BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1840434 · Received September 21, 2010

    Report

    Report Number
    3005099803-2010-03982
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Report Date
    August 31, 2010
    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

    PATIENT IDENTIFIER, PATIENT AGE, DATE OF BIRTH, GENDER AND WEIGHT ARE UNKNOWN. PATIENT IS OVER 18 YEARS OLD. THE DATE OF EVENT IS UNKNOWN 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 THE CATHETER CUT AND THE CLEVIS ARMS BENT. THE DEVICE COULD NOT BE FUNCTIONALLY TESTED DUE TO THE PRESENT CONDITION. THOUGH THERE WAS NO DAMAGE NOTED TO THE JAWS, THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT, DUE TO DAMAGE PRESENT TO THE CLEVIS ARMS. ADDITIONALLY, THE BENT CLEVIS ARMS COULD INTERFERE WITH DEVICE WITHDRAWAL FROM THE SCOPE. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT SINCE EXCESSIVE FORCE WAS APPLIED TO THE DEVICE DUE OF ANATOMICAL OR PROCEDURAL FACTORS LIMITING THE DEVICE PERFORMANCE. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 SINGLE-USE BIOPSY FORCEPS WAS USED DURING A BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, AFTER TAKING A BIOPSY SPECIMEN DEVICE COULD NOT BE RETRACTED THROUGH THE ENDOSCOPE. THE FORCEPS, ALONG WITH THE SCOPE, WERE REMOVED FROM THE PATIENT. THE DISTAL PART OF THE FORCEPS HAD TO BE CUT FOR REMOVAL FROM THE SCOPE. UPON REMOVAL OF THE DEVICE DAMAGE WAS NOTED TO THE JAWS. THE SCOPE WAS RE-INSERTED AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 SINGLE-USE BIOPSY FORCEPS WAS USED DURING A BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, AFTER TAKING A BIOPSY SPECIMEN DEVICE COULD NOT BE RETRACTED THROUGH THE ENDOSCOPE. THE FORCEPS, ALONG WITH THE SCOPE, WERE REMOVED FROM THE PATIENT. THE DISTAL PART OF THE FORCEPS HAD TO BE CUT FOR REMOVAL FROM THE SCOPE. UPON REMOVAL OF THE DEVICE DAMAGE WAS NOTED TO THE JAWS. THE SCOPE WAS RE-INSERTED AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 M00513382 0013412490

    Patients

    Seq Age Sex Outcome Treatment
    1