BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW¿ 3

    MDR report key: 2221029 · Received August 23, 2011

    Report

    Report Number
    3005099803-2011-02900
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    April 26, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE CLEVIS ARMS WERE BENT AND THE COIL WAS ELONGATED AT THE DISTAL END. NO BROKEN OR FRACTURED COMPONENTS WERE FOUND DURING EXAMINATION, AND THE DEVICE RIVETING AND CRIMPING WERE WITHIN SPECIFICATIONS. FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. ADDITIONALLY, A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT SINCE NO FRACTURED/BROKEN COMPONENTS WERE FOUND. HOWEVER DURING DEVICE EVALUATION IT WAS FOUND THAT THE CLEVIS ARMS WERE BENT AND THE COIL WAS ELONGATED. SINCE THERE ARE CONTROLS IN THE MANUFACTURING PROCESS THAT VERIFY PRODUCT INTEGRITY, AND DUE TO THE LACK OF EVIDENCE IDENTIFYING THE USE OF THE DEVICE, THE SPECIFIC CAUSE OF THE FAILURE CANNOT BE IDENTIFIED.(B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS UNKNOWN; HOWEVER REPORTED TO BE OVER 18 YEARS OLD (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).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS WAS TO BE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING UNPACKING FOR THE PROCEDURE, IT WAS NOTED THAT THE FORCEPS WAS BROKEN. NO FURTHER CLARIFICATION/INFORMATION COULD BE PROVIDED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS WAS TO BE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011.ACCORDING TO THE COMPLAINANT, DURING UNPACKING FOR THE PROCEDURE, IT WAS NOTED THAT THE FORCEPS WAS BROKEN. NO FURTHER CLARIFICATION/INFORMATION COULD BE PROVIDED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW¿ 3 FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00515361 13970384

    Patients

    Seq Age Sex Outcome Treatment
    1