BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1911813 · Received December 1, 2010

    Report

    Report Number
    3005099803-2010-04987
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS UNKNOWN; HOWEVER REPORTED TO BE OVER 18 YEARS OLD. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS STANDARD CAPACITY WAS USED DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE JAWS OF THE DEVICE COULD NOT CLOSE. IT WAS NOTICED THAT THE PULL-WIRE WAS BENT. THERE WAS NO DIFFICULTY OR RESISTANCE INSERTING THE DEVICE INTO THE SCOPE, HOWEVER RESISTANCE WAS FELT WHILE REMOVING THE DEVICE FROM THE SCOPE. THE SCOPE AND FORCEPS WERE REMOVED IN TANDEM FROM THE PATIENT AND THE FORCEPS WAS THEN CUT TO BE REMOVED FROM THE SCOPE. THE PROCEDURE WAS COMPLETED WITH THIS RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS STANDARD CAPACITY DEVICE. REPORTEDLY THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. 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.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1