BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR PREMIERE 90 DEGREE SUCTION ELECTRODE

    MDR report key: 2922960 · Received January 18, 2013

    Report

    Report Number
    1221934-2013-00021
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K082643
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND VISUALLY EXAMINED: IT IS NOTED THAT THE DEVICE'S DISTAL FACE PLATE IS MISSING; IN GENERAL, THE DEVICE HAS EVIDENCE OF HAVING BEEN IN A BODY. OUTSIDE OF THIS VISUAL OBSERVATION NO FURTHER TESTING HAS BEEN PERFORMED AT MITEK. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT; OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. HISTORICALLY, VIA CAPA INVESTIGATION, POSSIBILITIES FOR THIS FAILURE MODE ARE: OVERLOADING AND STRESSING OF THE DISTAL TIP DURING USE, INCORRECT TOLERANCE, WRONG MATERIAL SPECIFICATION, MISUSE. HOWEVER, TO DATE, THE ONGOING ANALYSIS OF THIS FAILURE MODE HAS NOT BEEN ABLE TO DETERMINE A SPECIFIC ROOT CAUSE, AND HAS ALSO NOT BEEN ABLE TO IDENTIFY ANY GENERIC ROOT CAUSE TO EXPLAIN THE FAILURE AS A WHOLE. ONGOING PRODUCT PROBLEM INVESTIGATIONS AND CORRECTIVE ACTION ACTIVITY HAVE NOT YIELDED ANY FAILURE REASONS THAT ARE OUTSIDE OF THE STATED HYPOTHESES. THE FAILURE MODE AND FREQUENCY RATE FOR THIS DEVICE ARE WELL WITHIN THE FMEA RISK ANALYSIS. THIS COMPLAINT DEVICE HAS BEEN FORWARDED TO THE MANUFACTURE FOR AN IN DEPTH EVALUATION; OUTSIDE OF CONTINUED ANALYSIS ACTIVITY AND TRENDING, NO FURTHER ACTION IS WARRANTED AT THIS TIME; HOWEVER, IF AND WHEN A DEFINITIVE ROOT CAUSE CAN BE DETERMINED, IT WILL BE NOTED IN ANY FUTURE RELATIVE EVALUATION SUMMARIES.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING THAT A PORTION OF THE DISTAL TIP OF A VAPR P90 ELECTRODE BROKE OFF IN THE PATIENT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE. THE PROCEDURE WAS EXTENDED ABOUT SIXTY MINUTES WHILE THE PIECE WAS LOCATED AND RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS THEN COMPLETED WITH NO REPORTED HARM OR CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27192 MITEK VAPR PREMIERE 90 DEGREE SUCTION ELECTRODE ELECTROSURGICAL: CUTTING AND COAGULATING GEI DEPUY MITEK NA 1210035

    Patients

    Seq Age Sex Outcome Treatment
    1