BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 2011528 · Received March 9, 2011

    Report

    Report Number
    3005099803-2011-00679
    Event Type
    Malfunction
    Date Received
    March 9, 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 THAT ONE OF THE PULL WIRES WAS BROKEN. ADDITIONALLY TISSUE SPECIMEN WAS NOTICED WITHIN ONE OF THE BIOPSY FORCEPS CUPS. FUNCTIONALLY, THE RETURNED UNIT WAS NOT TESTED DUE TO THE SAMPLE RETURN CONDITION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE JAWS WERE BENT. DURING DEVICE ANALYSIS IT WAS FOUND THAT ONE OF THE PULL WIRES WAS BROKEN, WHICH COULD HAVE CAUSED THE REPORTED THE CUP "SWINGING". SINCE THERE ARE CONTROLS IN THE MANUFACTURING PROCESS THAT VERIFY PRODUCT INTEGRITY, THE SPECIFIC CAUSE OF THE FAILURE CANNOT BE IDENTIFIED. THEREFORE THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE DUE TO THE LACK OF EVIDENCE IDENTIFYING THE USE OF THE DEVICE 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 (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 3 SINGLE-USE BIOPSY FORCEPS WAS TO BE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, FOR THE PROCEDURE, THE PHYSICIAN FOUND THAT THE PROXIMAL END OF THE CUP HAD A BEND, AND ATTEMPTED TO OPEN THE CUP, THE CUP WAS "SWINGING". 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS WAS TO BE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, FOR THE PROCEDURE, THE PHYSICIAN FOUND THAT THE PROXIMAL END OF THE CUP HAD A BEND, AND ATTEMPTED TO OPEN THE CUP, THE CUP WAS "SWINGING". 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 GOOD.

    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 M00515362 0013772705

    Patients

    Seq Age Sex Outcome Treatment
    1