BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR S90 ELECTRODE

    MDR report key: 2123017 · Received June 14, 2011

    Report

    Report Number
    1221934-2011-00238
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K041135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT DEVICE WAS RECEIVED FROM THE FACILITY VIA OUR DECONTAMINATOR; HOWEVER, DUE TO THE FACT THAT THE RETURNED DEVICE WAS NOT MARKED WITH THE CORRECT RETURN AUTHORIZATION FROM THE FACILITY, IT WAS NOT POSSIBLE TO ASSOCIATE THE DEVICE TO ANY PARTICULAR FILE. DUE DILIGENCE WAS PERFORMED IN ATTEMPTING TO ASSOCIATE THE RETURN TO A FILE, HOWEVER IT WAS NOT POSSIBLE, AND AFTER SOME TIME, THE DEVICE WAS DISPOSED OF. AT SOME POINT SUBSEQUENT TO THIS THE FACILITY MADE A QUERY ASKING FOR A STATUS UP-DATE ON THE EVALUATION OF THE ELECTRODE, AND, THROUGH THE ENSUING DIALOGUE, THE FACILITY CONTACT PRESENTED A NUMBER THAT THEY USED TO IDENTIFY THE RETURN, WHICH WAS TRACED TO THE DECONTAMINATOR, WHO INTERN PROVIDED THEIR SHIPPING/TRACKING IDENTIFICATION FOR THE BULK PACKAGE THAT THEY SENT TO US WHICH CONTAINED, AMONGST OTHER DEVICES, THE REPORTED COMPLAINT DEVICE, AND THAT POINT WE WERE ABLE TO MAKE AN ASSOCIATION, UNFORTUNATELY THE DEVICE HAD ALREADY BEEN DISCARDED. ALTHOUGH THERE WAS ALREADY A LINE OF COMMUNICATION SET UP VIA E-MAILS AND PHONE CONVERSATIONS BETWEEN THE FACILITY CONTACT AND THE MITEK COMPLAINTS DEPARTMENT, THE CALLER, FOR WHATEVER REASON, CALLED AND REITERATED THE ISSUE THROUGH CUSTOMER SERVICE AND WAS GIVEN YET ANOTHER REFERENCE NUMBER BASED ON CUSTOMER SERVICE'S INTERACTION WITH THEM. THE TRAVELOGUE FOR THIS DEVICE IS CONVOLUTED AND WAS OUTSIDE OF MITEK'S CONTROL; IN ESSENCE, THE COMPLAINT DEVICE HAS BEEN DISPOSED OF AND NO EVALUATION CAN BE HAD. TO FURTHER COMPLICATE MATTERS, THERE IS A CONFLICT OF INFORMATION BETWEEN WHAT THE CALLER/REPORTER REPORTED AS THE SPECIFIC DEVICE ISSUE, AND, WHAT THE USER STAFF NARRATED TO THE MITEK REPRESENTATIVE AS BEING THE PROBLEM: THE CALLER REPORTED THAT A PORTION OF THE DISTAL TIP BROKE OFF INTO THE BODY, AND THE STAFF REPORTS THAT SOME OF THE BLACK INSULATION MATERIAL ON THE ELECTRODE FLAKED OFF INTO THE BODY. 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. FOR THIS PARTICULAR ISSUE, WE CANNOT DISCERN WHAT THE DEVICE'S PROBLEM WAS, OR, WHAT THE ROOT OR UNDERLYING CAUSE MAY HAVE BEEN. AT THIS POINT IN TIME NO FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFORMATION RECEIVED THAT IS RELATIVE, GERMANE, AND CLARIFYING 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.

    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.

    Description of Event or Problem · 1

    THE FACILITY CALLED AND REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, A PORTION OF THE DISTAL TIP OF AN S90 ELECTRODE CAME OFF AND INTO THE PATIENT'S JOINT SPACE, FRAGMENT REMAINS IN THE BODY. HOWEVER, THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK VAPR S90 ELECTRODE ELECTROSURGICAL: CUTTING & COAGULATING GEI DEPUY MITEK NA M1004114

    Patients

    Seq Age Sex Outcome Treatment
    1