BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1981920 · Received February 8, 2011

    Report

    Report Number
    3005099803-2011-00271
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE NEEDLE BENT. NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING AND WELDING WHICH WERE WITHIN SPECIFICATIONS. FUNCTIONALLY THE DEVICE JAWS WOULD OPEN HOWEVER, THE BENT NEEDLE DID NOT ALLOW PROPER JAW CLOSURE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT; JAWS WON'T CLOSE. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS EXCESSIVE FORCE WAS APPLIED TO THE DEVICE DUE TO ANATOMICAL OR PROCEDURAL FACTORS, WHICH MOST LIKELY CAUSED THE NEEDLE TO BEND AND INTERFERE WITH JAW CLOSURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4):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

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-00271, 3005099803-2011-00272, 3005099803-2011-00273 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, EACH OF THE THREE DEVICES WAS INSERTED INTO THE PATIENT WHEN IT WAS NOTICED THAT THE FORCEPS WOULD NOT CLOSE ONTO THE SPECIMEN. UPON REMOVING EACH DEVICE FROM THE PATIENT, THE NEEDLE WAS FOUND TO BE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS DEVICE. REPORTEDLY EACH DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. ADDITIONALLY, IT WAS REPORTED THAT NO RESISTANCE WAS ENCOUNTERED WHILE INSERTING THE DEVICE INTO THE SCOPE. THERE WAS NO BLEEDING AND 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

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-00271, 3005099803-2011-00272, 3005099803-2011-00273 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, EACH OF THE THREE DEVICES WAS INSERTED INTO THE PATIENT WHEN IT WAS NOTICED THAT THE FORCEPS WOULD NOT CLOSE ONTO THE SPECIMEN. UPON REMOVING EACH DEVICE FROM THE PATIENT, THE NEEDLE WAS FOUND TO BE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS DEVICE. REPORTEDLY EACH DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. ADDITIONALLY, IT WAS REPORTED THAT NO RESISTANCE WAS ENCOUNTERED WHILE INSERTING THE DEVICE INTO THE SCOPE. THERE WAS NO BLEEDING AND 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 M00515373 0013878347

    Patients

    Seq Age Sex Outcome Treatment
    1