BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA ONE

    MDR report key: 8361624 · Received February 22, 2019

    Report

    Report Number
    3009185973-2019-00061
    Event Type
    Injury
    Date Received
    February 22, 2019
    Date of Event
    January 24, 2019
    Report Date
    September 25, 2019
    Manufacturer
    MEDTECH SA
    Product Code
    OLO
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING A SURGERY, A CANNULA GOT STUCK IN THE CANNULA ADAPTOR. A REVIEW OF THE DHR DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A REVIEW OF THE COMPLAINTS THAT OCCURRED IN THE PAST 12 MONTHS AND OF THE TWO LAST COMPLAINTS RECEIVED FOR THIS DEVICE DETERMINED THAT TWO SIMILAR COMPLAINTS WERE RECEIVED AFTER THE NOTIFICATION DATE. ANALYSIS OF THE RETURNED PRODUCT WAS PERFORMED AND SHOWED THAT TWO SCRATCHES ARE VISIBLE INSIDE THE HOLDER AND A FUNCTIONAL TEST SHOWED THAT IT WAS IMPOSSIBLE TO INSERT A CANNULA IN THE HOLDER. THE MOST PROBABLE ROOT CAUSE IS THAT SOMETHING SHARP ON THE CANNULA MADE THE SCRATCHES THAT ARE PRESENT INSIDE THE CANNULA HOLDER. PRODUCT INFORMATION PROVIDED IN THE PREVIOUS MEDWATCH ARE THE DATA OF THE CORE DEVICE. PRODUCT INFORMATION WAS CORRECTED TO GIVE THE INFORMATION OF THE CANULA THAT WAS ANALYZED AT MANUFACTURING SITE. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CANNULAS WERE BLOCKED INSIDE THEIR INSTRUMENT HOLDERS. THIS OCCURRED WITH SEVERAL SETS OF INSTRUMENTS THAT DAY. REPORTEDLY, THE SURGERY WAS DELAYED BY 3H (TOTAL SURGERY TIME : 6H INSTEAD OF 3H), WHICH IS CONSIDERED AS A SERIOUS INJURY. NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED OTHER THAN THE DELAY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. THE DEVICE MODEL ROSA ONE IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA SPINE, CLASSIFIED OLO AND CLEARED UNDER K151511.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CANNULAS WERE BLOCKED INSIDE THEIR INSTRUMENT HOLDERS. THIS OCCURRED WITH SEVERAL SETS OF INSTRUMENTS THAT DAY. REPORTEDLY, THE SURGERY WAS DELAYED BY 3H (TOTAL SURGERY TIME: 6H INSTEAD OF 3H), WHICH IS CONSIDERED AS A SERIOUS INJURY. NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED OTHER THAN THE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154328 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE OLO MEDTECH SA LONG SPINE INSTRUMENT ADAPTOR ROSA3-120B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other