BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHEATH, RESECTOSCOPE, PROFILE (DEVICE #3)

    MDR report key: 2872579 · Received August 23, 2012

    Report

    Report Number
    1418479-2012-00008
    Event Type
    Injury
    Date Received
    August 23, 2012
    Date of Event
    August 16, 2012
    Report Date
    August 16, 2012
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    FJL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RICHARD WOLF INSTRUMENT (DEVICE #3) WAS NOT SUBMITTED FOR INVESTIGATION. IT WAS REPORTED THE RICHARD WOLF INSTRUMENT (DEVICE #3) WAS EXAMINED BY HOSPITAL BIOMED DEPARTMENT AFTER THE PROCEDURE, AND FOUND TO BE IN PROPER WORKING ORDER. BASED ON INVESTIGATION FINDINGS AND ALL THE INFO RECEIVED THE ROOT CAUSE OF THE INJURY CANNOT BE DETERMINED. THE RESULTS OF OUR INVESTIGATION REVEALED THE RICHARD WOLF INSTRUMENT WORKED AS INTENDED AND BASED ON THESE RESULTS COULD NOT BE THE CAUSE OF THE BURN. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. IE INTENDED USE, INDICATIONS AND FIELD OF USE, PREPARATION AND CAUTIONS. RICHARD WOLF CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVED ADDITIONAL INFO WE WILL PROVIDE FDA WITH FOLLOW-UP INFO. ALSO SEE FOLLOWING REPORT FOR SAME EVENT: 1418479-2012-00006 (DEVICE #1), 1418479-2012-00007 (DEVICE #2), 1418479-2012-00009 (DEVICE #4), 1418479-2012-00010 (DEVICE #5).

    Description of Event or Problem · 1

    PROCEDURE: TRANSURETHRAL RESECTION/VAPORIZATION OF THE PROSTATE. DURING THE PROCEDURE THE ERBE BIPOLAR GENERATOR DISPLAYED ERROR CODE, C21-1. THE RICHARD WOLF SALES REPRESENTATIVE ON HAND SUGGESTED CHANGING OUT THE ELECTRODE TO ENSURE THERE WAS NO ISSUE WITH THE PRODUCT. THERE WAS NO ERBE REPRESENTATIVE PRESENT TO PROVIDE ADVISEMENT ON THE GENERATOR. THE DOCTOR REPLACED THE ELECTRODE, THE ALARM RESET AND THE PROCEDURE CONTINUED. AN ERROR CODE AGAIN DISPLAYED, HOWEVER THE DOCTOR WAS ABLE TO CONCLUDE THE PROCEDURE WITHOUT ANY OTHER ISSUES NOTED. WHEN THE PT AWOKE HE COMPLAINED OF PAIN ON HIS POSTERIOR RIGHT THIGH. AN ASSESSMENT REVEALED A 2X7X8 CM SECOND DEGREE THERMAL BURN. SEVERAL INSTRUMENTS FROM RICHARD WOLF AND A BIPOLAR GENERATOR FROM ERBE WERE USED IN ORDER TO PERFORM THE PROCEDURE ABOVE. ORIGINAL REPORT SUBMITTED ON (B)(6) 2012, ASKED TO SEPARATE DEVICES INTO INDIVIDUAL REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHEATH, RESECTOSCOPE, PROFILE (DEVICE #3) SHEATH OF RESECTOSCOPE FJL RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8655.384

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other