BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR

    MDR report key: 3770144 · Received April 24, 2014

    Report

    Report Number
    1221934-2014-00139
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    February 11, 2014
    Report Date
    February 11, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K113545
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS CURRENTLY UNDER INVESTIGATION AT MITEK. A FOLLOW-UP MEDWATCH REPORT WILL BE FILED TO REFLECT THE RESULTS OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    COULD NOT DUPLICATE CUSTOMER'S COMPLAINT OF GENERATOR SMOKING AND OUTPUT SHORTAGE. UNIT WAS EVALUATED, MANY ATTEMPTS OF TESTING, AND DIAGNOSTICS WERE MADE, NO PROBLEM WAS FOUND, UNIT PASSED ALL TESTING. MINOR SCRATCHES ON UNIT FASCIA AND BASE PLATE, NO REPAIRS NEEDED. MULTIPLE SCRATCHES ON UNIT TOP PLATE; REPLACED THE TOP PLATE. PERFORMED SERVICE BULLETIN. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED IN FUTURE, THIS FILE WILL BE RE-OPENED AND A THOROUGH INVESTIGATION WILL BE PERFORMED. DEPUY 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.

    Description of Event or Problem · 1

    THE MATERIALS MANAGER FROM THE FACILITY REPORTED THE GENERATOR, HANDPIECE, AND ELECTRODE WERE ALL SMOKING AND THE CABLES WERE BURNT DURING A SHOULDER PROCEDURE. SHE STATED THE SURGEON SMELT A BURNING SMELL, WAS LOSING POWER FROM THE ELECTRODE AND IT WAS SHORTING OUT ALL AT THE SAME TIME. THE HANDPIECE AND ELECTRODE WERE BECOMING HOT TO TOUCH. ONCE THE SHORTAGE HAPPENED, THEY RECEIVED AN ERROR MESSAGE ON THE GENERATOR THEN THE SCRUB TECHS WERE TURNING THE GENERATOR ON AND OFF AS WELL AS UNPLUGGING AND PLUGGING BACK IN CABLES. IN THE PROCESS OF THIS, THEY NOTICED THE PLUGS ON THE HANDPIECE AND ELECTRODE HAD BLACK MARKS AND THEY WERE SMOKING ALONG WITH THE GENERATOR. AT THIS POINT THEY USED ANOTHER GENERATOR, HANDPIECE AND ELECTRODE TO COMPLETE THE PROCEDURE. SHE ALSO STATED THE ELECTRODE USED ( PRODUCT CODE 225360) WAS REPROCESSED BY (B)(4) AND SHE WAS GOING TO BE REPORTING THAT TO THEM. WHEN THEY WENT TO COMPLETE THE PROCEDURE THEY DID NOT USE A MEDISIS REPROCESSED ELECTRODE. THE GENERATOR IS BEING SENT BACK FOR EVALUATION TO OUR BIOMED DEPARTMENT AND THE HANDPIECE IS COMING BACK HERE FOR EVALUATION. THERE WAS NO PATIENT CONSEQUENCES TO THE PATIENT OR TO PERSONNEL. THERE WAS A 5 MINUTE DELAY. THE MATERIALS MANAGER DID NOT KNOW HOW MANY TIMES THE HANDPIECE WAS USED. NO FURTHER INFORMATION WAS AVAILABLE. ASSOCIATED MEDWATCH 1221934-2014-00140 .

    Description of Event or Problem · 1

    THE MATERIALS MANAGER FROM THE FACILITY REPORTED THE GENERATOR, HANDPIECE, AND ELECTRODE WERE ALL SMOKING AND THE CABLES WERE BURNT DURING A SHOULDER PROCEDURE. SHE STATED THE SURGEON SMELT A BURNING SMELL, WAS LOSING POWER FROM THE ELECTRODE AND IT WAS SHORTING OUT ALL AT THE SAME TIME. THE HANDPIECE AND ELECTRODE WERE BECOMING HOT TO TOUCH. ONCE THE SHORTAGE HAPPENED, THEY RECEIVED AN ERROR MESSAGE ON THE GENERATOR THEN THE SCRUB TECHS WERE TURNING THE GENERATOR ON AND OFF AS WELL AS UNPLUGGING AND PLUGGING BACK IN CABLES. IN THE PROCESS OF THIS, THEY NOTICED THE PLUGS ON THE HANDPIECE AND ELECTRODE HAD BLACK MARKS AND THEY WERE SMOKING ALONG WITH THE GENERATOR. AT THIS POINT THEY USED ANOTHER GENERATOR, HANDPIECE AND ELECTRODE TO COMPLETE THE PROCEDURE. SHE ALSO STATED THE ELECTRODE USED ( PRODUCT CODE 225360) WAS REPROCESSED BY (B)(4) AND SHE WAS GOING TO BE REPORTING THAT TO THEM. WHEN THEY WENT TO COMPLETE THE PROCEDURE THEY DID NOT USE A (B)(4) REPROCESSED ELECTRODE. THE GENERATOR IS BEING SENT BACK FOR EVALUATION TO OUR BIOMED DEPARTMENT AND THE HANDPIECE IS COMING BACK HERE FOR EVALUATION. THERE WAS NO PATIENT CONSEQUENCES TO THE PATIENT OR TO PERSONNEL. THERE WAS A 5 MINUTE DELAY. THE MATERIALS MANAGER DID NOT KNOW HOW MANY TIMES THE HANDPIECE WAS USED. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249406 MITEK VAPR VAPR GENERATORS GEI DEPUY MITEK NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1