BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1882073 · Received October 25, 2010

    Report

    Report Number
    3005099803-2010-04459
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Report Date
    October 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT; NEEDLE BENT. THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE DUE TO THE LACK OF EVIDENCE IDENTIFYING THE USE OF THE DEVICE AND SINCE THERE ARE CONTROLS IN THE MANUFACTURING PROCESS WHICH ASSURE PRODUCT INTEGRITY. (B)(4).

    Additional Manufacturer Narrative · 1

    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)

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINANT, FIVE EVENTS OCCURRED DURING SEPARATE PROCEDURES. THE EVENTS WERE EITHER BENT FORCEPS NEEDLE FOUND DURING INSPECTION PRIOR TO USE, OR NO SMOOTH JAW MOVEMENT ENCOUNTERED DURING THE PROCEDURE. THE EVENT "BENT NEEDLE" IS AN MDR REPORTABLE SCENARIO, AND SINCE IT COULD NOT BE ASCERTAINED WHICH EVENT OCCURRED DURING EACH PROCEDURE, FIVE MANUFACTURER REPORTS HAVE BEEN ESTABLISHED. PLEASE REFERENCE REPORT # 3005099803-2010-04458, 3005099803-2010-04459, 3005099803-2010-04460, 3005099803-2010-04461 AND 3005099803-2010-04462. NO VISIBLE DAMAGE WAS REPORTED TO THE PACKAGING OF THE DEVICE AND THE STERILE BARRIER DID NOT APPEAR COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS DEVICE. 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 FINE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINANT, FIVE EVENTS OCCURRED DURING SEPARATE PROCEDURES. THE EVENTS WERE EITHER BENT FORCEPS NEEDLE FOUND DURING INSPECTION PRIOR TO USE, OR NO SMOOTH JAW MOVEMENT ENCOUNTERED DURING THE PROCEDURE. THE EVENT "BENT NEEDLE" IS AN MDR REPORTABLE SCENARIO, AND SINCE IT COULD NOT BE ASCERTAINED WHICH EVENT OCCURRED DURING EACH PROCEDURE, FIVE MANUFACTURER REPORTS HAVE BEEN ESTABLISHED. PLEASE REFERENCE REPORT # 3005099803-2010-04458, 3005099803-2010-04459, 3005099803-2010-04460, 3005099803-2010-04461 AND 3005099803-2010-04462. NO VISIBLE DAMAGE WAS REPORTED TO THE PACKAGING OF THE DEVICE AND THE STERILE BARRIER DID NOT APPEAR COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS DEVICE. 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 FINE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 0013497921

    Patients

    Seq Age Sex Outcome Treatment
    1