BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPSYS MARKER CLIP WITH INTRODUCER

    MDR report key: 186162 · Received September 8, 1998

    Report

    Report Number
    1527736-1998-02703
    Event Type
    Injury
    Date Received
    September 8, 1998
    Date of Event
    May 19, 1998
    Product Code
    KNW
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    A FAX WAS SENT ON 07/01/1998 FROM A FACILITY REQUESTING TRAINING COURSE INFO ON THE BIOPSYS MAMMOTOME BREAST BIOPSY SYSTEM. UPON FURTHER INVESTIGATION IT WAS DISCOVERED A PRODUCT INQUIRY HAD BEEN REPORTED TO BIOPSYS BY THE REP ON 05/19/1998 (CER # 980772) REGARDING AN EVENT THAT OCCURRED ON 05/19/1998. THIS REPORT WAS FAXED TO BIOPSYS. THE REPORT READ "DURING THE DEPLOYMENT OF A MICROMARK CLIP RESISTANCE WAS FELT DURING RETRACTION." "THE SLEEVE DETACHED AND REMAINED IN THE PT'S BREAST." "IT WAS IMMEDIATELY REMOVED WITH TWEEZERS." "REP REPORTS THE TECH DEPLOYED THE CLIP AFTER THE RADIOLOGIST LEFT THE ROOM." "THIS WAS THE THIRD CLIP ATTEMPTED FOR DEPLOYMENT." "UPON EXAMINATION PART OF THE ULTEM TUBE WAS CLEARLY SLICED OFF WITH THE SLEEVE." "PRODUCT TO REMAIN WITH RISK MANAGEMENT DEPT AT THE HOSP." "CUSTOMER CLAIMS THAT AFTER 2 CLIPS DIDN'T DEPLOY ON THE 3RD CLIP ATTEMPT THE SLEEVE DETACHED AND WAS LEFT IN THE PT'S BREAST." "THEY LATER REMOVED SLEEVE WITH TWEEZERS." "NO PRODUCT TO BE RETURNED." A MEDWATCH REPORT WAS REC'D ON 09/01/1998 AND IT READS "AFTER DEPLOYING THE CLIP, THE GUIDE WAS RETRACTED AND THE METAL TIP APPARENTLY BROKE OFF, LEAVING ABOUT 10MM INTO THE BREAST." "PT HAD TO GO TO THE EMERGENCY ROOM FOR REMOVAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPSYS MARKER CLIP WITH INTRODUCER BIOPSYS KNW NA

    Patients

    Seq Age Sex Outcome Treatment
    1