BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPS ASSY

    MDR report key: 8431795 · Received March 19, 2019

    Report

    Report Number
    3005985723-2019-00248
    Event Type
    Malfunction
    Date Received
    March 19, 2019
    Date of Event
    February 20, 2019
    Report Date
    April 23, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: MPS REPORTED PERIPHERAL CONNECTION ERROR. DEVICE INSPECTION: PER GSP CASE #: (B)(4). FSE NOTED: THE REPORTED PROBLEMS OCCUR RANDOMLY. I RAN PRE SURGERY CHECK THREE TIMES SHUTTING DOWN THE ROBOT EACH TIME. THERE WERE NO ERRORS. I TIMED THE BATTERIES AT GREATER THAN 2 MINUTES OF HOLDING POWER. I REVIEWED THE LOG FILES AND FOUND MULTIPLE UPS AND ANSPACH ERRORS. I CONSULTED WITH (B)(6) WHO WAS ON SITE AND WE AGREED TO INSTALL NEW UPS, ANSPACH, AND CPCI MOTION CONTROL BOX AND ISOLATION STATION. AFTER THE INSTALLATION AND CHECKOUT PER THE SERVICE MANUAL, (B)(6) AND I WENT TO OR 8 WHERE WE ASSISTED (B)(6) WITH A SAWBONES. THE ONLY THING THE ROBOT DID WAS SHOW A BOOST LIGHT ON THE UPS. THE SAWBONES HAD NO ERRORS AND WAS COMPLETED SUCCESSFULLY. WE INSPECTED THE LOG FILES AND FOUND NO UPS OR ANSPACH ERRORS. I SHOWED BOTH (B)(6) AND (B)(6) HOW TO INSTALL THE VOLTAGE LINE MONITOR WHILE THE ROBOT IS OPERATING. ON(B)(6) 2019 I DISCUSSED THE OR 8 BOOST LIGHT THAT CAME ON WITH THE ROBOT AND THE ELECTRICAL OUTLETS WITH (B)(6) THE ELECTRICIAN. THE PARTS INSTALLED ARE: UPS- P/N 207563, ANSPACH- P/N 209780, CPCI MOTION CONTROL- 211123, 201099- ISOLATION STATION. THE ROBOT IS READY FOR CLINICAL USE. DEVICE HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 04/16/2010 1 DEVICE WAS INSPECTED AND 1 DEVICE WAS PLACED ON: NPR 10-03-0016, 10-04-0065, 10-04-0025, 10-04-0028, 10-04-0012, 10-03-0060 10-04-0031, 10-04-0062, 10-04-0044, 10-02-0097, 10-04-0104. A REVIEW OF THE DATA REVEALED THAT THE NON-CONFORMANCES ARE NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO UPS ASSY, CATALOG #: 207563 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION: THE FSE REPLACED THE UPS ASSEMBLY. THE SYSTEM PASSED ALL STATUS CHECKS AND IS READY FOR CLINICAL USE. FURTHER ACTION: NONE AT THIS TIME.

    Description of Event or Problem · 0

    ROB094 - PERIPHERAL CONNECTION ERROR. CASE TYPE: TKA. SURGICAL DELAY- ABOUT 20-30 MINUTES. WAS THE PATIENT UNDER ANESTHESIA DURING THE DELAY? YES/NO. AS PER THE MPS: YES THE PATIENT WAS UNDER ANESTHESIA. AS PER THE MPS: THE CASE WAS NOT CANCELLED, BUT WAS COMPLETED MANUALLY.THE ROBOT WAS NOT ALLOWING US TO EVEN HOME THE ROBOT AND AFTER MULTIPLE TROUBLE SHOOTING STEPS WE WERE FORCED TO GO MANUAL. DESCRIPTION OF EVENT: MPS CALLED WHILE OTHER MPS ALSO CALLED (B)(6) ABOUT PERIPHERAL CONNECTION ERROR. FROM SUGGESTION OF SAM, THEY WERE ALREADY RELOADING APPLICATION SOFTWARE. TROUBLESHOOTING STEPS TAKEN: ASKED MPS IF CABLES HAD BEEN CLEANED, WHICH THEY HADN'T BEEN CLEANED BETWEEN CASES WITH ROBOT CHANGING ROOMS. AFTER TWO CLEANINGS, ERROR PERSISTED, AND THEN MPS WENT TO DO A DOUBLE BY PASS WHICH FAILED. RESTARTING ARM SOFTWARE WAS ALSO GIVING A PERIPHERAL CONNECTION ERROR. MPS TEAM ATTEMPTED ANOTHER RELOAD OF APPLICATION SOFTWARE, AND I ALSO ASKED THEM TO CLEAN ONE MORE TIME THOROUGHLY, USING ALL TOOLS AVAILABLE. DISPOSITION OF CALL: STILL COULD NOT CLEAR PERIPHERAL CONNECTION ERROR. FSE ESCALATION REQUIRED: YES. THE REPORTED PROBLEMS OCCUR RANDOMLY. I RAN PRE SURGERY CHECK THREE TIMES SHUTTING DOWN THE ROBOT EACH TIME. THERE WERE NO ERRORS. I TIMED THE BATTERIES AT GREATER THAN 2 MINUTES OF HOLDING POWER. I REVIEWED THE LOG FILES AND FOUND MULTIPLE UPS AND ANSPATH ERRORS. I CONSULTED WITH (B)(6) WHO WAS ON SITE AND WE AGREED TO INSTALL NEW UPS, ANSPATCH, AND CPCI MOTION CONTROL BOX AND ISOLATION STATION. AFTER THE INSTALLATION AND CHECKOUT PER THE SERVICE MANUAL, (B)(6) AND I WENT TO OR 8 WHERE WE ASSISTED (B)(6) WITH A SAWBONES. THE ONLY THING THE ROBOT DID WAS SHOW A BOOST LIGHT ON THE UPS. THE SAWBONES HAD NO ERRORS AND WAS COMPLETED SUCCESSFULLY. WE INSPECTED THE LOG FILES AND FOUND NO UPS OR ANSPACTH ERRORS. I SHOWED BOTH (B)(6) AND (B)(6) HOW TO INSTALL THE VOLTAGE LINE MONITOR WHILE THE ROBOT IS OPERATING. ON (B)(6) 2019 I DISCUSSED THE OR 8 BOOST LIGHT THAT CAME ON WITH THE ROBOT AND THE ELECTRICAL OUTLETS WITH DREW THE ELECTRICIAN. THE PARTS INSTALLED ARE: UPS- P/N 207563, ANSPACH- P/N 209780, CPCI MOTION CONTROL- 211123, 201099- ISOLATION STATION. THE ROBOT IS READY FOR CLINICAL US.

