BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1821120 · Received August 31, 2010

    Report

    Report Number
    3005099803-2010-03706
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 OPERATIONAL CONTEXT AS EXCESSIVE FORCE WAS APPLIED TO THE DEVICE DUE TO ANATOMICAL OR PROCEDURAL FACTORS IN WHICH THE DEVICE NEEDLE WAS BENT. 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

    PATIENT IDENTIFIER, AGE AND WEIGHT ARE UNKNOWN, HOWEVER, PATIENT OVER 18 YEARS OLD. 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 USED DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND AFTER SEVERAL BIOPSY SAMPLES, THE NEEDLE WAS BENT AND STUCK OUT FROM THE SIDE OF THE JAWS. THE PROCEDURE WAS COMPLETED WITH THIS 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS WAS USED DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND AFTER SEVERAL BIOPSY SAMPLES, THE NEEDLE WAS BENT AND STUCK OUT FROM THE SIDE OF THE JAWS. THE PROCEDURE WAS COMPLETED WITH THIS 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 3 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00515350 13244546

    Patients

    Seq Age Sex Outcome Treatment
    1