BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1896864 · Received November 11, 2010

    Report

    Report Number
    3005099803-2010-04599
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 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

    THE PATIENT ID, AGE, GENDER AND WEIGHT ARE UNKNOWN. CONCOMITANT MEDICAL PRODUCT - (B)(4) SCOPE ((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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE CLEVIS ARMS WERE BENT. FUNCTIONALLY, THE JAWS OF THE FORCEPS OPENED AND CLOSED WITHIN SPECIFICATION CONSIDERING THE BENT CLEVIS ARMS. THE CONDITION OF THE RETURNED INCIDENT DEVICE CONFIRMS THE REPORTED CONDITION SINCE THE BENT CLEVIS ARMS COULD INTERFERE WITH DEVICE WITHDRAWAL FROM THE SCOPE. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT DUE TO EXCESSIVE FORCE APPLIED TO THE DEVICE BECAUSE OF ANATOMICAL OR PROCEDURAL FACTORS LIMITING THE DEVICE PERFORMANCE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2010-04598 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RADIAL JAW 4 BIOPSY FORCEPS WERE USED DURING A STOMACH BIOPSY PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, WHILE WITHDRAWING THE FORCEPS FROM THE SCOPE, RESISTANCE WAS ENCOUNTERED AND THE CLEVIS WAS FOUND TO BE BENT. A SECOND RADIAL JAW 4 BIOPSY FORCEPS DEVICE WAS USED, HOWEVER, RESISTANCE WAS ENCOUNTERED DURING WITHDRAWAL AND THE CLEVIS WAS FOUND TO BE BENT. THE PROCEDURE WAS COMPLETED WITH A THIRD RADIAL JAW 4 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 GOOD.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2010-04598 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RADIAL JAW 4 BIOPSY FORCEPS WERE USED DURING A STOMACH BIOPSY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, WHILE WITHDRAWING THE FORCEPS FROM THE SCOPE, RESISTANCE WAS ENCOUNTERED AND THE CLEVIS WAS FOUND TO BE BENT. A SECOND RADIAL JAW 4 BIOPSY FORCEPS DEVICE WAS USED, HOWEVER, RESISTANCE WAS ENCOUNTERED DURING WITHDRAWAL AND THE CLEVIS WAS FOUND TO BE BENT. THE PROCEDURE WAS COMPLETED WITH A THIRD RADIAL JAW 4 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 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 M00513381 12922837

    Patients

    Seq Age Sex Outcome Treatment
    1