BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 2123231 · Received June 14, 2011

    Report

    Report Number
    3005099803-2011-02105
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 18 YEARS OF AGE. DR. (B)(6) WAS ALSO NOTED AS AN INITIAL REPORTER. (B)(4) - THE REPORTED EVENT OF JAW DETACHED. 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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT ONE JAW WAS ATTACHED TO THE PULL WIRE, BUT NOT RIVETED TO THE CLEVIS. THE OTHER JAW, WASHER, AND EYELET WERE NOT RETURNED FOR EVALUATION. THE UNIT DID NOT PRESENT WITH RIVETING. NO ABNORMALITIES WERE NOTED WITH THE DEVICE WELDING WHICH WAS WITHIN DESIGN SPECIFICATION. FUNCTIONALLY, THE RETURNED UNIT WAS NOT TESTED DUE TO THE RETURN CONDITION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE JAW DETACHED. THE EVALUATION FOUND THAT THE DEVICE WAS IMPROPERLY RIVETED WHICH ALLOWED THE JAWS TO DETACH. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING. AN INVESTIGATION IS UNDERWAY TO ADDRESS RIVETING FAILURES. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 BIOPSY FORCEPS WAS USED DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A TISSUE SAMPLE WAS RETRIEVED. UPON REMOVAL OF THE DEVICE, RESISTANCE WAS FELT. THE PHYSICIAN PUSHED THE JAW DISTAL AND THE DEVICE DISASSEMBLED INTO SINGLE COMPONENTS. THE DEVICE WAS REMOVED FROM THE PATIENT, HOWEVER, THE JAWS REMAINED IN THE ANTRUM OF THE PATIENT. FORCEPS WERE USED TO TRY AND REMOVE THE DETACHED JAWS, HOWEVER THIS ATTEMPT WAS UNSUCCESSFUL. SUBSEQUENTLY A ROTH NET WAS USED SUCCESSFULLY TO RETRIEVE THE JAWS. THE DUODENUM, STOMACH, INVERSION AND HIATAL HERNIA WERE INSPECTED AND NO METAL PARTS WERE VISIBLE. AN X RAY WAS ALSO TAKEN AND USED FOR INSPECTION OF THE ENTIRE STOMACH. IT WAS NOTED THAT INVERSION AND HIATAL HERNIA WERE NOT CAUSED BY THIS EVENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 BIOPSY FORCEPS. ADDITIONALLY, IT WAS NOTED THAT THE DEVICE WAS INSPECTED PRIOR TO USE AND THE DEVICE WAS OK. 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 4 BIOPSY FORCEPS WAS USED DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A TISSUE SAMPLE WAS RETRIEVED. UPON REMOVAL OF THE DEVICE, RESISTANCE WAS FELT. THE PHYSICIAN PUSHED THE JAW DISTAL AND THE DEVICE DISASSEMBLED INTO SINGLE COMPONENTS. THE DEVICE WAS REMOVED FROM THE PATIENT, HOWEVER, THE JAWS REMAINED IN THE ANTRUM OF THE PATIENT. FORCEPS WERE USED TO TRY AND REMOVE THE DETACHED JAWS, HOWEVER THIS ATTEMPT WAS UNSUCCESSFUL. SUBSEQUENTLY A ROTH NET WAS USED SUCCESSFULLY TO RETRIEVE THE JAWS. THE DUODENUM, STOMACH, INVERSION AND HIATAL HERNIA WERE INSPECTED AND NO METAL PARTS WERE VISIBLE. AN X RAY WAS ALSO TAKEN AND USED FOR INSPECTION OF THE ENTIRE STOMACH. IT WAS NOTED THAT INVERSION AND HIATAL HERNIA WERE NOT CAUSED BY THIS EVENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 BIOPSY FORCEPS. ADDITIONALLY, IT WAS NOTED THAT THE DEVICE WAS INSPECTED PRIOR TO USE AND THE DEVICE WAS OK. 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 4 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00513302 0014036808

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention