BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW HOT SINGLE-USE BIOPSY FORCEPS

    MDR report key: 2143166 · Received June 28, 2011

    Report

    Report Number
    3005099803-2011-02237
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    KGE
    PMA / PMN Number
    K910964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT ID, AGE, GENDER AND WEIGHT ARE UNKNOWN. IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18 YEARS. COMMED BEAMER GENERATOR. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 FOUND THE RETURN UNIT TO BE WITHIN SPECIFICATION. NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING OR WELDING. FUNCTIONALLY, THE UNIT WAS ABLE TO BE OPENED AND CLOSED WITHOUT ISSUE. ADDITIONALLY, A RESISTANCE TEST WAS PERFORMED AND THE UNIT MET SPECIFICATION. THE CONDITION OF THE RETURNED INCIDENT DEVICE SHOWED NO EVIDENCE OF THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. 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

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW HOT SINGLE USE BIOPSY FORCEPS DEVICE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE NURSE AND PHYSICIAN WERE UNABLE TO CONNECT THE ACTIVE CORD TO THE BIOPSY FORCEPS. THE CONNECTOR WAS REPORTED AS BEING INTACT AND NOT LOOSE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW HOT SINGLE USE BIOPSY FORCEPS DEVICE USING THE SAME NON-BSC ACTIVE CORD. ADDITIONALLY, THE USER REPORTED THAT THE DEVICE WAS NOT DAMAGED UPON REMOVAL FROM PACKAGING AND NO PACKAGING DAMAGE WAS VISIBLE. 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 HOT SINGLE USE BIOPSY FORCEPS DEVICE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE NURSE AND PHYSICIAN WERE UNABLE TO CONNECT THE ACTIVE CORD TO THE BIOPSY FORCEPS. THE CONNECTOR WAS REPORTED AS BEING INTACT AND NOT LOOSE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW HOT SINGLE USE BIOPSY FORCEPS DEVICE USING THE SAME NON-BSC ACTIVE CORD. ADDITIONALLY, THE USER REPORTED THAT THE DEVICE WAS NOT DAMAGED UPON REMOVAL FROM PACKAGING AND NO PACKAGING DAMAGE WAS VISIBLE. 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 HOT SINGLE-USE BIOPSY FORCEPS FORCEPS, BIOPSY, ELECTRIC KGE BOSTON SCIENTIFIC - COSTA RICA M00515500 14112039

    Patients

    Seq Age Sex Outcome Treatment
    1