BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM 3RD EDITION

    MDR report key: 6135750 · Received November 30, 2016

    Report

    Report Number
    1723170-2016-05189
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    August 12, 2015
    Report Date
    November 30, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K092564
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINAL FUSION PROCEDURE, IT WAS DISCOVERED THAT THE TABS INDICATING WHERE THE SCRUB TECH SHOULD PUT THEIR HANDS HAD BEEN TAPED TO THE BOTTOM OF THE IMAGING SYSTEM CAUSING TEARS WHEN OPENING THE DRAPE WHILE CLOSING THE GANTRY. THE SITE HAD TO WASTE THE DRAPE AND OPEN A NEW DRAPE. THE SCRUB TECH HAD TO REPLACE HIS GLOVES BUT THERE WAS NO OTHER CONTAMINATION OF THE STERILE FIELD. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME. A REPLACEMENT DRAPE WAS SENT TO THE SITE WHICH RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED. REPLACED DRAPE WAS NOT RETURNED TO MANUFACTURER FOR ANALYSIS, THEREFORE, NO FINDINGS ARE POSSIBLE. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA NEW ENGLAND DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 FDA-483 FEI: 3004785967. THIS REVIEW WAS PERFORMED AS A RESULT OF RECENT CHANGES/IMPROVEMENTS TO THE MEDTRONIC NAVIGATION, INC. MEDICAL DEVICE REPORT (MDR) REVIEW PROCESS AND IS FOR NON-ADVERSE EVENT REPORTABLE MALFUNCTIONS WITHIN THE LAST TWO YEARS WHERE THE REPORTED MALFUNCTION WAS NOT PREVIOUSLY ASSOCIATED WITH SERIOUS INJURIES. SIMILAR MALFUNCTIONS THAT HAD RESULTED IN SIGNIFICANT DELAYS OF SURGERY OR REQUIRED ADDITIONAL INTERVENTION HAD BEEN REPORTED AS MDR SERIOUS INJURIES. BASED ON THIS 483 OBSERVATION, THE REPORTING DETERMINATION HAS BEEN REVISED TO CONSIDER THESE MALFUNCTION EVENTS REPORTABLE. THIS PROCESS CHANGE RESULTED IN AN OVERALL INCREASE IN THE NUMBER OF MDRS FILED BY MEDTRONIC NAVIGATION, INC., SINCE APRIL 2016. IT SHOULD BE NOTED THAT THIS INCREASE IS NOT THE RESULT OF THE DISCOVERY OF NEW PRODUCT PROBLEMS, BUT RATHER THE RESULT OF A BROADER INTERPRETATION AND APPLICATION OF THE REGULATIONS WITHIN OUR PROCESSES.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINAL FUSION PROCEDURE, IT WAS DISCOVERED THAT THE TABS INDICATING WHERE THE SCRUB TECH SHOULD PUT THEIR HANDS HAD BEEN TAPED TO THE BOTTOM OF THE IMAGING SYSTEM CAUSING TEARS WHEN OPENING THE DRAPE WHILE CLOSING THE GANTRY. THE SITE HAD TO WASTE THE DRAPE AND OPEN A NEW DRAPE. THE SCRUB TECH HAD TO REPLACE HIS GLOVES BUT THERE WAS NO OTHER CONTAMINATION OF THE STERILE FIELD. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785887 O-ARM 1000 IMAGING SYSTEM 3RD EDITION IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC. (LITTLETON) BI-700-00028-120

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR