BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRAIGHT TROCAR SLEEVE

    MDR report key: 6932439 · Received October 9, 2017

    Report

    Report Number
    1418479-2017-00027
    Event Type
    Injury
    Date Received
    October 9, 2017
    Date of Event
    September 6, 2017
    Report Date
    September 18, 2017
    Manufacturer
    RICHARD WOLF GERMANY (RWGMBH)
    Product Code
    FBQ
    UDI-DI
    04055207021996
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #2. THE FOLLOWING SECTIONS UPDATED/ADDED: PRODUCT PROBLEM, SUSPECT DEVICE, IMPORTER (DEVICE), CORRECTED DATA. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED INVESTIGATION RESULTS FROM MANUFACTURER ON 12DEC2017. NO ISSUES WERE FOUND WITH DEVICE WHEN VISUALLY INSPECTION BY THE MANUFACTURER. MANUFACTURER INDICATED THE FOREIGN OBJECT DID NOT COME THE SUSPECT DEVICE. FACILITY WAS CONTACTED SEVERAL TIMES, VIA FAX AND PHONE, IN AN EFFORT GATHER ADDITIONAL/MISSING INFORMATION. NO RESPONSE AS OF 04JAN2018. 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

    FOLLOW UP # 1, THE FOLLOWING WAS UPDATED/ COMPLETED: PATIENT INFORMATION - PATIENT IDENTIFIER, AGE OR DATE OF BIRTH, SEX, WEIGHT. PRODUCT PROBLEM - DATE OF EVENT. SUSPECT DEVICE - BRAND NAME, COMMON DEVICE NAME, DEVICE AVAILABLE FOR EVALUATION. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED AN EMAIL FROM USER FACILITY ON 17 OCT 2017 WITH ADDITIONAL INFORMATION. IN ADDITION, DEVICE WAS RETURNED TO RWMIC AND SENT TO MANUFACTURE ON 03 NOV 2017. NEW INFORMATION ADDED TO THIS FOLLOW UP REPORT. RMIC CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT RWMIC RECEIVES ANY ADDITIONAL INFORMATION A FOLLOW REPORT WILL BE SUBMITTED TO FDA.

    Description of Event or Problem · 1

    FOLLOW UP #2.

    Description of Event or Problem · 1

    FOLLOW UP REPORT #1.

    Description of Event or Problem · 1

    RICHARD WOLF MEDICAL INSTRUMENTS COOPERATION (RWMIC) WAS INFORMED THAT DURING A PROCEDURE A BLACK PLASTIC FOREIGN OBJECT FOUND DURING PROCEDURE. FOREIGN OBJECT WAS EASILY RETRIEVED, BACK UP DEVICE WAS READILY AVAILABLE FOR USE AND PROCEDURE COMPLETED AS SCHEDULED. NO INJURY TO PATIENT OR STAFF REPORTED. DATE RWMIC RECEIVE DEVICE: 02MAR2017. DATE FACILITY PURCHASED DEVICE: 26JUL2017. SERVICE DATES: N/A. DEVICE APPROXIMATELY 7 MONTHS OLD. FACILITY HAS BEEN CONTACTED, VIA PHONE AND EMAIL, IN AN EFFORT TO GATHER ADDITIONAL/MISSING FOR MEDWATCH REPORT. NO RESPONSE RECEIVED AS OF 09OCT2017. NO SIMILAR COMPLAINTS HAVE BEEN REPORTED ON THIS DEVICE TYPE IN THE LAST THREE YEARS. DEVICE HAS NOT BEEN RETURNED. ONCE RWMIC RECEIVES DEVICE, IT WILL BE SENT TO MANUFACTURER FOR INVESTIGATION. RWMIC CONSIDERS THIS REPORT CLOSED. IF RWMIC RECEIVES ADDITIONAL INFORMATION REGARDING THIS INCIDENT, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707952 STRAIGHT TROCAR SLEEVE TROCAR SLEEVE FBQ RICHARD WOLF GERMANY (RWGMBH) 8919.333 1333148 04055207021996

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other