BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1932920 · Received December 20, 2010

    Report

    Report Number
    3005099803-2010-05174
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE WEIGHT OF THE PATIENT IS UNKNOWN. 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 NEEDLE WAS BENT. FUNCTIONALLY, THE DEVICE JAWS WOULD OPEN NORMALLY, BUT FAILED TO CLOSE PROPERLY DUE TO THE BENT NEEDLE CONDITION. NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING AND WELDING WHICH WERE WITHIN SPECIFICATION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE NEEDLE WAS BENT. THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE DUE TO THE LACK OF EVIDENCE IDENTIFYING THE USE OF THE DEVICE. 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 BIOPSY FORCEPS WAS USED DURING A BIOPSY OF THE COLON PROCEDURE, PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE DIFFICULTY WAS EXPERIENCED WHEN ADVANCING AND WITHDRAWING THE DEVICE FROM THE SCOPE. UPON REMOVAL OF THE DEVICE FROM THE SCOPE, IT WAS NOTED THAT THE NEEDLE WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 BIOPSY FORCEPS. POST PROCEDURE IT WAS NOTED THAT THE SCOPE HAD A LEAK. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 BIOPSY FORCEPS WAS USED DURING A BIOPSY OF THE COLON PROCEDURE, PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE DIFFICULTY WAS EXPERIENCED WHEN ADVANCING AND WITHDRAWING THE DEVICE FROM THE SCOPE. UPON REMOVAL OF THE DEVICE FROM THE SCOPE, IT WAS NOTED THAT THE NEEDLE WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 BIOPSY FORCEPS. POST PROCEDURE IT WAS NOTED THAT THE SCOPE HAD A LEAK. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    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 M00515373 0013738781

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR