BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME SPHINCTEROTOME

    MDR report key: 1791239 · Received August 6, 2010

    Report

    Report Number
    1037905-2010-00354
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Report Date
    July 9, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    PMA / PMN Number
    K052051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: WE COULD NOT CONFIRM THE REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVAL. WE COULD NOT CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD OR CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE LOT NUMBER COULD NOT BE DETERMINED. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS REMOTE. 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. THE FUNCTIONAL TEST INCLUDES BOWING THE SPHINCTEROTOME TO ENSURE THE DISTAL END RESPONDS TO HANDLE MANIPULATION. CORRECTIVE ACTION: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THIS REPORT COULD NOT BE VERIFIED. THE COMPLAINT RISK PRIORITY NUMBER (CRPN) FOR THIS TYPE OF OCCURRENCE HAS BEEN CALCULATED BASED ON THE RATE OF OCCURRENCE AND SEVERITY OF THE OUTCOME. BASED ON THIS ACTIVITY, NO FURTHER ACTION IS WARRANTED AT THE TIME. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK ENDOSCOPY FUSION OMNI-TOME SPHINCTEROTOME. THE PHYSICIAN INDICATED THE RADIOPAQUE BAND REMAINED IN THE PT AFTER USE OF THE SPHINCTEROTOME. THE BAND WAS LEFT TO PASS NATURALLY THROUGH THE GASTROINTESTINAL TRACT. THE PT DID NOT REQUIRE ANY ADD'L MEDICAL PROCEDURES DUE TO THIS OCCURRENCE. 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 SPHINCTEROTOME KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES KNS COOK ENDOSCOPY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ERBE ELECTROSURGICAL GENERATOR| ENDOSCOPE (UNK TYPE)