BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON-ENDO SURGERY, INC.

    MDR report key: 503142 · Received December 12, 2003

    Report

    Report Number
    MW1030544
    Event Type
    Malfunction
    Date Received
    December 12, 2003
    Date of Event
    December 11, 2003
    Report Date
    December 12, 2003
    Manufacturer
    ETHICON-ENDO SURGERY, INC.
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PROCEDURE RIGHT STEREOTACTIC BREAST BIOPSY WITH MAMMOTOME MACHINE. ETHICON ENDO-SURGERY, INC. MAMMOMTOME ST STEREOTACTIC PROBE 11 GAUGE, HAS A VACUUM SET ATTACHED TO IT AT 2 DIFFERENT SITES. IN MID PROCEDURE THE SITE OF VACUUM INSERTION TO PROBE SNAPPED AND BROKE OFF. THE PROCEDURE HAD TO BE HALTED. NEEDLE REMOVED FROM PT'S BREAST. PRESSURE APPLIED TO SITE WHILE CHANGING PROBE AND VACUUM SET.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 4/13/2004: THERE WAS NO DOCUMENTATION IN SYSTEM REFERRING TO THIS INCIDENT. THE ACCOUNT WAS CONTACTED AND THE ACCOUNT STATED THAT THEY HAD REPORTED THE EVENT TO THE FDA AND NOT EES. MFR HAS ENTERED THE INFO FOR THE MST11 LOT #R4UZ73 AND MSET LOT #03A133 PROVIDED FROM YOUR REPORT INTO MFR'S SYSTEM AND ASSIGNED IT SR #362683-0. IT HAS BEEN DOCUMENTED IN THE FILE SR #362683-0 THAT THE ACCOUNT NURSE HAD AGREED DURING THE IN-SERVICE WITH THE EES SALE REP THAT THEY HAD BEEN POSITIONING THE SYSTEM TOO FAR FROM THE FISHER TABLE DURING FIRING OF THE PROBE. THIS POSITION CAUSED THE VACUUM INSERTION TUBE TO THE PROBE TO SNAP AND BREAK OFF. IN ADDITION A SECOND MST11 PROBE WAS USED TO COMPLETE THE CASE SUCCESSFULLY. THERE WAS NO CONSEQUENCE TO THE PT AND THE PT WAS RELEASED IN NORMAL POST OP CONDITION. IT WAS CONFIRMED BY THE ACCOUNT THAT THE MST11 WAS DISPOSED OF AFTER THE PROCEDURE AT THE ACCOUNT. THIS ISSUE WAS DISCUSSED DURING THE IN-SERVICE AND AGREED UPON THAT THIS WAS A USER ERROR AND HAS BEEN CORRECTED BY ADD'L TRAINING DURING THE REPS IN-SERVICE. THERE WAS NO PRODUCT RETURNED FOR EVALUATION AND ANALYSIS THEREFORE THERE ARE NO CONCLUSIONS AS TO WHAT MAY HAVE CAUSED THE EVENT FROM THAT PROCESS. A LOT HISTORY REVIEW HAS BEEN DONE AND NOTED IN THE ATTACHED SR ANALYSIS REPORT #362683-0. THERE HAS BEEN NO MEDWATCH FILED AS THIS COMPLAINT DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT AND CONSIDERED NOT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON-ENDO SURGERY, INC. STEREOTACTIC PROBE 11 GAUGE HAW ETHICON-ENDO SURGERY, INC. * R4UZ73
    2 ETHICON-ENDO SURGERY, INC. VACUUM SET MAMMOTOME FCK ETHICON-ENDO SURGERY, INC. * 03A133

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other