BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME

    MDR report key: 2112724 · Received May 27, 2011

    Report

    Report Number
    1037905-2011-00351
    Event Type
    Malfunction
    Date Received
    May 27, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    PMA / PMN Number
    K052051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THIS REPORT WAS PROVIDED TO US BY THE COOK FACILITY IN (B)(6) ON BEHALF OF A DISTRIBUTOR IN (B)(6). (B)(4). EVAL: A PRODUCT EVAL WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVAL. THE REPORT COULD NOT BE CONFIRMED. 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. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. (B)(4). CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. 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: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THIS REPORT COULD NOT BE VERIFIED. HOWEVER, THIS TYPE OF OCCURRENCE HAS BEEN BROUGHT TO THE ATTENTION OF THE APPROPRIATE INTERNAL PERSONNEL IN AN EFFORT TO HEIGHTEN AWARENESS. NO FURTHER ACTION WAS TAKEN AT THIS TIME. CUSTOMER QA WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME. THE SPHINCTEROTOME WAS INTRODUCED INTO THE ACCESSORY CHANNEL OF THE ENDOSCOPE. WHEN THE SPHINCTEROTOME EXITED THE ENDOSCOPE, THE CUTTING WIRE ORIENTATION WAS INCORRECT. 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 OMNI-TOME KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES KNS WILSON-COOK MEDICAL INC W2950544

    Patients

    Seq Age Sex Outcome Treatment
    1 ELECTROSURGICAL UNIT (UNK TYPE)| ENDOSCOPE (UNK TYPE)| ACTIVE CORD (UNK TYPE)