BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW¿ 3

    MDR report key: 2143159 · Received June 28, 2011

    Report

    Report Number
    3005099803-2011-02247
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Report Date
    June 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    KGE
    PMA / PMN Number
    K910964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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).

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO VISIBLE ISSUES. FUNCTIONALLY, THE JAWS WERE ABLE TO BE OPENED AND CLOSED WITHOUT ISSUE. A DIMENSIONAL ANALYSIS WAS PERFORMED OF THE JACKET AND CLEVIS OUTER DIAMETER; ALL MEASUREMENTS WERE WITHIN SPECIFICATION. THE CONDITION OF THE RETURNED INCIDENT DEVICE SHOWED NO EVIDENCE OF THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THE COMPLAINT WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 HOT SINGLE-USE BIOPSY FORCEPS WAS USED DURING A COLONOSCOPY PROCEDURE . ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FORCEPS WERE DIFFICULT TO ADVANCE DOWN THE WORKING CHANNEL OF THE SCOPE. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT THE JAWS WERE "JAMMED" OPEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 HOT SINGLE-USE BIOPSY FORCEPS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 HOT SINGLE-USE BIOPSY FORCEPS WAS USED DURING A COLONOSCOPY PROCEDURE . ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FORCEPS WERE DIFFICULT TO ADVANCE DOWN THE WORKING CHANNEL OF THE SCOPE. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT THE JAWS WERE "JAMMED" OPEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 HOT SINGLE-USE BIOPSY FORCEPS 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¿ 3 FORCEPS, BIOPSY, ELECTRIC KGE BOSTON SCIENTIFIC - COSTA RICA M00515501 14237790

    Patients

    Seq Age Sex Outcome Treatment
    1