BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 2072008 · Received April 28, 2011

    Report

    Report Number
    3005099803-2011-01431
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO ABNORMALITIES AND THE DEVICE WAS WITHIN SPECIFICATION. ADDITIONALLY, THE RETURNED UNIT PASSED FUNCTIONAL TESTING. NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING AND WELDING. THE CONDITION OF THE RETURNED INCIDENT DEVICE SHOWED NO EVIDENCE OF THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. ADDITIONALLY, THE ACCOUNT WAS UNABLE TO CONFIRM WHETHER THE CORRECT DEVICE WAS RETURNED FOR EVALUATION. THE COMPLAINT WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4):THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, 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 A ESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE A BIOPSY WAS RETRIEVED. AS THE FORCEPS WERE BEING WITHDRAWN INTO THE SCOPE IT WAS NOTED THAT THE JAWS WERE BENT TO THE RIGHT AND THE NEEDLE OF THE FORCEPS WAS PROTRUDING FROM THE JAWS. THE FORCEPS WERE REMOVED FROM THE PATIENT. OUTSIDE THE PATIENT, THEY WERE UNABLE TO OPEN THE FORCEPS IN ORDER TO RETRIEVE THE BIOPSY SAMPLE FROM THE JAWS. A NEEDLE WAS USED TO PRY THE JAWS OPEN AND THE SAMPLE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 BIOPSY FORCEPS. POST PROCEDURE IT WAS REPORTED THAT THERE WAS A HOLE IN THE SCOPE. ADDITIONALLY, IT WAS NOTED THAT THE DEVICE WAS INSPECTED AND TESTED PRIOR TO USE AND NO ANOMALIES WERE FOUND. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 BIOPSY FORCEPS WAS USED DURING A ESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE A BIOPSY WAS RETRIEVED. AS THE FORCEPS WERE BEING WITHDRAWN INTO THE SCOPE IT WAS NOTED THAT THE JAWS WERE BENT TO THE RIGHT AND THE NEEDLE OF THE FORCEPS WAS PROTRUDING FROM THE JAWS. THE FORCEPS WERE REMOVED FROM THE PATIENT. OUTSIDE THE PATIENT, THEY WERE UNABLE TO OPEN THE FORCEPS IN ORDER TO RETRIEVE THE BIOPSY SAMPLE FROM THE JAWS. A NEEDLE WAS USED TO PRY THE JAWS OPEN AND THE SAMPLE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 BIOPSY FORCEPS. POST PROCEDURE IT WAS REPORTED THAT THERE WAS A HOLE IN THE SCOPE. ADDITIONALLY, IT WAS NOTED THAT THE DEVICE WAS INSPECTED AND TESTED PRIOR TO USE AND NO ANOMALIES WERE FOUND. 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 M00513332 13995942

    Patients

    Seq Age Sex Outcome Treatment
    1