BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 SINGLE USE GIOPSY FORCEPS

    MDR report key: 1170603 · Received September 16, 2008

    Report

    Report Number
    3005099803-2008-04606
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE EVAL IS NOT AVAILABLE; THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 22, 2008, THAT A RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS WAS USED DURING A COLONOSCOPY ON EIGHT DAYS EARLIER. ACCORDING TO THE COMPLAINANT, ONE JAW BROKE INSIDE THE WORKING CHANNEL OF THE COLONOSCOPE. ALTHOUGH NUMEROUS ATTEMPTS WERE MADE TO OBTAIN ADD'L INFO ON THE OUTCOME OF THE EVENT, THE PROCEDURE OUTCOME IS UNK. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "NORMAL" WITH NO CLINICAL CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 SINGLE USE GIOPSY FORCEPS FCL BOSTON SCIENTIFIC CORPORATION M00515362 11632309

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK