BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISCHER CONE BIOPSY EXCISOR

    MDR report key: 1379377 · Received June 16, 2006

    Report

    Report Number
    1221923-2006-00001
    Event Type
    Malfunction
    Date Received
    June 16, 2006
    Date of Event
    May 15, 2006
    Report Date
    May 25, 2006
    Manufacturer
    APPLE MEDICAL CORP.
    Product Code
    KNW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT INVOLVED THREE (3) FISCHER CONE BIOPSY EXCISORS (FCBE), TWO (2) MEDIUM AND ONE (1) MEDIUM-EXTENDED, FROM THREE (3) DIFFERENT LOTS MANUFACTURED OVER A TEN (10) MONTH PERIOD. ALL PRODUCTS FROM THESE THREE (3) LOTS WERE DISTRIBUTED TO USER FACILITIES OVER NINE (9) MONTHS AGO. THIS EVENT IS THE FIRST AND ONLY EVENT REPORTED THAT INVOLVED THE "MEDIUM" SIZE FCBE'S. A PRODUCT COMPLAINT RECEIVED IN SEPT 2005 INVOLVING ANOTHER MEDIUM-EXTENDED FCBE FROM LOT #L074Q. THIS PREVIOUS COMPLAINT, INVOLVED A SIMILAR TYPE FAILURE OF THE FCBE WHEN IT WAS SUBJECTED TO APPROX. TWICE THE RECOMMENDED POWER SETTING. THE FCBE DESIGN HAS BEEN VALIDATED BY TESTING TO THE TWO STANDARDS THAT COVER ELECTROSURGICAL UNITS (ESUS) AND THEIR ACCESSORIES; ANSI/AAMI HF18 AND IEC 60601-2-2. IN ADDITION, EACH FCBE UNDERGOES A TOP ASSEMBLY VALIDATION HYPO TEST. THE DIRECTIONS FOR USE (DFU) FOR THE FCBE PRESCRIBES ESU SETTINGS THAT ARE BASED ON DEVICE DESIGN. HOWEVER, IF THE FCBE IS OPERATED UNDER CONDITIONS THAT EXCEED THE DESIGN BASIS, THE FCBE MAY FAIL IN A MANNER CONSISTENT WITH THIS REPORTED FAILURE. OPERATION BEYOND THE DESIGN BASIS MAY BE INTENTIONAL OR UNINTENTIONAL DUE TO A FAULTY OR OUT OF CALIBRATION ESU. THE CIRCUMSTANCES OF THIS EVENT SUGGEST THAT THE TWO DIFFERENT FCBE DEVICES WERE OPERATED BEYOND THEIR DESIGN BASIS. APPLE MEDICAL WILL IN-SERVICE THE FACILITY IN THE PROPER USE OF THE FCBE. ADD'L MODEL#S: MEDIUM EXT., MEDIUM. ADD'L CATALOG#S: 900-154, 9001-151. ADD'L LOT#: D094L, H095M. ADD'L EXPIRATION DATES: 08/31/2008, 02/28/2008. ADD'L MFR DATES: 04/30/2004, 02/28/2005.

    Description of Event or Problem · 1

    RPTR FROM HOSP CALLED APPLE MEDICAL TO REPORT THE MALFUNCTION OF THREE FISCHER CONE BIOPSY EXCISORS (FCBE'S), A DEVICE MANUFACTURED BY APPLE. RPTR REPORTED THAT THE "WIRE BROKE AND INSULATION MELTED" ON THE THREE FCBE'S WHILE IN USE DURING THE SAME PROCEDURE OCCURRING IN MID-MAY. APPLE MEDICAL DISPATCHED REP TO MEET WITH RPTR AT THE FACILITY IN AN EFFORT TO DETERMINE WHY THE FCBE'S HAD FAILED. REP VISITED THE FACILITY IN 2006 AND A SUMMARY OF REP FINDINGS FOLLOWING THEIR VISIT CAN BE FOUND ON THE ATTACHED PAGE THREE (3) OF THIS FORM. REP MET WITH RPTR, COORDINATOR - O.R. MATERIALS, AND, O.R. NURSE, IN 2006 AT THE HOSPITAL ( MEDICAL CENTER). RPTR DESCRIBED THREE (3) SUCCESSIVE FCBE FAILURES DURING A PROCEDURE BEING DONE BY DR. AT FACILITY. ACCORDING TO RPTR AND THE NURSE, FACILITY HAS BEEN USING THE FCBE PRODUCT FOR "SIX OR SEVEN YEARS" AND UNTIL THE LAST THREE (3) MONTHS HAD NOT EXPERIENCED A FAILURE. ABOUT THREE (3) MONTHS AGO, DR. WAS TAKING A SAMPLE WHEN THE FISCHER WIRE "SNAPPED". A SECOND FISCHER WAS USED TO SUCCESSFULLY FINISH THE PROCEDURE. NO FURTHER ACTION WAS TAKEN. THEN, IN MID-MAY, DR., D.O. HAD MULTIPLE FAILURES AND FINISHED THE PROCEDURE USING ANOTHER EXCISOR. THE NURSE REPORTED THAT THEY, THE FACILITY, WAS USING ALL NEW "BOVIE'S" (A GENERIC REFERENCE TO AN ELECTROSURGICAL UNIT - ESU), WHICH WERE DETERMINED TO BE VALLEY LAB FORCE EZ TYPE GENERATORS BY REP. THE NURSE ASSISTING DR. IN THE PROCEDURE REPORTED THAT THE ESU WAS SET TO 60 WATTS IN BOTH THE "CUT" AND "COAG" MODES. REP LEARNED THAT SIXTY (60) WATTS IS A TYPICAL SETTING USED BY THE HOSPITAL FOR SOME NON-APPLE ELECTRODES, BUT EXCEEDS THE RECOMMENDED SETTINGS FOUND ON THE FISCHER DIRECTIONS FOR USE (DFU) BY TEN (10) TO TWENTY-FIVE (25) WATTS DEPENDENT ON THE SIZE OF THE FCBE BEING USED. REP GAVE THE FACILITY A COPY OF OUR FCBE DFU, CD VIDEOS ON THE USE OF THE FCBE, SEVERAL PUBLISHED STUDIES ON THE FCBE AND A RECOMMENDATION NOT TO EXCEED 50 WATTS WHEN USING THE FISCHER DEVICE. THE FAILED FCBE ELECTRODES WERE RETURNED WERE RETURNED TO APPLE FOR EVAL AND A VISUAL OBSERVATION REVEALED BROKEN WIRE ELECTRODES AND NOMINAL CARBONIZATION/CHARRING (NOMINAL "CHARRING" IS TYPICAL AND IS SOMETIMES INCORRECTLY AS "MELTING"). THE PRODUCT WAS REPLACED BY APPLE MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FISCHER CONE BIOPSY EXCISOR BIOPSY INSTRUMENT KNW APPLE MEDICAL CORP. MED. L074Q

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN