BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC CO2 REGULATION UNIT

    MDR report key: 6231441 · Received January 6, 2017

    Report

    Report Number
    2951238-2017-00006
    Event Type
    Injury
    Date Received
    January 6, 2017
    Date of Event
    December 8, 2016
    Report Date
    March 18, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    PMA / PMN Number
    PK063786
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND LIMITED INFORMATION WAS PROVIDED. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED; HOWEVER, THE USE OF INCORRECT SIZE OF TUBE SET COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTION MANUAL PROVIDES SEVERAL WARNINGS IN AN ATTEMPT TO PREVENT THIS TYPE OF PATIENT OUTCOME. ¿OVER-INSUFFLATING THE LUMEN MAY CAUSE PATIENT PAIN, INJURY, BLEEDING, GAS EMBOLISM AND/OR PERFORATION. THE OPERATOR OF THE ENDOSCOPIC CO2 REGULATION UNIT MUST BE A PHYSICIAN OR MEDICAL PERSONNEL UNDER THE SUPERVISION OF A PHYSICIAN AND MUST HAVE RECEIVED SUFFICIENT TRAINING IN CLINICAL ENDOSCOPIC TECHNIQUE. THIS MANUAL, THEREFORE, DOES NOT EXPLAIN OR DISCUSS CLINICAL ENDOSCOPIC PROCEDURES. IT ONLY DESCRIBES BASIC OPERATION AND PRECAUTIONS RELATED TO THE OPERATION OF THE ENDOSCOPIC CO2 REGULATION UNIT. CHECK THE GAS TUBE ID ON THE TAG AND CONFIRM THAT THE GAS TUBE MATCHES THE SELECTED FLOW RATE.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM FCX TO HIF.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE USING AN INSUFFLATOR PUMP, THE PATIENT EXPERIENCED BLEEDING DUE TO OVER INSUFFLATION. IT IS NOT KNOWN IF THE PATIENT REQUIRED TREATMENT OR IF THE INTENDED PROCEDURE WAS COMPLETED. IN ADDITION, THE USER FACILITY REPORTED THAT THE INCORRECT TUBE SET SIZE WAS USED DURING THE PROCEDURE. THE USER FACILITY ALSO REPORTED THAT IT IS BELIEVED THAT THE PATIENT¿S OUTCOME WAS DUE TO A USER ERROR BY THE SURGEON AND NOT AN ISSUE WITH THE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12948 ENDOSCOPIC CO2 REGULATION UNIT CO2 REGULATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UCR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other