BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERBOTOM ICC 200 E/A

    MDR report key: 1025910 · Received April 4, 2008

    Report

    Report Number
    9610614-2008-00005
    Event Type
    Other
    Date Received
    April 4, 2008
    Date of Event
    March 14, 2008
    Report Date
    April 4, 2008
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K933157
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU AND ITS FOOTSWITCH AS WELL AS BICAP ADAPTER WERE RETURNED AND THOROUGHLY INSPECTED/TESTED. THE EVALUATION INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK OF THE ESU. THE GENERATOR WAS/IS WITHIN SPECIFICATIONS AND ALL FEATURES WERE/ARE FUNCTIONING PROPERLY. THE FOOTSWITCH AND BICAP ADAPTER WERE ALSO CHECKED AND FOUND TO BE WORKING AS INTENDED. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORDS (DHRS). IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE REPORTED SETTINGS WERE TYPICAL FOR THE CLINICAL APPLICATION. POST PROCEDURAL BLEEDING IS A COMMON COMPLICATION OF POLYPECTOMY PROCEDURES. MOST LIKELY THERE WERE MANY FACTORS INVOLVED WITH THE SITUATION (FOR EXAMPLE, THE PT'S CONDITION, ETC). HOWEVER, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF TH EVENT. THE CUSTOMER IS BEING NOTIFIED OF OUR FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADD'L IN-SERVICE WORK WAS PERFORMED AT THEIR FACILITY ON 3/28/08. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS INCIDENT. ERBE USA, INC IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THAT THE ELECTROSURGICAL UNIT (ESU/GENERATOR) WAS INVOLVED IN A PT INCIDENT. A POLYPECTOMY WAS PERFORMED ON A PT. THE SETTINGS WERE ENDOCUT, EFFECT 3 AT 200 WATTS. THE PHYSICIAN THOUGHT THAT THE UNIT WAS "BURNING TOO HOT". LATER THE PT EXPERIENCED POST PROCEDURAL BLEEDING; THEREFORE, SHE WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION. NO FURTHER ISSUES INVOLVING THE PT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBOTOM ICC 200 E/A ELECTROSURGICAL GENERATOR GEI ERBE ELEKTROMEDIZIN GMBH ICC 200 E/A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization