BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIO® DRAPE KIT-ONE PIECE WITH POCKETS-

    MDR report key: 8573056 · Received May 2, 2019

    Report

    Report Number
    3005985723-2019-00330
    Event Type
    Malfunction
    Date Received
    May 2, 2019
    Date of Event
    April 12, 2019
    Report Date
    November 8, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K050322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT THE DRAPE WAS DAMAGED DURING INSTALLATION. PRODUCT EVALUATION AND RESULTS: THE PRODUCT WAS NOT EVALUATED AS THE PRODUCT WAS UNAVAILABLE FOR INSPECTION. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 720 DEVICES WERE MANUFACTURED UNDER LOT NO D182631 AND ACCEPTED INTO FINAL STOCK ON 09/22/2018. NO NON-CONFORMANCE WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 2053545, LOT D182631 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE FAILURE COULD NOT BE DETERMINED AS THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN NO NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    (B)(4), MAKO PRODUCT SPECIALIST REPORTED THE FOLLOWING EVENT : "THE STERILE PROTECTIVE SHEET OF THE MAKO ROBOT HAD A HOLE IN ITS OPENING. NOT ITS PACKAGING. A SECOND SHEET HAD TO BE OPENED TO START THE SURGERY. WHAT MEASURES/ACTIONS HAVE BEEN TAKEN TO COMPLETE THE INTERVENTION? A SECOND SHEET WAS OPENED." PATIENT IN THE OR AT THE TIME OF DISCOVERY: PATIENT UNDER ANAESTHESIA. CASE TYPE: TKA.

    Additional Manufacturer Narrative · 1

    AS PART OF THE 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), MAKO PRODUCT SPECIALIST REPORTED THE FOLLOWING EVENT: "THE STERILE PROTECTIVE SHEET OF THE MAKO ROBOT HAD A HOLE IN ITS OPENING, NOT ITS PACKAGING. A SECOND SHEET HAD TO BE OPENED TO START THE SURGERY. WHAT MEASURES/ACTIONS HAVE BEEN TAKEN TO COMPLETE THE INTERVENTION? A SECOND SHEET WAS OPENED." PATIENT IN THE OPERATING ROOM AT THE TIME OF DISCOVERY. PATIENT UNDER ANAESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365803 RIO® DRAPE KIT-ONE PIECE WITH POCKETS- STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. D182631

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization