BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1896978 · Received November 11, 2010

    Report

    Report Number
    3005099803-2010-04763
    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

    THE PATIENT ID, AGE, GENDER AND WEIGHT ARE UNKNOWN. THE EVENT DATE IS UNKNOWN. 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 NEEDLE BENT. NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING AND WELDING WHICH WERE WITHIN SPECIFICATIONS. FUNCTIONALLY THE DEVICE JAWS WOULD OPEN HOWEVER, THE BENT NEEDLE DID NOT ALLOW PROPER JAW CLOSURE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT; NEEDLE BENT. 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).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-04762 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 # 3005099803-2010-04762 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 0013540502

    Patients

    Seq Age Sex Outcome Treatment
    1