BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 5113829 · Received March 17, 2004

    Report

    Report Number
    2916714-2004-00009
    Event Type
    Other
    Date Received
    March 17, 2004
    Date of Event
    January 20, 2004
    Report Date
    March 8, 2004
    Manufacturer
    AESCULAP, INC.
    Product Code
    FDF
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION THAT WAS REPORTED ON THE MEDWATCH WAS NOT ENOUGH INFORMATION TO DETERMINE IF THE DEVICE WAS AN AESCULAP PRODUCT. ADDITIONAL INFORMATION REGARDING THE PART NUMBER COULD NOT BE OBTAINED. SINCE A SAMPLE WAS NOT RETURNED FROM THE USER/FACILITY A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. REPORTER STATED "IT WAS A USER ERROR."

    Description of Event or Problem · 1

    PATIENT IN OPERATING ROOM, UNDERGOING BOWEL RESECTION, WHEN IT WAS DISCOVERED THAT THE FILTER ON THE GASTRIC INSTRUMENT PAN WAS NOT PROPERLY SEATED. THE PAN OF INSTRUMENTS WAS REMOVED FROM THE ROOM AND A NEW SET OBTAINED, INCREASING ANESTHESIA TIME. R/O CONTAMINATION. NO INFORMATION ON PART NUMBER WAS AVAILABLE. ITEM NOT BEING RETURNED. SURGERY PROLONGED LESS THAN 30 MIN. REPORTED STATED "IT WAS A USER ERROR." PATIENT IS BEING OBSERVED BY INFECTION CONTROL. AT THIS TIME PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK INSTRUMENT PAN FILTER FDF AESCULAP, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention