BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR P90 ELECTRODE

    MDR report key: 3003932 · Received March 14, 2013

    Report

    Report Number
    1221934-2013-00062
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K082643
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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. AWAITING RETURN.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND SUBJECTED TO A VISUAL EXAMINATION; BOTH WITH THE NAKED EYE AND UNDER MAGNIFICATION. IT IS NOTED THAT FROM THE HANDLE ON, THE SHAFT IS BENT AT ABOUT 35 DEGREES, WHICH IS INDICATIVE OF EXCESSIVE MECHANICAL HANDLING. ALSO, THE BOTTOM HALF OF THE FACE PLATE AT THE DISTAL WORKING TIP IS MISSING, BROKEN AWAY, POSSIBLY THROUGH THE SAME TRAUMA INFLICTED TO THE SHAFT. 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 SIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE ARE ATTRIBUTING THE DEVICE'S CONDITION TO TECHNIQUE, A USER ISSUE. AT THIS POINT IN TIME, NO CORRECTIVE OR FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFORMATION RECEIVED THAT IS RELATIVE AND GERMANE TO THIS ISSUE. ALSO, 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 PROCEDURE, THEY NOTED THAT A PORTION OF THE DISTAL TIP OF A P90 ELECTRODE WAS MISSING. THEY DO NOT KNOW IF THE FRAGMENT BROKE OFF IN THE BODY OR NOT; IMAGING COULD NOT CONFIRM THE PRESENCE OF ANY FOREIGN MATERIAL IN THE BODY. IN ANY EVENT, THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107703 MITEK VAPR P90 ELECTRODE ELECTROSURGICAL DEVICE GEI DEPUY MITEK NA 1212003

    Patients

    Seq Age Sex Outcome Treatment
    1