    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

    (B)(4) - PERIPHERAL CONNECTION ERROR. CASE TYPE: TKA. SURGICAL DELAY- ABOUT 20-30 MINUTES. WAS THE PATIENT UNDER ANESTHESIA DURING THE DELAY? YES/NO. AS PER THE MPS: YES THE PATIENT WAS UNDER ANESTHESIA. AS PER THE MPS: THE CASE WAS NOT CANCELLED, BUT WAS COMPLETED MANUALLY. THE ROBOT WAS NOT ALLOWING US TO EVEN HOME THE ROBOT AND AFTER MULTIPLE TROUBLE SHOOTING STEPS WE WERE FORCED TO GO MANUAL. DESCRIPTION OF EVENT: MPS CALLED WHILE OTHER MPS ALSO CALLED (B)(4) ABOUT PERIPHERAL CONNECTION ERROR. FROM SUGGESTION OF (B)(4), THEY WERE ALREADY RELOADING APPLICATION SOFTWARE. TROUBLESHOOTING STEPS TAKEN: ASKED MPS IF CABLES HAD BEEN CLEANED, WHICH THEY HADN'T BEEN CLEANED BETWEEN CASES WITH ROBOT CHANGING ROOMS. AFTER TWO CLEANINGS, ERROR PERSISTED, AND THEN MPS WENT TO DO A DOUBLE BY PASS WHICH FAILED. RESTARTING ARM SOFTWARE WAS ALSO GIVING A PERIPHERAL CONNECTION ERROR. MPS TEAM ATTEMPTED ANOTHER RELOAD OF APPLICATION SOFTWARE, AND I ALSO ASKED THEM TO CLEAN ONE MORE TIME THOROUGHLY, USING ALL TOOLS AVAILABLE. DISPOSITION OF CALL: STILL COULD NOT CLEAR PERIPHERAL CONNECTION ERROR. FSE ESCALATION REQUIRED: YES. THE REPORTED PROBLEMS OCCUR RANDOMLY. I RAN PRE SURGERY CHECK THREE TIMES SHUTTING DOWN THE ROBOT EACH TIME. THERE WERE NO ERRORS. I TIMED THE BATTERIES AT GREATER THAN 2 MINUTES OF HOLDING POWER. I REVIEWED THE LOG FILES AND FOUND MULTIPLE UPS AND ANSPACH ERRORS. I CONSULTED WITH (B)(6) WHO WAS ON SITE AND WE AGREED TO INSTALL NEW UPS, ANSPACH, AND CPCI MOTION CONTROL BOX AND ISOLATION STATION. AFTER THE INSTALLATION AND CHECKOUT PER THE SERVICE MANUAL, (B)(6), (B)(6) AND I WENT TO OPERATING ROOM 8 WHERE WE ASSISTED (B)(6) WITH A SAWBONES. THE ONLY THING THE ROBOT DID WAS SHOW A BOOST LIGHT ON THE UPS. THE SAWBONES HAD NO ERRORS AND WAS COMPLETED SUCCESSFULLY. WE INSPECTED THE LOG FILES AND FOUND NO UPS OR ANSPACH ERRORS. I SHOWED BOTH (B)(6) AND (B)(6) HOW TO INSTALL THE VOLTAGE LINE MONITOR WHILE THE ROBOT IS OPERATING. ON (B)(6) 2019 I DISCUSSED THE OPERATING ROOM 8 BOOST LIGHT THAT CAME ON WITH THE ROBOT AND THE ELECTRICAL OUTLETS WITH (B)(6) THE ELECTRICIAN. THE PARTS INSTALLED ARE: UPS- P/N 207563, ANSPACH- P/N 209780, CPCI MOTION CONTROL- 211123, 201099- ISOLATION STATION. THE ROBOT IS READY FOR CLINICAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224878 UPS ASSY STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization