BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 2031443 · Received March 28, 2011

    Report

    Report Number
    3005099803-2011-01012
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT ONE JAW WAS DEFORMED AND BENT. FUNCTIONALLY, THE RETURNED DEVICE PRESENTED THE OPEN AND CLOSE MOVEMENT. NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING AND WELDING WHICH WERE WITHIN SPECIFICATIONS. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE JAWS WERE BENT. SINCE THERE ARE CONTROLS IN THE MANUFACTURING PROCESS THAT VERIFY PRODUCT INTEGRITY, AND SINCE THE DEVICE COLLECTED BIOPSY SAMPLES PRIOR TO THE FAILURE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS EXCESSIVE FORCE WAS APPLIED TO THE DEVICE POSSIBLY DUE TO ANATOMICAL OR PROCEDURAL FACTORS WHICH MOST LIKELY CAUSED THE JAW TO BEND AND DEFORM. 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 4 SINGLE USE BIOPSY FORCEPS STANDARD CAPACITY WAS USED DURING A LARGE INTESTINE BIOPSY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE JAWS WERE BENT. REPORTEDLY OTHER BIOPSIES SAMPLES HAD BEEN COLLECTED WITH THIS DEVICE PRIOR TO THE ALLEGED FAILURE, AND THERE WAS NO DIFFICULTY OR RESISTANCE INSERTING OR REMOVING THE DEVICE FROM THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS STANDARD CAPACITY DEVICE. ADDITIONALLY IT WAS REPORTED THAT THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS STANDARD CAPACITY WAS USED DURING A LARGE INTESTINE BIOPSY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE JAWS WERE BENT. REPORTEDLY OTHER BIOPSIES SAMPLES HAD BEEN COLLECTED WITH THIS DEVICE PRIOR TO THE ALLEGED FAILURE, AND THERE WAS NO DIFFICULTY OR RESISTANCE INSERTING OR REMOVING THE DEVICE FROM THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS STANDARD CAPACITY DEVICE. ADDITIONALLY IT WAS REPORTED THAT THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. 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 GOOD.

    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 M00513401 0013788322

    Patients

    Seq Age Sex Outcome Treatment
    1