BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION PRE-LOADED OMNI-TOME

    MDR report key: 2172239 · Received June 24, 2011

    Report

    Report Number
    1037905-2011-00440
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNS
    PMA / PMN Number
    K052051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: OUR LAB EVAL OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT OF INCORRECT CUTTING WIRE ORIENTATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE CONDITION OF THE PRODUCT SAID TO BE INVOLVED PROHIBITED A COMPLETE EVALUATION. A FUNCTIONAL TEST WAS NOT CONDUCTED BECAUSE THE CUTTING WIRE WAS BROKEN. NO SECTION OF THE CUTTING WIRE WAS MISSING. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LAB ANALYSIS OF THE RETURNED PRODUCT. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. A SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN INVENTORY. CONCLUSIONS: A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE CONDITION OF THE PRODUCT SAID TO BE INVOLVED PROHIBITED A COMPLETE EVALUATION. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. PRIOR TO DISTRIBUTION, ALL FUSION OMNI-TOME SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION PRE-LOADED OMNI-TOME. THE USER EXPERIENCED DIFFICULTY CANNULATING THE DUCT DUE TO INCORRECT CUTTING WIRE ORIENTATION. THE CUTTING WIRE REPORTEDLY EXITED THE ENDOSCOPE FACING IN A 3-4 O'CLOCK POSITION. THE SPHINCTEROTOME WAS REMOVED FROM THE ENDOSCOPE AND A BALLOON WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION PRE-LOADED OMNI-TOME KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES KNS WILSON-COOK MEDICAL INC. W2984916

    Patients

    Seq Age Sex Outcome Treatment
    1 ERBE ELECTROSURGICAL UNIT| ACTIVE CORD (UNKNOWN TYPE)| OLYMPUS ERCP ENDOSCOPE