BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA

    MDR report key: 7023243 · Received November 10, 2017

    Report

    Report Number
    1418479-2017-00031
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    September 28, 2017
    Report Date
    October 16, 2017
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC)
    Product Code
    HRX
    UDI-DI
    04055207039762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1, THE FOLLOWING INFORMATION WAS UPDATED / COMPLETED: ADDITIONAL: PATIENT INFORMATION. CORRECTED / CHANGED /REQUIRED BY MISSING DATA REPORT : DESCRIBE EVENT OR PROBLEM, COMMON DEVICE NAME (FDA PRODUCT CODE), CONTACT OFFICE INFORMATION, DATE RECEIVED BY MFR., TYPE OF REPORT, TYPE OF REPORTABLE EVENT, IF FOLLOW-UP, WHAT TYPE? ADDITIONAL MANUFACTURER NARRATIVE AND/OR CORRECTED DATA. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED INFORMATION FROM THE USER FACILITY ON NOVEMBER 13, 2017. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT RWMIC RECEIVES ANY ADDITIONAL INFORMATION A FOLLOW UP REPORT WILL BE SUBMITTED TO FDA.

    Additional Manufacturer Narrative · 1

    A FULL INVESTIGATION COULD NOT BE COMPLETED, AS THE ACTUAL DEVICE WAS NOT RETURNED TO THE RICHARD WOLF FACILITY. HOWEVER, A PHOTO OF BROKE DEVICE WAS SUBMITTED FOR REVIEW. PHOTO SHOWED A BOWED SHAFT AND THE DISTAL END OF CANNULA WAS MISSING. BOWING OF THE SHAFT IS DUE TO EXCESSIVE FORCE APPLIED. IF EXCESSIVE AXIAL FORCE, GREATER THAN 50LB/F (FOOT POUNDS) IS APPLIED, THE CANNULA TIP WILL BREAK. DEVICE MANUFACTURED DATE - SEP2006. DEVICE PURCHASED DATE - A TOTAL OF THREE CANNULAS (LOT #249S06) WERE PURCHASED BY USER FACILITY: 25SEP2006, 04OCT2006, 02NOV2006. SERVICE DATES - NO ENTRIES OF SERVICE PERFORMED. NO SIMILAR COMPLAINT HAVE OCCURRED IN THE LAST THREE YEARS ON THIS DEVICE TYPE. RICHARD WOLF CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT THE DEVICE IS RETURNED OR ADDITIONAL INFORMATION IS RECEIVED, RWMIC WILL PROVIDE FDA WITH A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    FOLLOW UP REPORT #1.

    Description of Event or Problem · 1

    USER FACILITY NOTIFIED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) THAT AFTER REMOVING CANNULA FROM PATIENT DURING A PROCEDURE, IT WAS NOTICED THE CANNULA WAS BROKEN. ACCORDING TO USER FACILITY, CANNULA BROKE APPROXIMATELY ONE INCH FROM DISTAL END. A SIMILAR BACK UP DEVICE WAS AVAILABLE FOR USE AND PROCEDURE COMPLETED AS SCHEDULED. AFTER PROCEDURE WAS COMPLETED, X-RAY WAS PERFORMED ON PATIENT TO ENSURE NO FOREIGN OBJECTS REMAINED. NO INJURY TO PATIENT OR STAFF REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802528 CANNULA CANNULA HRX RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) 830209 249S06 04055207039762

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR