BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 2062785 · Received April 19, 2011

    Report

    Report Number
    3005099803-2011-01268
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4): 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 BIOPSY FORCEPS WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A BIOPSY WAS OBTAINED FROM THE ESOPHAGUS. HOWEVER, THE FORCEPS DID NOT CLOSE PROPERLY, RESULTING IN A TEAR OF THE ESOPHAGEAL MUCOSA. NO INTERVENTION WAS REQUIRED TO TREAT THE TEAR, AND IT WAS NOTED THAT NO BLEEDING OCCURED AS A RESULT OF THIS EVENT. THE PHYSICIAN WAS ABLE TO REMOVE THE FORCEPS AND THE SAMPLE WITH NO DAMAGE TO THE SCOPE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. ADDITIONALLY IT WAS NOTED THAT THE ANATOMY OF THE PATIENT WAS NOT TORTUOUS AND THE DEVICE WAS INSPECTED AND TESTED PRIOR TO USE AND NO ANOMALIES WERE FOUND WITH THIS DEVICE. 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 FINE.

    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 M00513412

    Patients

    Seq Age Sex Outcome Treatment
    1