BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER PROBE ABLATION DEVICE (DOCTOR'S TERMINOLOGY)

    MDR report key: 1398169 · Received June 1, 2009

    Report

    Report Number
    MW5011267
    Event Type
    Injury
    Date Received
    June 1, 2009
    Date of Event
    January 9, 2008
    Report Date
    May 18, 2009
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I ARRANGED WITH A DOCTOR TO HAVE A COLONOSCOPY, FOR ONLY ONE PURPOSE; TO SCREEN FOR THINGS LIKE POLYPS THAT MIGHT WARN OF IMPENDING CANCER. I HAD NO PROBLEM WITH RECTAL BLEED, OR CHANGE IN BOWEL HABITS. WHEN I RECOVERED FROM ANESTHESIA, THE DOCTOR PRESENTED ME WITH AN ENDOSCOPY REPORT STATING THAT INDICATIONS FOR EXAMINATION INCLUDED OCCASIONAL RECTAL BLEED, AND CHANGE IN BOWEL HABITS. BOTH OF THESE INDICATIONS WERE FALSE. I DID NOT HAVE THESE PROBLEMS, AND HE HAD NO PERMISSION FROM ME TO TAKE ANY ACTION. HOWEVER, IN THE "FINDINGS" SECTION OF HIS REPORT, HE MADE THE FOLLOWING STATEMENT: "PROMINENT 2+ HEMORRHOIDS, LIKELY SOURCE OF RECTAL BLEEDING TREATED WITH HEATER PROBE". THE DOCTOR'S CLAIM TO MEDICARE WAS FOR THE FOLLOWING SERVICE: "1 COLONOSCOPY/CONTROL BLEEDING (45382-5951)". THE REFERENCE TO "CONTROL BLEEDING" IS FALSE. I HAD NO PROBLEM WITH BLEEDING. TWO ADVERSE EVENTS RESULTED FROM THIS PROCEDURE: I SUFFERED FROM AN INFECTION, WITH FEVER (101.6 DEGREES F.). HOSPITALIZATION INVOLVED TWO OUT PATIENT EMERGENCY ROOM TREATMENTS. CHRONIC DIARRHEA. I HAVE CONSULTED WITH SEVERAL DOCTORS ABOUT THIS PROBLEM, BUT NONE HAVE SUGGESTED A SOLUTION. BUT ONE, A COLORECTAL SURGEON, STATED THAT IF A PATIENT DID HAVE ANY BLEEDING, THIS PROCEDURE USING A HEATER PROBE WOULD BE COMPLETELY INEFFECTIVE FOR BLEEDING CONTROL. THIS ADVICE, IN ADDITION TO MY UGLY ADVERSE EFFECTS, HAS LED ME TO SUGGEST THAT THIS PROCEDURE BE CLASSIFIED AS A "PRODUCT USE ERROR". DATES OF USE: 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEATER PROBE ABLATION DEVICE (DOCTOR'S TERMINOLOGY) GEI

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| S