BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1792126 · Received August 10, 2010

    Report

    Report Number
    3005099803-2010-03496
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE NEEDLE WAS BENT. FUNCTIONALLY, THE DEVICE JAWS WERE ABLE TO BE OPENED, BUT FAILED TO CLOSE PROPERLY DUE TO THE BENT NEEDLE. THE WELDING MARKS WERE EVALUATED AND FOUND TO BE WITHIN SPECIFICATION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE WOULD NOT CLOSE. BASED ON THE EVALUATION, THE NEEDLE WAS FOUND TO BE BENT WHICH PREVENTED PROPER CLOSURE OF THE JAWS. THE DFU INDICATES THAT THE DEVICE SHOULD BE INSPECTED PRIOR TO USE AND THAT EXCESSIVE FORCE SHOULD BE AVOIDED WHEN HANDLING THE DEVICE. SINCE THE SPECIFIC CAUSE OF THE FAILURE CANNOT BE IDENTIFIED, THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE. 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. A LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4) (WON'T CLOSE). 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 4 SINGLE USE BIOPSY FORCEPS LARGE CAPACITY WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2010 ACCORDING TO THE COMPLAINANT, DURING UNPACKING THE DEVICE WAS REMOVED FROM THE PRODUCT PACKAGING AND THE NEEDLE WAS FOUND BENT, INHIBITING THE JAWS/CUPS FROM CLOSING. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS LARGE CAPACITY 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 4 SINGLE USE BIOPSY FORCEPS LARGE CAPACITY WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2010 ACCORDING TO THE COMPLAINANT, DURING UNPACKING THE DEVICE WAS REMOVED FROM THE PRODUCT PACKAGING AND THE NEEDLE WAS FOUND BENT, INHIBITING THE JAWS/CUPS FROM CLOSING. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS LARGE CAPACITY 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 4 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00513331 13334735

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR