BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTOOL IV

    MDR report key: 10513948 · Received September 10, 2020

    Report

    Report Number
    3009864844-2020-90003
    Event Type
    Injury
    Date Received
    September 10, 2020
    Report Date
    September 3, 2020
    Manufacturer
    MONARCH MEDICAL TECHNOLOGIES
    Product Code
    NDC
    PMA / PMN Number
    K053137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS SUBMITTED IN RESPONSE TO AE REPORT #MW5095572 PUBLISHED ON MAUDE. BASED ON THE LIMITED INFORMATION INCLUDED IN THE ANONYMOUS REPORT AND OUR INTERNAL REVIEW OF ALL CUSTOMER CALL DATA, THE REPORTED EVENT COULD NOT BE CONFIRMED. WITHOUT ADDITIONAL DETAILS ABOUT THE PATIENTS, EVIDENCE ABOUT THE INCIDENTS, INFORMATION ABOUT PRODUCT AT ISSUE, OR CONTACT INFORMATION FOR FOLLOW UP, MONARCH LACKS NECESSARY INFORMATION TO DETERMINE THE ROOT CAUSE OF THE REPORTED PATIENT HARMS.

    Description of Event or Problem · 1

    DURING ROUTINE REVIEW OF THE MAUDE DATABASE, MONARCH BECAME AWARE OF AE REPORT #MW5095572, AN ANONYMOUS REPORT CONTAINING ALLEGATIONS OF SERIOUS HARM (HYPOGLYCEMIA) TO THREE PATIENTS & ONE PATIENT DEATH. HOWEVER, THE REPORT CONTAINED VERY LITTLE DETAIL ABOUT FACTS OR CIRCUMSTANCES LEADING TO THE ALLEGED HARMS/DEATH, WHICH ENDOTOOL PRODUCT(S) IS INVOLVED, HOW THE PRODUCT(S) WAS USED, OR ANY INFORMATION USEFUL IN VERIFYING THE CUSTOMER OR FACTS. THE REPORT SOURCE STATES "I HAVE REPORTED ALL THREE PATIENTS TO OUR QUALITY ASSURANCE TEAM. I SPOKE WITH THE CLINICAL TEAM OF THE PHARMACY AND SPOKE WITH THE HEAD OF THE ICU. SADLY THERE HAVE BEEN NO CHANGES THAT WOULD PREVENT ANOTHER PATIENT FROM BEING HARMED." ALTHOUGH USER FACILITIES ARE REQUIRED BY LAW TO REPORT DEVICE-RELATED SERIOUS INJURIES AND DEATHS TO THE MANUFACTURER, MONARCH'S INTERNAL INVESTIGATION DID NOT DISCOVER ANY REPORTS OF PATIENT HARM OR DEATH THAT CORRESPONDS WITH THIS REPORT. USING THE LIMITED INFORMATION AVAILABLE IN THE REPORT, MONARCH QUERIED ALL CUSTOMER CALL RECORDS TO FIND ALL RECORDS THAT COULD BE RELATED TO THIS ADVERSE EVENT, CONDUCTED A THOROUGH REVIEW OF ANY POTENTIALLY RELATED CASES AND CONTACTED CUSTOMERS FOR ADDITIONAL INFORMATION, AS NEEDED; HOWEVER, NO EVIDENCE OF MALFUNCTION RESULTING IN PATIENT HARMS/DEATH WAS DISCOVERED. WITHOUT FURTHER INFORMATION ABOUT THE CIRCUMSTANCES LEADING TO THE ALLEGED HARMS/DEATH OR THE EVENTS THEMSELVES WE CANNOT CONCLUDE THAT ANY ENDOTOOL SOFTWARE CAUSED OR CONTRIBUTED TO THE REPORTED ADVERSE EVENTS. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981594 ENDOTOOL IV ENDOTOOL IV NDC MONARCH MEDICAL TECHNOLOGIES IV X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other