BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRASPING FORCEPS INSERT

    MDR report key: 6906443 · Received September 29, 2017

    Report

    Report Number
    1418479-2017-00023
    Event Type
    Injury
    Date Received
    September 29, 2017
    Date of Event
    September 5, 2017
    Report Date
    September 5, 2017
    Manufacturer
    RICHARD WOLF GERMANY (RWGMBH)
    Product Code
    GEI
    UDI-DI
    04055207015995
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1, THE FOLLOWING WAS UPDATED/COMPLETED: PATIENT INFORMATION, PRODUCT PROBLEM, SUSPECT DEVICE, INITIAL REPORT, IMPORTER (DEVICE), CORRECTED/ADDITIONAL DATA. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED A MEDWATCH (B)(4) FROM USER FACILITY ON 11OCT2017 WITH ADDITIONAL INFORMATION CONCERNING THE EVENT, WHICH OCCURRED ON (B)(6) 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

    FACILITY CALLED (B)(4), DURING A PROCEDURE, TO REPORT THE DEVICE IN QUESTION BROKE. ONE OF THE GRASPING JAWS BROKE OFF AND FACILITY WAS NOT 100% SURE ALL PARTS OF DEVICE HAD BEEN ACCOUNTED FOR. FACILITY REQUESTED DRAWING OF DEVICE AND INDICATED PATIENT WAS IN PROCESS OF BEING X-RAYED IN AN EFFORT TO ASSURE ALL PARTS WERE REMOVED. NO INJURY TO PATIENT REPORTED. FACILITY HAS NOT SUPPLIED THE LOT # OF DEVICE, THEREFORE THE MANUFACTURER DATE, PURCHASE DATE AND SERVICE DATES ARE UNKNOWN AT THIS TIME. FACILITY HAS PURCHASED (B)(4) SIMILAR DEVICES (ID #8393.293) SINCE FEB2014. THERE HAS BEEN ONE SIMILAR INCIDENT,ON THIS SPECIFIC DEVICE (ID #8393.293), IN THE LAST THREE YEARS (MDR #1418479-2014-00045). FACILITY HAS BEEN CONTACTED TWICE, VIA EMAIL, IN AN EFFORT TO GATHER ADDITIONAL AND MISSING INFORMATION FOR THIS REPORT. NO RESPONSE AS OF 09/29/2017. AS OF 29SEP2017, DEVICE HAS NOT BEEN RETURNED TO (B)(4). DEVICE WILL BE SENT TO MANUFACTURER FOR INVESTIGATION IF AND WHEN IT IS RETURNED TO (B)(4). (B)(4) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT (B)(4) RECEIVES ANY ADDITIONAL INFORMATION, (B)(4) WILL PROVIDE THE MANUFACTURER OF DEVICE WITH THE INFORMATION.

    Description of Event or Problem · 1

    FOLLOW UP REPORT #1. PROCEDURE PERFORMED - ROBOTIC TOTAL LAPAROSCOPIC HYSTERECTOMY WITH MORCELLATOR. X-RAY PERFORMED ON PATIENT AND THREE METALLIC DENSITIES WERE FOUND OVER PATIENTS ABDOMEN. FOREIGN OBJECTS WERE LEFT IN PATIENTS ABDOMEN DUE TO RISK OF FURTHER EXPLORATION TO PATIENTS HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686169 GRASPING FORCEPS INSERT GRASPING FORCEPS INSERT GEI RICHARD WOLF GERMANY (RWGMBH) 8393.293 04055207015995

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other