BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIO SURGICAL SYSTEM INDIA

    MDR report key: 10934277 · Received December 2, 2020

    Report

    Report Number
    3010266064-2020-02047
    Event Type
    Injury
    Date Received
    December 2, 2020
    Date of Event
    November 9, 2020
    Report Date
    January 17, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556693506
    PMA / PMN Number
    K191223
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE ANSPACH CONSOLE, PART NUMBER 200419, S/N (B)(6) USED FOR TREATMENT WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS NOT ESTABLISHED. A REVIEW OF MANUFACTURING AND SERVICE RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. NOTHING WAS IDENTIFIED VISUALLY THAT CONTRIBUTED TO THE REPORTED PROBLEM. A FUNCTIONAL EVALUATION WAS PERFORMED. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE DEVICE PERFORMED AS INTENDED AND NO E8 ERROR WAS FOUND. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS FOUND SIMILAR EVENTS. A CAPA, HHE/PRA, FIELD ACTION REVIEW WAS COMPLETED. A REVIEW OF PRIOR ESCALATION ACTIONS FOUND NO ACTIONS APPLICABLE TO THE SCOPE OF THE REPORTED COMPLAINT. REFER TO THE PRODUCT INSTRUCTIONS FOR USE ¿RECOVERY PROCEDURE GUIDELINES¿ TABLE THAT PROVIDES GUIDELINES FOR RECOVERING TO A FULLY MANUAL PROCEDURE IN THE EVENT OF AN UNRECOVERABLE HARDWARE FAILURE. THIS FAILURE IS AN IDENTIFIED FAILURE MODE WITHIN THE RISK ASSESSMENT. THE MEDICAL INVESTIGATION FOUND THAT THE REQUESTED MEDICAL DOCUMENTATION WAS NOT AVAILABLE; HOWEVER, THE SURGEON WAS SATISFIED WITH THE SURGICAL OUTCOME, NO PATIENT INJURY/HARM RESULTED, AND THE PATIENT WAS DISCHARGED/ ¿OK¿. BASED ON THE INFORMATION PROVIDED, NO FURTHER PATIENT IMPACT WOULD BE ANTICIPATED AS PER CORRESPONDENCE, NO PATIENT INJURY/HARM RESULTED FROM THE REPORTED EVENTS. NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. ALTHOUGH THE REPORTED PROBLEM WAS NOT CONFIRMED, A FACTOR THAT MAY HAVE CONTRIBUTED TO THE REPORTED SYMPTOM MAY HAVE BEEN ASSOCIATED WITH A SYSTEM FAULT. ALTHOUGH NO FURTHER CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME, ALL COMPLAINTS ARE MONITORED AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING THE MACHINE SETUP FOR A NAVIO PROCEDURE, THE E8 ERROR POPS ON THE ANSPACH CONSOLE. THE MACHINE WAS RESTARTED AND THE CONNECTIONS OF HANDPIECE RECONNECTED, BUT THE ERROR PERSISTED. THE ISSUE IS WITH THE ANSPACH CONSOLE. THEY CHANGED TO MANUAL PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1396535 NAVIO SURGICAL SYSTEM INDIA ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES 00885556693506

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention CNSL, EMAX 2 PLUS, ANSPACH, ROHS CMPLNT| CNSL, EMAX 2 PLUS, ANSPACH, ROHS CMPLNT