BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLUSON P6 W/RIC5-9W-RS PROBE

    MDR report key: 6156898 · Received December 8, 2016

    Report

    Report Number
    8020021-2016-00003
    Event Type
    Injury
    Date Received
    December 8, 2016
    Date of Event
    November 9, 2016
    Report Date
    November 9, 2016
    Manufacturer
    KRETZ GE HEALTHCARE AUSTRIA GMBH & CO OG
    Product Code
    IYN
    PMA / PMN Number
    K122387
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI NOT REQUIRED BECAUSE THIS IS A CLASS II DEVICE AND THE DATE OF MANUFACTURE IS PRIOR TO 24-SEPT2016. DEVICE RETURNED TO MANUFACTURER AND IS CURRENTLY UNDER EVALUATION. THE DATE OF DEVICE MANUFACTURE IS UNAVAILABLE AT TIME OF MDR FILING. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED AFTER THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    UPDATED WITH MANUFACTURE DATES. PROBE SERIAL # (B)(4), DATE OF MANUFACTURE IS 13-MAY2014 AND PROBE SERIAL (B)(4), DATE OF MANUFACTURE IS 01-APR2015. THE PROBES WERE REPLACED TO CORRECT THIS ISSUE, GES INVESTIGATION HAS CONCLUDED AND THE RESULTS ARE AS FOLLOWS: BOTH PROBES HAD BEEN MECHANICALLY DAMAGED (DROPPED) PRIOR TO USE, AND THE 3D SCAN HEAD COULD NOT PROPERLY CALIBRATE CAUSING THE "VIRTUAL GUIDE" TO BE OFFSET. THE USER WAS ABLE TO DETECT THE DAMAGE VIA A FAILED CALIBRATION MESSAGE, AND THE USER DECIDED TO CONTINUE TO OPERATE/USE THE DAMAGED PROBES. THEREFORE THE INJURIES WERE DUE TO CONTINUED USE OF A DAMAGED & MALFUNCTIONING PROBE DESPITE BEING WARNED OF THE MALFUNCTION. FURTHER ANALYSIS OF MALFUNCTION COMPLAINT DATA AND DESIGN DOCUMENTATION INDICATES THE PROBABILITY OF REOCCURRENCE IS REMOTE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE PATIENTS EACH WERE INJURED ON SEPARATE DATES. THIS REPORT REPRESENTS THE FIRST PATIENT INJURY, PATIENT A. THE RIC5-9W-RS ULTRASOUND PROBE, ALONG WITH A VOLUSON P6, BIOPSY NEEDLE EBT 00230S-0 ((B)(4)), AND A BIOPSY GUIDE OF UNKNOWN TYPE WERE BEING USED TO ASSIST AN OVARIAN BIOPSY FOR HARVESTING OOCYTES WHEN THE OVARY WAS PUNCTURED AND/OR TORN WITH THE BIOPSY NEEDLE. SURGERY, CELIOGRAPHY, WAS REQUIRED IN ORDER TO STOP THE INTERNAL BLEEDING. THE USER REPORTED THAT THE VIRTUAL GUIDE FOR THE NEEDLE WAS OFFSET AND THEREFORE NEEDLE PLACEMENT WAS INCORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804397 VOLUSON P6 W/RIC5-9W-RS PROBE ULTRASONIC DIAGNOSTIC TRANSDUCER IYN KRETZ GE HEALTHCARE AUSTRIA GMBH & CO OG RIC5-9W-RS PROBE 175616KR2/190438KR2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other