BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE LIGATING DEVICE

    MDR report key: 7148475 · Received December 27, 2017

    Report

    Report Number
    2951238-2017-00788
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Date of Event
    December 5, 2017
    Report Date
    March 8, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    PMA / PMN Number
    PK980465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION BASED ON NEW DETAIL FROM THE USER FACILITY REGARDING THE EVENT. A POTENTIAL CAUSE FOR THE DAMAGE TO THE SPRING AND RESULTING STUCK DEVICE IS OPERATOR TECHNIQUE. THE INSTRUCTION MANUAL WARNS, ¿DO NOT APPLY UNNECESSARY FORCE TO THE LOOP WHEN LIGATING TISSUE DURING THE PROCEDURE. EXCESSIVE FORCE APPLIED TO THE LOOP COULD CUT THE SURROUNDING BODY CAVITY TISSUE, RESULTING IN PATIENT INJURY¿. IT MAY ALSO DAMAGE THE ENDOSCOPE AND/OR INSTRUMENT.¿ ¿DO NOT PULL THE SLIDER BEFORE SURROUNDING THE TARGET TISSUE WITH THE LOOP. OTHERWISE, THE LOOP STOPPER WOULD BE DISLODGED.¿ AND ¿WHEN OPERATING THE TUBE JOINT, BE CAREFUL NOT TO MOVE THE SLIDER.¿ 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 STATES THAT PRIOR TO USE IN A PROCEDURE, THE DEVICE SHOULD BE INSPECTED FOR DAMAGE TO THE COIL SHEATH, WHICH MAY MAKE THE LOOP IMPOSSIBLE TO DETACH, AND FOR DAMAGE TO THE HANDLE.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION, SO THE CAUSE OF THE REPORTED COMPLAINT CANNOT BE CONFIRMED. 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.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT AT THE BEGINNING OF A COLONOSCOPY, THE POLYLOOP DEVICE BECAME STUCK IN THE PATIENT. THE NURSE OPERATING THE DEVICE HAD TECHNIQUE DIFFICULTIES IN RELEASING THE LOOP. AFTER SEVERAL TRIES INVOLVING PUSHING AND PULLING ON THE HANDLE, THE SPRING BROKE FROM THE HANDLE. THE DEVICE THEN COULD NOT BE OPERATED. THERE WAS A DELAY IN THE PROCEDURE WHILE THE USER FACILITY LOCATED THE COMPATIBLE LOOP CUTTER TO FREE THE DEVICE PER THE INSTRUCTION MANUAL. AFTER THE LOOP CUTTER WAS LOCATED AND USED, THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WAS NO REPORTED INJURY OR DEVICE FRAGMENTATION INTO THE PATIENT.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A COLONOSCOPY, THE POLYLOOP DEVICE BECAME STUCK IN THE PATIENT. THERE WAS A DELAY IN THE PROCEDURE WHILE THE USER FACILITY LOCATED THE COMPATIBLE LOOP CUTTER TO FREE THE DEVICE PER THE INSTRUCTION MANUAL. AFTER THE LOOP CUTTER WAS LOCATED AND USED, THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WAS NO REPORTED INJURY OR DEVICE FRAGMENTATION INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927203 SINGLE USE LIGATING DEVICE SINGLE USE LIGATING DEVICE FDT OLYMPUS MEDICAL SYSTEMS CORP. HX-400U-30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1