BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR

    MDR report key: 2122858 · Received June 14, 2011

    Report

    Report Number
    1221934-2011-00237
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 13, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K082643
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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

    NOTHING IS BEING RETURNED FOR EVALUATION; THE COMPLAINT DEVICE HAS BEEN DISCARDED AT THE USER FACILITY. 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 (B)(4) OTHER SIMILAR COMPLAINT FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION; IT IS FROM THE SAME SURGEON AND FACILITY. ALTHOUGH THE DEVICE WAS NOT MADE AVAILABLE FOR EVALUATION, THE FAILURE MODE REPORTED FOR THIS ISSUE HAS HISTORICALLY BEEN ATTRIBUTED TO THE USER ABRADING THE DEVICE AGAINST SOMETHING HARD OR SHARP, LIKE A CANNULA OR SCOPE EDGE. THIS WOULD BE A TECHNIQUE ISSUE. ALTHOUGH THIS IS A HYPOTHESIS AND IS NOT CONCLUSIVE, WE COULD NOT IDENTIFY ANY OTHER FACTORS THAT WOULD RESULT IN SUCH A FAILURE. ALSO, THIS IS A SINGLE USE DEVICE AND IT IS NOT ESTABLISHED IF THE DEVICE IN FACT SAW ONLY ONE USAGE, IN OTHER WORDS THERE IS THE QUESTION OF THE POSSIBILITY THAT THE COMPLAINT DEVICE HAS BEEN REPROCESSED, WHICH WOULD ADD ANOTHER DIMENSION TO THE FAILURE ISSUE. WHEN AND IF THE COMPLAINT DEVICE IS RECEIVED HERE AT DEPUY MITEK IT WILL BE SUBJECTED TO A FAILURE ROOT CAUSE ANALYSIS. IF THE ANALYSIS IDENTIFIES ANY DEFINITIVE ROOT CAUSE OTHER THAN THE ABOVE HYPOTHESIS, A FOLLOW-UP REPORT WILL BE FILED. NO FURTHER ACTION IS WARRANTED, HOWEVER, 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

    OUR REP. IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, A PORTION OF THE INSULATION MATERIAL AT DISTAL END OF AN S90 ELECTRODE CAME OFF AND INTO THE PATIENT'S JOINT SPACE; THEY DO NOT KNOW IF ALL WAS REMOVED. HOWEVER, THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. THE COMPLAINT DEVICE WAS DISCARDED AT THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK VAPR ELECTROSURGICAL: CUTTING & COAGULATING GEI DEPUY MITEK NA 1103126

    Patients

    Seq Age Sex Outcome Treatment
    1