BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 2011033 · Received March 8, 2011

    Report

    Report Number
    3005099803-2011-00680
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 16, 2011
    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

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE EYELET NOT CORRECTLY RIVETED AND THE DISTAL ASSEMBLY LOOSE. IN ADDITION, THE CLEVIS ARMS WERE BENT DUE TO THE LOOSE EYELET. FUNCTIONALLY, THE RETURNED UNIT WAS NOT TESTED DUE TO THE SAMPLE RETURN CONDITION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT SINCE THE RETURNED DEVICE VISUALLY REFLECTS THE REPORTED ISSUE. THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING DUE TO THE IMPROPER DEVICE RIVETING OF THE EYELET COMPONENT. CORRECTIONS HAVE BEEN IMPLEMENTED TO ADDRESS THE ISSUE. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS UNKNOWN; HOWEVER REPORTED TO BE OVER (B)(6). 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 COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE WITHDRAWING THE DEVICE THROUGH THE SCOPE BUT WAS ABLE TO WITHDRAW IT COMPLETELY. ONCE OUTSIDE THE PATIENT THE DEVICE WAS INSPECTED AND IT WAS NOTICED THAT THE CUPS WERE DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS STANDARD CAPACITY DEVICE. IT COULD NOT BE REPORTED IF THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE. REPORTEDLY THERE WAS NO DIFFICULTY OR RESISTANCE INSERTING THE DEVICE INTO THE SCOPE. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS STANDARD CAPACITY WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE WITHDRAWING THE DEVICE THROUGH THE SCOPE BUT WAS ABLE TO WITHDRAW IT COMPLETELY. ONCE OUTSIDE THE PATIENT THE DEVICE WAS INSPECTED AND IT WAS NOTICED THAT THE CUPS WERE DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS STANDARD CAPACITY DEVICE. IT COULD NOT BE REPORTED IF THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE. REPORTEDLY THERE WAS NO DIFFICULTY OR RESISTANCE INSERTING THE DEVICE INTO THE SCOPE. 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 M00513411 0013664339

    Patients

    Seq Age Sex Outcome Treatment
    1