BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1994035 · Received February 16, 2011

    Report

    Report Number
    3005099803-2011-00394
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE NEEDLE WAS TILTED, BUT THE JAWS WERE NOT BENT. FUNCTIONALLY, THE FORCEPS OPENED AND CLOSED WITHIN SPECIFICATION. ADDITIONALLY, NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING AND WELDING WHICH WERE WITHIN DESIGN SPECIFICATION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE JAWS WERE BENT. 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).

    Additional Manufacturer Narrative · 1

    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 BIOPSY FORCEPS WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A BIOPSY WAS TAKEN SUCCESSFULLY FROM THE STOMACH. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE JAWS APPEARED TO BE BENT AND WOULD NOT OPEN. THE JAWS WERE PRIED OPEN WITH A NEEDLE AND THE BIOPSY SPECIMEN WAS RELEASED. THE JAWS WERE TESTED AFTER THE SPECIMEN WAS RELEASED AND THE JAWS WOULD NOT OPEN OR CLOSE SMOOTHLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 BIOPSY FORCEPS. 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 BIOPSY FORCEPS WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A BIOPSY WAS TAKEN SUCCESSFULLY FROM THE STOMACH. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE JAWS APPEARED TO BE BENT AND WOULD NOT OPEN. THE JAWS WERE PRIED OPEN WITH A NEEDLE AND THE BIOPSY SPECIMEN WAS RELEASED. THE JAWS WERE TESTED AFTER THE SPECIMEN WAS RELEASED AND THE JAWS WOULD NOT OPEN OR CLOSE SMOOTHLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 BIOPSY FORCEPS. 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 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00515993 13842989

    Patients

    Seq Age Sex Outcome Treatment
    1