BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK VAPR COOL PULSE ELECTRODE W/HAND CONTROLS

    MDR report key: 4100191 · Received September 18, 2014

    Report

    Report Number
    1221934-2014-00412
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    July 1, 2014
    Report Date
    August 28, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K100638
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY MITEK; HOWEVER, IT IS NOT KNOWN IF IT WILL BE RECEIVED WITHIN THE 30 DAY REPORTING REQUIREMENT, THEREFORE DEPUY MITEK WOULD LIKE TO FILE THIS INITIAL MEDWATCH REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT. AWAITING RETURN

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS NOT BEEN RETURNED AND NO FURTHER INFORMATION HAS BEEN PROVIDED TILL DATE THAT WOULD HELP IN THE INVESTIGATION. FURTHERMORE, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A BATCH HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. WITHOUT PHYSICALLY EVALUATING THE DEVICE, THE EXACT LOCATION OF TIP BREAK OR A ROOT CAUSE CANNOT BE DISCERNED. 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

    ELECTRODE CERAMIC TIP BREAKAGE IN THE BONE. THE METAL TIP LOCATED AT THE END OF THE ELECTRODE IS DETACHED 2 TIMES DURING THE PROCEDURE. THE TIP WAS LEFT IN IRRIGATED ARTICULATION BY THE ARTHROPUMP. THE SURGEON HAD TO TAKE THE TIME TO REMOVE THE METAL CAPS BEFORE TO FINISH THE INTERVENTION. NO CONSEQUENCES TO THE PATIENT-ANOTHER LIKE DEVICE WAS USED. SEE ASSOCIATED MED WATCH # 1221934-2014-00411 FOR SECOND DEVICE.

    Description of Event or Problem · 1

    ELECTRODE CERAMIC TIP BREAKAGE IN THE BONE. THE METAL TIP LOCATED AT THE END OF THE ELECTRODE IS DETACHED 2 TIMES DURING THE PROCEDURE. THE TIP WAS LEFT IN IRRIGATED ARTICULATION BY THE ARTHROPUMP. THE SURGEON HAD TO TAKE THE TIME TO REMOVE THE METAL CAPS BEFORE TO FINISH THE INTERVENTION. NO CONSEQUENCES TO THE PATIENT-ANOTHER LIKE DEVICE WAS USED. SEE ASSOCIATED MED WATCH # 1221934-2014-00411 FOR SECOND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577610 MITEK VAPR COOL PULSE ELECTRODE W/HAND CONTROLS ELECTROSURGICAL: CUTTING AND COAGULATING GEI DEPUY MITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R