BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 2063446 · Received April 19, 2011

    Report

    Report Number
    3005099803-2011-01319
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    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 THAT THE JAWS AND NEEDLE WERE DETACHED AND ONE OF THE CLEVIS ARMS WAS BENT. THE DETACHED COMPONENTS WERE NOT RETURNED FOR EVALUATION. NO RIVETING WAS PRESENT ON THE DEVICE. NO ABNORMALITIES WERE NOTED TO THE DEVICE WELDING WHICH WAS WITHIN SPECIFICATION. FUNCTIONALLY, THE RETURNED UNIT WAS NOT TESTED DUE TO THE RETURN CONDITION. EXTERNAL ANALYSIS OF THE CLEVIS FOUND NO MATERIAL ANOMALIES, AND THE BEND WAS ATTRIBUTED TO AN OVERLOAD. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT; JAW AND NEEDLE DETACHMENT. THE EVALUATION ATTRIBUTED THIS FAILURE TO IMPROPER RIVETING. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING. AN INVESTIGATION WAS PERFORMED TO ADDRESS THIS ISSUE AND A CORRECTION HAS BEEN IMPLEMENTED. THE REPORTED LOT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THIS CORRECTION. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. 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 4 SINGLE USE BIOPSY FORCEPS LARGE CAPACITY WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FORCEPS NEEDLE AND BOTH CUPS FELL OFF THE END OF THE CATHETER AND INTO THE PATIENT WHILE OPENING THE FORCEPS. THE PIECES WERE RETRIEVED THE PIECES WITH ANOTHER RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS LARGE CAPACITY DEVICE AND THE PROCEDURE WAS COMPLETED WITH THAT SECOND DEVICE. REPORTEDLY THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. 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 SINGLE USE BIOPSY FORCEPS LARGE CAPACITY WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FORCEPS NEEDLE AND BOTH CUPS FELL OFF THE END OF THE CATHETER AND INTO THE PATIENT WHILE OPENING THE FORCEPS. THE PIECES WERE RETRIEVED THE PIECES WITH ANOTHER RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS LARGE CAPACITY DEVICE AND THE PROCEDURE WAS COMPLETED WITH THAT SECOND DEVICE. REPORTEDLY THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. 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 M00513331 13951748

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention