BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1896975 · Received November 11, 2010

    Report

    Report Number
    3005099803-2010-04762
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Report Date
    October 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE NEEDLE WAS TILTED DUE TO NEEDLE TAIL WAS BENT OUT OF THE CLEVIS. ADDITIONALLY, NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING AND WELDING WHICH WERE WITHIN DESIGN SPECIFICATIONS. FUNCTIONALLY THE DEVICE JAWS WOULD OPEN PROPERLY, HOWEVER THEY DID NOT HAVE PROPER JAW CLOSURE. ADDITIONALLY THE DEVICE FAILED THE DIMENSIONAL INSPECTION DUE TO THE BENT NEEDLE TAIL. THE PULL WIRE CURVES WERE REVIEWED AND FOUND TO BE WITHIN SPECIFICATION. THOUGH THE NEEDLE WAS NOT BENT, THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT, DUE TO THE NEEDLE BEING TILTED. ADDITIONALLY, BECAUSE THE NEEDLE TAIL WAS BENT OUT OF THE CLEVIS, THIS MAY HAVE BEEN INTERPRETED AS NEEDLE BENT BY THE CUSTOMER. THE MOST PROBABLE CAUSE IS HANDLING DAMAGE AS THE UNIT WAS HANDLED AND THE DAMAGE MAY HAVE OCCURRED DURING UNPACKING, PREPARATION OR TESTING. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT (B)(4).

    Additional Manufacturer Narrative · 1

    THE PATIENT ID, AGE, GENDER AND WEIGHT ARE UNKNOWN. THE EVENT DATE IS UNKNOWN. (B)(4) IS RELATED TO (B)(4) FOR THE REPORTED EVENT OF NEEDLE BENT. 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-04763 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RADIAL JAW 4 BIOPSY FORCEPS WERE USED DURING A BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, AFTER REMOVAL OF THE DEVICE FROM THE PACKAGING, THE NEEDLE WITHIN THE FORCEPS JAWS WAS FOUND TO BE BENT. A SECOND RADIAL JAW 4 BIOPSY FORCEPS WAS OPENED, BUT EXHIBITED THE SAME NEEDLE BENT CONDITION. NO VISIBLE DAMAGE WAS NOTED TO THE DEVICE PACKAGING AND THE STERILE BARRIER DID NOT APPEAR COMPROMISED. THE PROCEDURE WAS SUCCESSFULLY 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 FINE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-04763 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RADIAL JAW 4 BIOPSY FORCEPS WERE USED DURING A BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, AFTER REMOVAL OF THE DEVICE FROM THE PACKAGING, THE NEEDLE WITHIN THE FORCEPS JAWS WAS FOUND TO BE BENT. A SECOND RADIAL JAW 4 BIOPSY FORCEPS WAS OPENED, BUT EXHIBITED THE SAME NEEDLE BENT CONDITION. NO VISIBLE DAMAGE WAS NOTED TO THE DEVICE PACKAGING AND THE STERILE BARRIER DID NOT APPEAR COMPROMISED. THE PROCEDURE WAS SUCCESSFULLY 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 FINE.

    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 M00513332 0013685079

    Patients

    Seq Age Sex Outcome Treatment
    1