BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 8795406 · Received July 16, 2019

    Report

    Report Number
    3005985723-2019-00515
    Event Type
    Malfunction
    Date Received
    July 16, 2019
    Date of Event
    July 3, 2019
    Report Date
    November 27, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MPS REPORTED HYBRID CABLE LOOSE AND DIFFICULTY GETTING FISSO ARM TO TIGHTEN. DEVICE EVALUATION AND RESULTS: PER (B)(4): FSE REPLACED PART NUMBER 201130 ARTIC ARMS;5800-50 STERI, 560MM, M10/M12. SYSTEM WAS FOUND TO BE WITHIN MAKO TOLERANCES AND SPECIFICATIONS. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 04/06/2010 1 DEVICE WAS INSPECTED AND NO DATA DEVICE WAS PLACED ON: NPR 09-11-0078, NPR 10-03-0012, NPR 10-03-0032, NPR 10-02-0126, NPR 10-02-0125, NPR 10-02-0097, DEV 10-03-0010, DEV 10-03-0046, NPR 10-03-0157, NPR 10-04-0011, NPR 10-03-0146, NPR 10-03-0056, NPR 10-03-0061, NPR 10-03-0016, NPR 10-03-0057. A REVIEW OF THE DATA REVEALED THAT THE NON-CONFORMANCES ARE NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW : A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 201130 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: SYSTEM READY FOR CLINICAL USE.

    Description of Event or Problem · 0

    CASE NUMBER: (B)(4), MPS (B)(6) REPORTED HYBRID CABLE LOOSE AND DIFFICULTY GETTING FISSO ARM TO TIGHTEN. UPDATE: "PROBLEM NOTICED- LOOSE CABLES WERE NOTICED INTRA-OP PRIOR TO MAKING CUTS WHEN THERE WAS A SOFTWARE ERROR THAT CAME UP. CASE TYPE: PKA. SURGICAL DELAY- 20 MINUTES. UPDATE: WAS THE PATIENT UNDER ANESTHESIA? AS PER MPS: "YES THE PATIENT WAS UNDER ANESTHESIA". CASE CANCELLED- NO. CASE COMPLETED SUCCESSFULLY - YES. CASE COMPLETED MANUALLY- NO, I WAS ABLE TO RE-TIGHTEN. CABLES AS WELL AS TROUBLESHOOT THE SOFTWARE ISSUE THAT THE SYSTEM WAS GIVING ME. WE WERE ABLE TO COMPLETE THE CASE ROBOTICALLY. INVESTIGATION RESULTS- YES"

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    CASE NUMBER: (B)(4), MPS (B)(6) REPORTED HYBRID CABLE LOOSE AND DIFFICULTY GETTING FISSO ARM TO TIGHTEN. UPDATE: "PROBLEM NOTICED: LOOSE CABLES WERE NOTICED INTRA-OP PRIOR TO MAKING CUTS WHEN THERE WAS A SOFTWARE ERROR THAT CAME UP. CASE TYPE: PKA. SURGICAL DELAY: 20 MINUTES. UPDATE: WAS THE PATIENT UNDER ANESTHESIA? AS PER MPS: "YES THE PATIENT WAS UNDER ANESTHESIA". CASE CANCELLED: NO. CASE COMPLETED SUCCESSFULLY: YES. CASE COMPLETED MANUALLY: NO, I WAS ABLE TO RE-TIGHTEN CABLES AS WELL AS TROUBLESHOOT THE SOFTWARE ISSUE THAT THE SYSTEM WAS GIVING ME. WE WERE ABLE TO COMPLETE THE CASE ROBOTICALLY. INVESTIGATION RESULTS: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589821 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization