BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 2160108 · Received July 13, 2011

    Report

    Report Number
    3005099803-2011-02303
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    April 18, 2011
    Report Date
    June 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE CATHETER CUT, CLEVIS ARMS BENT AND ONE JAW WAS BENT. RIVETING AND WELDING MARKS WERE WITHIN SPECIFICATION. RING GAGE FAILED, DUE TO THE BENT CLEVIS ARMS. THE DEVICE COULD NOT BE FUNCTIONALLY TESTED DUE TO THE PRESENT CONDITION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT OF THE DEVICE COULD NOT BE REMOVED FROM THE SCOPE. THE BENT CLEVIS ARMS AND THE BENT JAW COULD INTERFERE WITH DEVICE WITHDRAWAL FROM THE SCOPE. THE MOST PROBABLE CAUSE IS OPERATIONAL CONTEXT. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 BIOPSY FORCEPS WAS USED DURING A BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN GRASPED THE TISSUE AND THEN WAS UNABLE REMOVE THE DEVICE FROM THE SCOPE. THE BIOPSY FORCEPS AND SCOPE WERE REMOVED IN TANDEM FROM THE PATIENT. THE TIP OF THE DEVICE WAS CUT AND THE DEVICE WAS REMOVED FROM THE SCOPE. THE SCOPE WAS REINTRODUCED INTO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 BIOPSY FORCEPS. REPORTEDLY, THERE WERE NO VISIBLE ISSUES WITH THE FORCEPS DEVICE. ADDITIONALLY, AFTER THE BIOPSY WAS TAKEN, THE JAWS WERE ABLE TO BE CLOSED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; JAW BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 4 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00513381 13699870

    Patients

    Seq Age Sex Outcome Treatment
    1