BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE LIGATING DEVICE

    MDR report key: 6543011 · Received May 3, 2017

    Report

    Report Number
    2951238-2017-00294
    Event Type
    Malfunction
    Date Received
    May 3, 2017
    Date of Event
    March 21, 2017
    Report Date
    March 8, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FHN
    PMA / PMN Number
    PK980465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE USER FACILITY. ADDITIONAL INFORMATION RECEIVED FROM THE USER FACILITY STATES THAT THE SCOPE WAS WITHDRAWN AND PATIENT WAS REMOVED FROM THE PROCEDURE ROOM WITH THE POLY LOOP REMAINING INTACT, WHILE AN ENDO SCISSOR WAS OBTAINED FROM A DIFFERENT FACILITY. UPON RETRIEVING THE ENDO SCISSORS THE PATIENT WAS SEDATED AGAIN AND BROUGHT BACK TO THE PROCEDURE ROOM TO HAVE THE POLYLOOP WIRE REMOVED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM FDT TO FHN.

    Additional Manufacturer Narrative · 1

    NO DEVICE RETURNED TO OLYMPUS FOR EVALUATION. HOWEVER, BASED ON SIMILAR REPORT THIS TYPE ISSUE OCCURS WHEN THE LOOP IS CAUGHT BETWEEN THE HOOP AND THE COIL SHEATH. THE DEVICE INSTRUCTION MANUAL WARNS USERS "WHEN REMOVING THE HOOK FROM THE LOOP, CONFIRM ON THE ENDOSCOPIC IMAGE THAT THE COIL SHEATH IS EXTENDED FROM THE TUBE SHEATH. OTHERWISE, THE LOOP MAY GET STUCK INSIDE THE CHANNEL."

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE POLY LOOP BECAME STUCK AROUND A POLYP AND WILL NOT RELEASE. THE CUSTOMER DID NOT HAVE THE CORRECT CUTTERS TO CUT THIS LOOP OFF. CUSTOMER WILL HAVE TO GAIN ACCESS TO THE CORRECT CUTTERS TO REMOVE THIS LOOP. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321766 SINGLE USE LIGATING DEVICE SINGLE USE LIGATING DEVICE FHN OLYMPUS MEDICAL SYSTEMS CORP. HX-400U-30 V6426

    Patients

    Seq Age Sex Outcome Treatment
    1 Other