BEUDAMED
    FDA Adverse Event Death Summary report: N

    DORNIER MEDILAS H20 LASER

    MDR report key: 6789781 · Received August 11, 2017

    Report

    Report Number
    1037955-2017-00029
    Event Type
    Death
    Date Received
    August 11, 2017
    Date of Event
    June 29, 2017
    Report Date
    July 13, 2017
    Manufacturer
    DORNIER MEDTECH LASER GMBH
    Product Code
    GEX
    PMA / PMN Number
    K061455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ERROR 14 CODE ON AN H20 REFERS TO DEFECT RELATED TO THE LASER POWER SUPPLY DEPENDING ON THE ERROR SUBCODE (I.E. CODES 1-4) DISPLAYED. ADDITIONAL INFORMATION RELATED TO THE EXACT ERROR CODE DISPLAYED IS UNKNOWN. THE CUSTOMER REPORTED THAT THE DEVICE HAD RECENTLY BEEN REPAIRED TWO WEEKS PRIOR TO THE INCIDENT AFTER DISPLAYING THE SAME ERROR CODE 14. THIS REPAIR WAS NOT PERFORMED BY A DORNIER TECHNICIAN. THERE IS NO INFORMATION ON WHO MADE THE REPAIR OR THEIR QUALIFICATIONS. THIS INCIDENT WAS THE FIRST TIME THE LASER HAD BEEN USED SINCE ITS RECENT REPAIR. THE CAUSE OF THE LOSS OF POWER OF THE LASER AFTER 10 MINUTES OF USE IN NOT KNOWN. NO CONCLUSIONS CAN BE MADE SINCE LIMITED INFORMATION WAS PROVIDED BY THE CUSTOMER IN REFERENCE TO THE COMPLAINT EVENT. ACCORDING TO THE CUSTOMER, THE PATIENT WAS HIGH RISK FOR THE KIDNEY TUMOR ABLATION PROCEDURE AND SUFFERED A HEART-ATTACK AFTER THE PROCEDURE WAS ABANDONED DUE TO THE LOSS OF POWER TO THE LASER. THE PATIENT REMAINED IN "POOR CONDITION" AS OF (B)(6) 2017. NO ADDITIONAL PATIENT INFORMATION AVAILABLE. THIS EVENT OCCURED IN THE UK. DORNIER MEDTECH AMERICA, INC. (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF DORNIER MEDTECH LASER GMBH (THE MANUFACTURER PER EXEMPTION NUMBER E2012001.

    Additional Manufacturer Narrative · 0

    THE ERROR 14 CODE ON AN H20 REFERS TO DEFECT RELATED TO THE LASER POWER SUPPLY DEPENDING ON THE ERROR SUBCODE (I.E. CODES 1-4) DISPLAYED. ADDITIONAL INFORMATION RELATED TO THE EXACT ERROR CODE DISPLAYED IS UNKNOWN. THE CUSTOMER REPORTED THAT THE DEVICE HAD RECENTLY BEEN REPAIRED TWO WEEKS PRIOR TO THE INCIDENT AFTER DISPLAYING THE SAME ERROR CODE 14. THIS REPAIR WAS NOT PERFORMED BY A DORNIER TECHNICIAN. THERE IS NO INFORMATION ON WHO MADE THE REPAIR OR THEIR QUALIFICATIONS. THIS INCIDENT WAS THE FIRST TIME THE LASER HAD BEEN USED SINCE ITS RECENT REPAIR. THE CAUSE OF THE LOSS OF POWER OF THE LASER AFTER 10 MINUTES OF USE IN NOT KNOWN. NO CONCLUSIONS CAN BE MADE SINCE LIMITED INFORMATION WAS PROVIDED BY THE CUSTOMER IN REFERENCE TO THE COMPLAINT EVENT. ACCORDING TO THE CUSTOMER, THE PATIENT WAS HIGH RISK FOR THE KIDNEY TUMOR ABLATION PROCEDURE AND SUFFERED A HEART-ATTACK AFTER THE PROCEDURE WAS ABANDONED DUE TO THE LOSS OF POWER TO THE LASER. THE PATIENT REMAINED IN "POOR CONDITION" AS OF (B)(6) 2017. NO ADDITIONAL PATIENT INFORMATION AVAILABLE. THIS EVENT OCCURED IN THE UK. DORNIER MEDTECH AMERICA, INC. (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF DORNIER MEDTECH LASER GMBH (THE MANUFACTURER PER EXEMPTION NUMBER E2012001. DORNIER MEDTECH AMERICA WAS NOTIFIED ON 08/25/2017 THAT THE PATIENT HAD DIED ON THE (B)(6) 2017 (3 DAYS AFTER DMTA SUBMITTED THE INITIAL MEDWACH REPORT). THE INITIAL INVESTIGATION CONDUCTED BY DMTA IN REFERENCE TO THE COMPLAINT EVENT HAS NOT CHANGED. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER IN REFERENCE TO THE COMPLAINT EVENT.

    Description of Event or Problem · 0

    AN ABLATION OF A KIDNEY TUMOR WAS PERFORMED ON THE PATIENT ON (B)(6) 2017. "LASERING STARTED AT 11:55 THE LASER (DORNIER DUR-HL20 IT ISN'T LISTED ON THE LIST AT THE TOP) WORKED ON SETTINGS 10 AND 1.2 THEN INCREASED TO 10 AND 1.2 THEN AFTER 10 MINUTES TO 10 AND 1.4 THEN IT CAME UP WITH ERROR CODE 14 WHICH WAS THE SAME AS WHAT THE LAST FAULT WAS A COUPLE OF WEEKS AGO WHICH WAS RESOLVED AND PARTS REPLACED AND IT HAD BEEN FINE. THEY DROPPED DOWN TO 0.8 AND 8.0 BUT NO POWER. THEY CHANGED THE FIBRE STILL NO CHANGE. THEY HAD TO ABANDON THE CASE. THE PATIENT IS HIGH RISK BUT HAD TO TRY AS TO STOP THE BLEEDING. HE ISN'T FIT ENOUGH TO GO BACK FOR SURGERY AGAIN TO COMPLETE THE PROCEDURE."

    Description of Event or Problem · 0

    AN ABLATION OF A KIDNEY TUMOR WAS PERFORMED ON THE PATIENT ON (B)(6) 2017. "LASERING STARTED AT 11:55 THE LASER (DORNIER DUR-HL20 IT ISN'T LISTED ON THE LIST AT THE TOP) WORKED ON SETTINGS 10 AND 1.2 THEN INCREASED TO 10 AND 1.2 THEN AFTER 10 MINUTES TO 10 AND 1.4 THEN IT CAME UP WITH ERROR CODE 14 WHICH WAS THE SAME AS WHAT THE LAST FAULT WAS A COUPLE OF WEEKS AGO WHICH WAS RESOLVED AND PARTS REPLACED AND IT HAD BEEN FINE. THEY DROPPED DOWN TO 0.8 AND 8.0 BUT NO POWER. THEY CHANGED THE FIBRE STILL NO CHANGE. THEY HAD TO ABANDON THE CASE. THE PATIENT IS HIGH RISK BUT HAD TO TRY AS TO STOP THE BLEEDING. HE ISN'T FIT ENOUGH TO GO BACK FOR SURGERY AGAIN TO COMPLETE THE PROCEDURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570766 DORNIER MEDILAS H20 LASER HOLMIUM LASER GEX DORNIER MEDTECH LASER GMBH DORNIER MEDILAS H20 LASER

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| O