BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASAL FORCEPS

    MDR report key: 2436597 · Received January 20, 2012

    Report

    Report Number
    1418479-2011-00026
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Date of Event
    December 7, 2011
    Report Date
    January 19, 2012
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    KBE
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY DID NOT RETURN THE DEVICE TO RWMIC FOR ANALYSIS, INSTEAD IT WAS SHIPPED TO A 3RD PARTY SERVICE PROVIDER FOR REPAIR. RWMIC RECORDS WERE REVIEWED, THIS FACILITY HAS NOT USED RWMIC AS A SERVICE PROVIDER FOR THIS DEVICE SINCE DISTRIBUTION. INSTRUMENT AGE: 8+ YEARS. DISTRIBUTION DATE: AUGUST 21, 2003. POSSIBLE ROOT CAUSE: IMPROPER MAINTENANCE (NONE, PREVIOUS 3RD PARTY REPAIR) AND/OR PIN CAME LOOSE DURING REPROCESSING OR NORMAL USE. REPROCESSING AS REPORTED BY FACILITY: "ALL INSTRUMENTS THAT CAN BE PROCESSED BY MACHINE FIRST GO THRU A 10 MIN ULTRASONIC CLEANING WITH A NEUTRAL PH CLEANING AGENT." AFTER THIS PROCESS IT GOES THRU THE WASHER AT 170 DEGREES FOR UP TO 45 MINUTES' IT IS THEN VISUALLY INSPECTED, PLACED IN THE ACCEPTABLE CONTAINER OR WRAP PAPER AND STERILIZED AT A 10 MIN / 40 MIN STERILIZATION / DRY TIME AT 274 DEGREES TEMP." LABELING FOR THIS DEVICE WAS REVIEWED, INSTRUCTION G56 INCLUDES THE FOLLOWING: IMPORTANT NOTIFICATIONS: "TO ENSURE MAXIMUM SAFETY, WE STRONGLY RECOMMEND THAT THIS EQUIPMENT BE SENT TO OUR FACILITY PERIODICALLY, DEPENDING ON ITS USE, FOR COMPREHENSIVE INSPECTION." "RICHARD WOLF, AS MANUFACTURER AND SELLER OF THE INSTRUMENTS WHICH ARE THE SUBJECT OF THIS MANUAL, IS NOT RESPONSIBLE FOR ANY DIRECT OR INDIRECT DAMAGES RESULTING FROM IMPROPER OR INCORRECT USE, CARE, OR SERVICING OF THESE INSTRUMENTS, OR FROM THE FAILURE TO FOLLOW THE INSTRUCTIONS IN THIS MANUAL." PROPER CARE AND MAINTENANCE IS IMPORTANT FOR THE EFFICIENT AND SAFE OPERATION OF SOPHISTICATED MEDICAL / SURGICAL EQUIPMENT. WE RECOMMEND CAREFUL INSPECTION OF ALL EQUIPMENT UPON RECEIPT AND PRIOR TO EACH USE AS A SAFEGUARD AGAINST POSSIBLE INJURY TO PATIENT AND/OR OPERATOR. WHEN IN DOUBT AS TO PROPER CARE AND MAINTENANCE PROCEDURES, CONTACT THE RICHARD WOLF CUSTOMER SERVICE DEPARTMENT AT (B)(4) OR CONTACT YOUR LOCAL RICHARD WOLF REPRESENTATIVE." "IF NON-AUTHORIZED PERSONS PERFORM REPAIRS OR MODIFICATIONS OF THIS PRODUCT, RICHARD WOLF DOES NOT ACCEPT LIABILITY AND THE WARRANTY BECOMES VOID. COMPONENTS INFLUENCING SAFETY MAY ONLY BE REPLACED WITH ORIGINAL REPLACEMENT PARTS." CARE AND MAINTENANCE: "ULTRASONIC CLEANING IS RECOMMENDED FOR ALL HAND INSTRUMENTS WITH THE FOLLOWING CAUTIONS: THE VIBRATION ASSOCIATED WITH ULTRASONIC CLEANING MAY LOOSEN LOCK SCREWS ON INSTRUMENTS THAT HAVE THEM." RWMIC CONSIDERS THIS MATTER CLOSED, BUT WILL PROVIDE ADDITIONAL / FOLLOW-UP INFORMATION TO FDA IF RECEIVED OR REQUESTED. RWMIC WILL REPORT OUR FINDING TO FACILITY, WE WILL ALSO INCLUDE A COPY OF INSTRUCTION G56. FACILITY WILL BE CAUTIONED NOT TO USE 3RD PARTY REPAIR FOR "PIN REPLACEMENT," ETC.

    Description of Event or Problem · 1

    THE PITUITARY FORCEPS USED DURING A PROCEDURE BROKE APART WHILE IN USE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: BILATERAL ORBITAL DECOMPRESSION. FACILITY E-MAIL DATE (B)(6) 2012: "NO HARM TO PATIENT." FACILITY ALSO NOTED THAT THE TECHNICIAN NOTICED A PIN MISSING WHEN THE SURGEON HANDED BACK THE INSTRUMENT, THE EYE WAS CHECKED AND THE MISSING PIN WAS NOT FOUND. FACILITY E-MAIL DATED (B)(6) 2012: "PIN WAS MISSING FROM THE TIP OF THE INSTRUMENT, NEAR THE JAW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NASAL FORCEPS NASAL FORCEPS KBE RICHARD WOLF GMBH 8211.101

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other