BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE

    MDR report key: 388329 · Received April 11, 2002

    Report

    Report Number
    MW1024716
    Event Type
    Malfunction
    Date Received
    April 11, 2002
    Date of Event
    October 1, 2000
    Report Date
    April 11, 2002
    Manufacturer
    ERBE USA INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    APC BY ERBE MALFUNCTIONED WHILE WORKING WITH PT IN 04/2002. WHILE TROUBLESHOOTING, NOTED THAT POSSIBLE SHORT OCCURRED AND FLUID WAS COMING FROM GRAY HOSE THAT IS CONNECTED BETWEEN THE MACHINE AND DISPOSABLE PROBE THAT GOES THROUGH ENDOSCOPE. CALLED BIOMED AND VOICED CONCERN THAT ELECTRICAL SHORT HAS OCCURRED AND NEED TO DISINFECT HOSE PRIOR TO USE ON ADD'L PT. BIOMED PERSONNEL CALLED MANUFACTURING CO WHO SAID THEY HAD SENT OUT A LETTER RECOMMENDING DECONTAMINATION OF HOSE BETWEEN PT USE. THEY FAXED A COPY OF THE LETTER. RPTR DIDN'T RECEIVE THIS LETTER PRIOR TO 04/2002. DURING INSERVICE OF THE PRODUCT BY COMPANY REP, NO MENTION MADE OF NEED TO DECONTAMINATE HOSE. HAD 2 SEPARATE INSERVICES FROM 2 DIFFERENT REPS. MANUAL ACCOMPANYING PRODUCT DOES NOT RECOMMEND DECONTAMINATION OF HOSE.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 10/15/02: NEITHER THE ARGON PLASMA COAGULATOR UNIT (MODEL: APC 300) NOR, THE APC CONNECTOR HOSE (P/N: 20132-046) IN QUESTION WERE RETURNED TO ERBE USA, INC. BASED UPON THE INFO PROVIDED BY THE "USER FACILITY," THE PROBLEM ENCOUNTERED WAS THE RESULT OF NOT MAINTAINING (I.E., CLEANING DISINFECTING, ETC.) THE HOSE AS STATED IN THE LABELING (SEE EXHIBIT B). THE EVENTS ARE "UNKNOWN AT THIS TIME" AS STATED ON THE MEDWATCH FORM (SEE EXHIBIT A) AND ARE NOT ATTRIBUTABLE TO THE DEVICE. THE LABELING SUPPLIED WITH THE APC CONNECTOR HOSE DESCRIBED THE METHODS FOR MAINTAINING THE HOSE (I.E., CLEANING, ETC.). IT IS CO'S UNDERSTANDING THAT THE "USER FACILITY" WAS NOT FOLLOWING THESE LABELING RECOMMENDATIONS (SEE EXHIBIT B). IT IS MFR'S UNDERSTANDING THAT THE "USER FACILITY" PERFORMED THE CLEANING, ETC. OF THE HOSE AS REQUIRED BY THE LABELING. UPON PROCESSING THE HOSE, NO FURTHER PROBLEM WITH THE UNIT OR THE HOSE WAS REPORTED FROM THE FACILITY. IT APPEARS THAT THE EQUIPMENT WAS PLACED BACK INTO SVC. NO DESIGN CHANGES OCCURRED TO THE ARGON PLASMA COAGULATOR UNIT (MODEL: APC 300) OR THE APC CONNECTOR HOSE THAT ARE RELATED TO THE EVENT. THE APC CONNECTOR HOSE HAS A SEPARATE LABELING FROM THE ARGON PLASMA COAGULATOR UNIT THAT IS PLACED WITH THE HOSE. IT DESCRIBES THE METHODS FOR MAINTAINING THE HOSE (I.E., CLEANING, ETC.) AND THEY WERE RECEIVED BY THE "USER FACILITY" AT THEIR "PURCHASE DATE" (SHOWN BY ERBE RECORDS) OF 6/9/00. IN ADDITION MEMOS FROM MFR'S CLINICAL GROUP WERE DEVELOPED AND SENT TO CUSTOMERS REINFORCING THE LABELING REQUIREMENTS ON 8/30/01 AND 10/19/01 (SEE EXHIBIT B).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE ARGON PLASMA COAGULATOR GEI ERBE USA INC APC 300 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other