BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 3932521 · Received June 13, 2014

    Report

    Report Number
    2518897-2014-00007
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    April 23, 2014
    Report Date
    June 12, 2014
    Manufacturer
    NOVA CORPORATION
    Product Code
    EOQ
    PMA / PMN Number
    K131028
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN SENT TO PENTAX (B)(4) FOR INVESTIGATION. FIRST RESULTS REVEAL THIS IS A USER ERROR AS THE VALLEYLAB FORCE FX IS NOT APPROVED FOR USE IN BRONCHOSCOPY. FURTHER MORE, THE IFU OF KARL STORZ CLAIMS HF POWER MUST NOT BE USED IN VICINITY OF METAL PARTS OF INSIDE OF AN ENDOSCOPE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A PENTAX FLEXIBLE BRONCHOSCOPE HAD BEEN IN USE FOR A WHILE WHEN THE END BURST INTO FLAMES. THE VALLEYLAB FORCE FX 8 DIATHERMY (S/N (B)(4)) HAD BEEN SET TO 10 WATTS, DELIVERING THE ENERGY DOWN A KARL STORZ CABLE 11770T LOT YZ. IT HAD BEEN NOTED THAT OCCASIONALLY, THERE WAS NO EVIDENCE OF RF POWER LEAVING THE PROBE TIP. THE PATIENT WAS UNDER JET VENTILATION HIGH CONCENTRATION OXYGEN WHILE ATTEMPTS WERE MADE TO USE DIATHERMY TO CAUTERIZE A METAL STENT. INTERNAL BURN MARKS WERE NOTED TO THE PATIENT'S LUNGS. AS A PRECAUTIONARY STEP, THE PATIENT WAS ADMITTED TO HDU FOR OBSERVATION. THE PATIENT WAS ELECTIVELY ANESTHETIZED AGAIN THE FOLLOWING DAY, BUT WAS DISCHARGED ON (B)(6) 2014 IN GOOD CONDITION. THIS HAS BEEN REPORTED BY THE USER TO (B)(6). PENTAX MEDICAL USA WAS MADE AWARE OF THE EVENT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349107 PENTAX UPPER GI VIDEO BRONCHOSCOPE EOQ NOVA CORPORATION EB-1570K NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O KARL STORZ CABLE: 11770T LOT YZ| VALLEYLAB FORCE FX 8 DIATHERMY: SN (B)(4)