BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1813616 · Received August 25, 2010

    Report

    Report Number
    3005099803-2010-03638
    Event Type
    Malfunction
    Date Received
    August 25, 2010
    Date of Event
    May 12, 2010
    Report Date
    August 2, 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

    (B)(4):THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON 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)

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO ABNORMALITIES AND THE DEVICE WAS WITHIN SPECIFICATIONS. SIMILARLY, THE RETURNED UNIT WAS FUNCTIONALLY TESTED AND IT PERFORMED ACCORDING TO SPECIFICATIONS. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT; THAT THE JAWS WON'T CLOSE. THE MOST PROBABLE ROOT CAUSE COULD NOT BE CONFIRMED AS THE RETURNED DEVICE WAS WITHIN MANUFACTURING SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS WAS USED DURING A LARGE INTESTINE BIOPSY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO OPEN AND CLOSE CORRECTLY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 GOOD. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS WAS USED DURING A LARGE INTESTINE BIOPSY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO OPEN AND CLOSE CORRECTLY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 GOOD. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00515360 13228082

    Patients

    Seq Age Sex Outcome Treatment
    1