BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME

    MDR report key: 12083760 · Received June 29, 2021

    Report

    Report Number
    1037905-2021-00284
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    May 25, 2021
    Report Date
    July 23, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    UDI-DI
    10827002319032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EMDR REPORT WAS INITIALLY SENT ON (B)(6) 2021, BASED ON THE INFORMATION THAT "DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME. THE PHYSICIAN VISUALLY IDENTIFIED THAT THE CUTTING WIRE HAD BROKEN JUST ON COMPLETION OF SPHINCTEROTOMY. THE CUTTING WIRE DETACHED AT THE PATIENT END." THE DEVICE WAS RETURNED AND IT WAS NOTED THAT THE CUTTING WIRE BROKE BUT THE ANCHOR REMAINS FULLY INTACT. BASED ON THE ADDITIONAL INFORMATION, THIS INCIDENT NO LONGER MEETS THE REPORTING CRITERIA OF AN FDA MDR REPORT.

    Description of Event or Problem · 0

    THIS CORRECTION FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT SUBMITTED RELATING TO THIS EVENT. REFERENCE THE ADDITIONAL INFORMATION SECTION FOR THIS JUSTIFICATION.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER; OCCUPATION: UNKNOWN. PMA/510(K) # K172288. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME. THE PHYSICIAN VISUALLY IDENTIFIED THAT THE CUTTING WIRE HAD BROKEN JUST ON COMPLETION OF SPHINCTEROTOMY. THE CUTTING WIRE DETACHED AT THE PATIENT END. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978685 FUSION OMNI-TOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY W4441796 10827002319032

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK WIRE GUIDE (B)(6).| ERBE ELECTROSURGICAL GENERATOR.| OLYMPUS 190 SERIES DUODENOSCOPE.