BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIO® DRAPE KIT-ONE PIECE WITH POCKETS-

    MDR report key: 7320043 · Received March 7, 2018

    Report

    Report Number
    3005985723-2018-00096
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    February 5, 2018
    Report Date
    June 28, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170581
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE. REPORTED EVENT: HOLE IN DRAPE NOTICED WHILE DRAPING. LIKELY HOLE PRESENT PRIOR TO PLACING DRAPE ON; POSSIBLE MANUFACTURING ERROR AS THERE WAS REMNANTS OF GLUE PRESENT ON OPPOSITE SIDE OF DRAPE TO CIRCULAR PLASTIC SECTION ON END OF DRAPE, CAUSING DRAPE TO STICK TOGETHER AND WHEN SEPARATED CAUSED HOLE IN DRAPE. DELAY IN SURGERY AS HAD TO RE DRAPE ROBOT AND WAIT FOR EXTRA EQUIPMENT TO BE STERILIZED. TKA PROCEDURE, DELAYED AS THE INSTRUMENTS HAD TO BE RE-STERILIZED; APPROXIMATELY 1 HOUR DELAY AND THE PATIENT WAS UNDER ANESTHESIA DURING THE REPORTED DELAY; THE SPINAL BLOCK HAD ALREADY BEEN UNDERTAKEN. PICTURE OF THE DRAPE WAS PROVIDED. REFER TO THE COMMUNICATION LOG. DEVICE EVALUATION AND RESULTS: PRODUCT WAS DISCARDED BY CUSTOMER AND NOT AVAILABLE FOR INSPECTION. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 600 DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 08/18/17. NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. PLEASE SEE ATTACHED FIRST ARTICLE INSPECTION AND IN PROCESS INSPECTION RECORDS. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 111320, LOT NUMBER D172271 SHOWS 0 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. IF DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. 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

    HOLE IN DRAPE NOTICED WHILE DRAPING. LIKELY HOLE PRESENT PRIOR TO PLACING DRAPE ON; POSSIBLE MANUFACTURING ERROR AS THERE WAS REMNANTS OF GLUE PRESENT ON OPPOSITE SIDE OF DRAPE TO CIRCULAR PLASTIC SECTION ON END OF DRAPE, CAUSING DRAPE TO STICK TOGETHER AND WHEN SEPARATED CAUSED HOLE IN DRAPE. DELAY IN SURGERY AS HAD TO RE DRAPE ROBOT AND WAIT FOR EXTRA EQUIPMENT TO BE STERILIZED. TKA PROCEDURE, DELAYED AS THE INSTRUMENTS HAD TO BE RE-STERILIZED; APPROXIMATELY 1 HOUR DELAY AND THE PATIENT WAS UNDER ANESTHESIA DURING THE REPORTED DELAY; THE SPINAL BLOCK HAD ALREADY BEEN UNDERTAKEN. PICTURE OF THE DRAPE WAS PROVIDED. REFER TO THE COMMUNICATION LOG.

    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

    HOLE IN DRAPE NOTICED WHILE DRAPING. LIKELY HOLE PRESENT PRIOR TO PLACING DRAPE ON; POSSIBLE MANUFACTURING ERROR AS THERE WAS REMNANTS OF GLUE PRESENT ON OPPOSITE SIDE OF DRAPE TO CIRCULAR PLASTIC SECTION ON END OF DRAPE, CAUSING DRAPE TO STICK TOGETHER AND WHEN SEPARATED CAUSED HOLE IN DRAPE. DELAY IN SURGERY AS HAD TO RE DRAPE ROBOT AND WAIT FOR EXTRA EQUIPMENT TO BE STERILIZED. TKA PROCEDURE, DELAYED AS THE INSTRUMENTS HAD TO BE RE-STERILIZED; APPROXIMATELY 1 HOUR DELAY AND THE PATIENT WAS UNDER ANESTHESIA DURING THE REPORTED DELAY; THE SPINAL BLOCK HAD ALREADY BEEN UNDERTAKEN. PICTURE OF THE DRAPE WAS PROVIDED. REFER TO THE COMMUNICATION LOG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164673 RIO® DRAPE KIT-ONE PIECE WITH POCKETS- STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. D172271

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization