BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1832460 · Received September 13, 2010

    Report

    Report Number
    3005099803-2010-03914
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 18, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE COIL CUT AND THE CLEVIS ARMS BENT. FUNCTIONALLY, THE RETURNED UNIT WAS NOT TESTED DUE TO THE SAMPLE RETURN CONDITION. THE DEVICE WELDING AND RIVETING WAS FOUND TO BE WITHIN SPECIFICATIONS. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS EXCESSIVE FORCE WAS APPLIED TO THE DEVICE DUE TO ANATOMICAL OR PROCEDURAL FACTORS LIMITING THE DEVICE PERFORMANCE. 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. A LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) (DEVICE DAMAGED). 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS STANDARD CAPACITY WAS USED DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FORCEPS WERE NOT BITING THE MUCOSA. REPORTEDLY, THE CUPS WERE BLUNT WHICH LED TO MORE BLEEDING. HOWEVER, NO INTERVENTION WAS REQUIRED TO STOP THE BLEED. ADDITIONAL INFORMATION RECEIVED STATED THAT THE FORCEPS COULD NOT OPEN AND THAT 'THE WING WIRES SEEMED TO HAVE SNAPPED AND LOOKED LIKE THE FORCEPS HAD WINGS.' A DEVICE WAS RECEIVED AND A PRELIMINARY EVALUATION DETERMINED THAT THE CLEVIS ARMS WERE BENT. 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 STANDARD CAPACITY WAS USED DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FORCEPS WERE NOT BITING THE MUCOSA. REPORTEDLY, THE CUPS WERE BLUNT WHICH LED TO MORE BLEEDING. HOWEVER, NO INTERVENTION WAS REQUIRED TO STOP THE BLEED. ADDITIONAL INFORMATION RECEIVED STATED THAT THE FORCEPS COULD NOT OPEN AND THAT 'THE WING WIRES SEEMED TO HAVE SNAPPED AND LOOKED LIKE THE FORCEPS HAD WINGS.' A DEVICE WAS RECEIVED AND A PRELIMINARY EVALUATION DETERMINED THAT THE CLEVIS ARMS WERE BENT. 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 M00513321 0013193075

    Patients

    Seq Age Sex Outcome Treatment
    1