BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE LIGATING DEVICE

    MDR report key: 7270617 · Received February 14, 2018

    Report

    Report Number
    2951238-2018-00115
    Event Type
    Injury
    Date Received
    February 14, 2018
    Date of Event
    January 29, 2018
    Report Date
    March 8, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FHN
    PMA / PMN Number
    PK980465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION, SO THE CAUSE OF THE REPORTED COMPLAINT CANNOT BE CONFIRMED. DESPITE MULTIPLE FOLLOWUP ATTEMPTS, NO FURTHER DETAIL WAS AVAILABLE REGARDING HOW THE DEVICE BECAME STUCK OR WHAT PATIENT INJURY RESULTED. AS MITIGATION FOR A STUCK DEVICE, THE INSTRUCTION MANUAL CONTAINS EMERGENCY TREATMENT DIRECTIONS FOR REMOVING THE DEVICE: ¿ALWAYS HAVE THE OLYMPUS LOOP CUTTER (FS-5L/Q/U-1), PLIERS AND/OR WIRE CUTTERS READY TO CUT THE COIL SHEATH, TUBE SHEATH AND OPERATION WIRE IN CASE THE LOOP CANNOT BE DETACHED FROM THE INSTRUMENT.¿ AS PREVENTIVE MEASURES, THE INSTRUCTION MANUAL ALSO STATES, ¿ALWAYS HAVE A SPARE INSTRUMENT AVAILABLE¿ AND ¿USE THIS INSTRUMENT IN AN ENVIRONMENT EQUIPPED TO ACCOMMODATE OPEN SURGERY AND HAVE THE HOSPITALIZATION PLAN PREPARED IN CASE ANY PROBLEM OCCURS THAT MAY NOT BE RESOLVED ENDOSCOPICALLY.¿ THE INSTRUCTION MANUAL ALSO WARNS THAT THE LOOP MAY NOT DETACH IF USED WITH AN INCOMPATIBLE ENDOSCOPE, OR IF THE LOOP IS DEPLOYED TOO NEAR THE DISTAL END OF THE DEVICE TO AVOID TANGLING WITH THE HOOK. THE INSTRUCTION MANUAL ALSO CONTAINS STEPS FOR PRE-PROCEDURE VISUAL AND TACTILE INSPECTION OF THE DEVICE.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNKNOWN PROCEDURE, THE POLYLOOP DEVICE BECAME STUCK IN THE PATIENT AND WOULD NOT RELEASE. THE EMERGENCY TREATMENT STEPS PER THE INSTRUCTION MANUAL WERE USED TO REMOVE THE PROXIMAL PART OF THE DEVICE AND THE ENDOSCOPE. THE PATIENT HAD ADDITIONAL SURGICAL INTERVENTION TO REMOVE THE REMAINING COIL SHEATH OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113387 SINGLE USE LIGATING DEVICE SINGLE USE LIGATING DEVICE FHN OLYMPUS MEDICAL SYSTEMS CORP. HX-400U-30 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN MODEL ENDOSCOPE