BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOSURG SCISSORS 5 MM O.D., NON HF SERIES

    MDR report key: 5267055 · Received December 4, 2015

    Report

    Report Number
    8010047-2015-01191
    Event Type
    Malfunction
    Date Received
    December 4, 2015
    Date of Event
    November 12, 2015
    Report Date
    November 13, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    LFL
    PMA / PMN Number
    K021962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. WHEN THE OUTPUT WAS ACTIVATED WITH THIS DEVICE, ULTRASONIC OUTPUT WARNING LAMP DIDN'T LIGHT UP. THERE WAS A SCRATCH AT THE TIP OF THE PROBE, AND THE TIP OF THE GRASPING SURFACE WAS SEVERELY WORN AND METAL PART WAS EXPOSED. THE SCRATCH ON THE PROBE AND THE WORN AREA ON THE GRASPING SURFACE WERE RESPECTIVELY LOCATED WHERE THEY WOULD COME INTO CONTACT WITH EACH OTHER. THE MANUFACTURING HISTORY OF THE SUBJECT DEVICE WAS REVIEWED, WITH NO IRREGULARITIES THAT RELATED TO THIS PHENOMENON NOTED. THIS TYPE OF THE DAMAGE IS MOST LIKELY RELATED TO THE OPERATOR'S TECHNIQUE. BASED ON THE PAST SIMILAR CASES, IT IS KNOWN THAT THE GRASPING SURFACE BECOMES SEVERELY WORN AND METAL PART BECOMES EXPOSED DUE TO THE CONTINUED ACTIVATION OF OUTPUT WHILE THE GRASPING SECTION IS CLOSED WITHOUT GRASPING ANY TISSUES. ALSO IT IS KNOWN THAT ULTRASONIC OUTPUT WARNING LAMP LIGHTS UP WHEN THE TIP OF THE PROBE CONTACTS THE EXPOSED METAL PART OF THE GRASPING SURFACE DIRECTLY. THE INSTRUCTION MANUAL OF THIS DEVICE INDICATED BELOW. DO NOT ACTIVATE OUTPUT WHEN CLOSING THE INSTRUMENT AND NOTHING IS GRASPED BETWEEN THE GRASPING SECTION AND THE PROBE, OR WHEN IT IS NOT POSSIBLE TO CONFIRM THAT THE TISSUE BEING GRASPED HAS BEEN COMPLETELY RESECTED. OTHERWISE, ABNORMAL HEAT GENERATED BY FRICTION BETWEEN THE GRASPING SECTION AND THE PROBE MAY DAMAGE THE GRASPING SECTION, OR CAUSE IT TO DETACH OR PREMATURE WEAR IN THE GRASPING SURFACE. IF THE ULTRASONIC OUTPUT STOPS DURING THE PROCEDURE, IT CAUSES THE ULTRASONIC OUTPUT WARNING LAMP OF THE GENERATOR(SONOSURG-G2) TO LIGHT UP AND A WARNING TONE TO SOUND. IMMEDIATELY REMOVE THE INSERTION SECTION OF THE INSTRUMENT FROM THE PATIENT WITH THE TRANSDUCER AND CONNECTION CABLE CONNECTED, AND INSPECT IT ACCORDING TO THE INSTRUCTIONS GIVEN IN SECTION 8.2, "WHEN THE ULTRASONIC OUTPUT WARNING LAMP LIGHTS" ON PAGE 83. OTHERWISE, PATIENT INJURY COULD OCCUR.

    Description of Event or Problem · 1

    THE SUBJECT DEVICE WAS USED DURING A PARTIAL MASTECTOMY, THIS PROCEDURE WAS COMPLETED. WHEN THE USER CHECKED THIS DEVICE AFTER USE, ULTRASONIC OUTPUT WARNING LAMP LIGHTED UP ON THE FRONT PANEL OF SONOSURG-G2 SET THAT WAS USED TOGETHER. THEN, THIS DEVICE WAS CHECKED AT THE OLYMPUS BRANCH, BUT THIS PHENOMENON WAS NOT DUPLICATED. IT IS CONFIRMED THAT THE TIP OF THE GRASPING SURFACE WAS SEVERELY WORN AND METAL PART WAS EXPOSED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798117 SONOSURG SCISSORS 5 MM O.D., NON HF SERIES ULTRASONIC SURGICAL SYSTEM SONOSURG LFL OLYMPUS MEDICAL SYSTEMS CORP. T3775

    Patients

    Seq Age Sex Outcome Treatment
    1