BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISOR BRONCHO DISPOSABLE BIOPSY FORCEPS

    MDR report key: 883825 · Received June 20, 2007

    Report

    Report Number
    1223688-2007-00007
    Event Type
    Death
    Date Received
    June 20, 2007
    Date of Event
    May 1, 2007
    Manufacturer
    CONMED ENDOSCOPIC TECHNOLOGIES
    Product Code
    FCL
    PMA / PMN Number
    K922086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION. DHR REVIEW WAS NOT POSSIBLE WITHOUT A VALID LOT NUMBER. A SEARCH OF THE DATABASE WAS PERFORMED FROM 2005 TO PRESENT. NO OTHER COMPLAINTS WERE FOUND FOR THE REPORTED CONDITION. THE COMPLAINT DATABASE WILL BE MONITORED FOR FURTHER OCCURRENCES.

    Description of Event or Problem · 1

    USER FACILITY WAS PERFORMING A BRONCHOSCOPY WITH FLUORO ON AN ILL PATIENT USING THE PRECISOR BRONCHO FORCEPS. USER ALLEGES WHILE GRABBING TISSUE FROM THE RIGHT LOWER LOBE OF THE LUNG THAT HE TOOK SURROUNDING TISSUE WITH IT CAUSING THE SITE TO BLEED EXCESSIVELY. THE PATIENT DIED AFTER THE PROCEDURE (CAUSE OF DEATH WAS NOT DUE TO EXCESSIVE BLEEDING PER USER FACILITY). AFTER THE FACILITY'S 10 DAY PERIOD AND DURING THE CASE REVIEW, THE PHYSICIAN ALLEGES THAT THE LENGTH OF THE FORCEP IS TOO AGRESSIVE. (NO SAMPLE WILL BE RETURNED AND THE LOT NUMBER IS UNKNOWN. THE DEVICE WAS DISCARDED BY FACILITY AS THEY DID NOT EXPECT THE PATIENT TO EXPIRE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISOR BRONCHO DISPOSABLE BIOPSY FORCEPS BIOPSY FORCEPS FCL CONMED ENDOSCOPIC TECHNOLOGIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death