIONALITY. THE PHOTO SHOWED THE DAMAGE IN THE CABLE FOUND DURING THE PHYSICAL ANALYSIS. THIS COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER:U2003098, AND NO NONCONFORMANCES WERE IDENTIFIED. BASED ON VISUAL RESULTS, WE WERE UNABLE TO CONFIRM THE CUSTOMER REPORTED ISSUE. ALSO, WE CANNOT DETERMINE WHAT CAUSED THE USER TO EXPERIENCE REPORTED PROBLEM. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, IN DEPUY SYNTHES MITEK, ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE VAPR S90 4.0MM W/INTEGR HDP DEVICE DID NOT FUNCTION AT ALL THAT NO ALERT CODE WAS PROMPTED ON THE SCREEN ON THE GENERATOR AFTER THE DEVICE WAS CONNECTED TO IT. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT VISUAL OBSERVATION UNDER MAGNIFICATION REVEALED TISSUE DEBRIS ON THE ACTIVE TIP ON THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563105 VAPR S90 4.0MM W/INTEGR HDP -EA ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE GEI DEPUY MITEK LLC US 225370 U2003098 10886705009398

    Patients

    Seq Age Sex Outcome Treatment
    1