BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSEMBLY-ROTARY SCALE: 190-00126

    MDR report key: 8209258 · Received January 2, 2019

    Report

    Report Number
    3005985723-2019-00008
    Event Type
    Malfunction
    Date Received
    January 2, 2019
    Date of Event
    December 17, 2018
    Report Date
    March 26, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: MPS (B)(6) REPORTED SYSTEM HAS HAD MULTIPLE JOINT ANGLES INCONSISTENT ERRORS TKA SURGICAL. DEVICE EVALUATION AND RESULTS: PER (B)(4): DURING INVESTIGATION, SYSTEM UTILITIES SHOWED THAT J6 WAS THE JOINT THAT WAS HAVING ARM INCONSISTENCY ERRORS IN THE SYSTEM LOGS. REMOVED J6 PROTECTIVE COVER OF J6 GLASS ENCODER AND FOUND BLOOD/TISSUE ON THE ENCODER CAUSING ENCODER COUNTS TO STOP ON THE JOINT AND THEN THE SYSTEM ERROR: JOINT INCONSISTENCY ERROR WOULD OCCUR AND LOCK THE ARM. THOROUGHLY CLEANED THE J6 GLASS ENCODER. CHECKED J6 ENCODER READ HEAD WITH SMART PRECISION SOFTWARE TOOL, CHECKED GOOD. ALL SYSTEM CHECKS AND TESTS PASSED, SYSTEM IS READY FOR PATIENT USE. PRODUCT HISTORY REVIEW : A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 03/23/10 1 DEVICE WAS INSPECTED AND 1 DEVICE WAS PLACED ON: NPR 10-02-0098, NPR 10-03-0060, NPR 10-03-0091, NPR 10-03-0102, NPR 10-01-0133, NPR 10-03-0101, NPR 10-03-0021, NPR 09-10-0003, NPR 10-02-0097, NPR 10-02-0125, NPR 10-01-0121, NPR 10-02-0043, NPR 10-02-0076. 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 201903 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE REPORTED EVENT WAS CONFIRMED, SYSTEM READY FOR CLINICAL USE. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. PER D03391, PREVENTIVE MAINTENANCE IS WHERE AN ACTION OCCURS THAT IDENTIFIES DEVICE DETERIORATION WHICH MAY COMPROMISE FUNCTION. UNDER PM CONDITIONS NO PATIENT WAS INVOLVED AND NO ACTUAL OR POTENTIAL PATIENT HARM EXISTED FOR THE ALLEGED EVENT. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    Description of Event or Problem · 0

    (B)(4): MPS (B)(6) REPORTED SYSTEM HAS HAD MULTIPLE JOINT ANGLES INCONSISTENT ERRORS TKA SURGICAL DELAY <30 MIN PATIENT WAS UNDER ANESTHESIA AT THE TIME OF THE ISSUE AFTER MANY TIMES TRYING TO REGISTER THE ROBOT WITH NEW INSTRUMENTS, THE SURGEON FINALLY GAVE UP AND SAID TO GO MANUALLY. RESOLUTION: DURING INVESTIGATION, SYSTEM UTILITIES SHOWED THAT J6 WAS THE JOINT THAT WAS HAVING ARM INCONSISTENCY ERRORS IN THE SYSTEM LOGS. REMOVED J6 PROTECTIVE COVER OF J6 GLASS ENCODER AND FOUND BLOOD/TISSUE ON THE ENCODER CAUSING ENCODER COUNTS TO STOP ON THE JOINT AND THEN THE SYSTEM ERROR: JOINT INCONSISTENCY ERROR WOULD OCCUR AND LOCK THE ARM. THOROUGHLY CLEANED THE J6 GLASS ENCODER. CHECKED J6 ENCODER READ HEAD WITH SMART PRECISION SOFTWARE TOOL, CHECKED GOOD. ALL SYSTEM CHECKS AND TESTS PASSED, SYSTEM IS READY FOR PATIENT USE.

    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

    GSP (B)(4): MPS (B)(6) REPORTED SYSTEM HAS HAD MULTIPLE JOINT ANGLES INCONSISTENT ERRORS. TKA. SURGICAL DELAY <30 MIN. PATIENT WAS UNDER ANESTHESIA AT THE TIME OF THE ISSUE. AFTER MANY TIMES TRYING TO REGISTER THE ROBOT WITH NEW INSTRUMENTS, THE SURGEON FINALLY GAVE UP AND SAID TO GO MANUALLY. RESOLUTION: DURING INVESTIGATION, SYSTEM UTILITIES SHOWED THAT J6 WAS THE JOINT THAT WAS HAVING ARM INCONSISTENCY ERRORS IN THE SYSTEM LOGS. REMOVED J6 PROTECTIVE COVER OF J6 GLASS ENCODER AND FOUND BLOOD/TISSUE ON THE ENCODER CAUSING ENCODER COUNTS TO STOP ON THE JOINT AND THEN THE SYSTEM ERROR: JOINT INCONSISTENCY ERROR WOULD OCCUR AND LOCK THE ARM. THOROUGHLY CLEANED THE J6 GLASS ENCODER. CHECKED J6 ENCODER READ HEAD WITH SMART PRECISION SOFTWARE TOOL, CHECKED GOOD. ALL SYSTEM CHECKS AND TESTS PASSED, SYSTEM IS READY FOR PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036 ASSEMBLY-ROTARY SCALE: 190-00126 STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization