BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 15294731 · Received August 25, 2022

    Report

    Report Number
    1418479-2022-00024
    Event Type
    Injury
    Date Received
    August 25, 2022
    Report Date
    August 25, 2022
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FJL
    UDI-DI
    04055207065464
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DEVICE INVESTIGATION RESULTS: (B)(4) INVESTIGATION REPORT DEVICE EVALUATION, FORM 5020 (12) THE DEVICE WAS TESTED VISUALLY AND MECHANICALLY. THE REPORTED CONDITION WAS CONFIRMED AND THE DEVICE DID NOT MEET SPECIFICATIONS. THE EVALUATION FOUND THAT THE DAMAGE IS CONSISTENT WITH AN IMPACT AGAINST A HARD SURFACE. DAMAGE MAY HAVE CAUSED A THIN FRACTURE THAT HELD TOGETHER UNTIL THERE WAS STRESS ON THE DEVICE DURING USE INSTEAD OF BREAKING APART IMMEDIATELY. THE INSTRUCTION MANUAL GA-D366-US / EN / 2017-02 V4.0 / ECO 2016-0202 CONTAINS THE FOLLOWING APPLICABLE WARNINGS FOR THESE FAULTS: 8 CHECKS. CAUTION! BE CAREFUL IF PRODUCTS ARE DAMAGED OR INCOMPLETE! INJURIES OF THE PATIENT, USER AND OTHERS ARE POSSIBLE. RUN THROUGH THE CHECKS BEFORE AND AFTER EACH USE. DO NOT USE THE PRODUCTS IF THEY ARE DAMAGED, INCOMPLETE OR HAVE LOOSE PARTS. RETURN DAMAGED PRODUCTS TOGETHER WITH ANY LOOSE PARTS FOR REPAIR. DO NOT ATTEMPT TO DO ANY REPAIRS YOURSELF. 8.1 VISUAL CHECK: CHECK PRODUCTS AND ACCESSORIES FOR DAMAGE, SHARP EDGES, LOSE OR MISSING PARTS AND ROUGH SURFACES. CHECK THE INSULATION WITH PARTICULAR CARE. ANY LETTERING, LABELING OR IDENTIFICATION NECESSARY FOR THE SAFE INTENDED USE MUST BE LEGIBLE. TO PREVENT WRONG HANDLING OR REPROCESSING, ANY ILLEGIBLE LETTERING, LABELING OR IDENTIFICATION MUST BE REINSTATED. USE NEW STERILE ELECTRODES. 8.1.2 "SHARK" RESECTOSCOPE: WARNING! DANGER OF INJURY! INCORRECT HANDLING, E.G. FALL, SHOCK, BLOWS OR SIMILAR MECHANICAL LOADS CAN CAUSE HAIR CRACKS AND / OR SPALLING OF THE CERAMIC COATING IN THE DISTAL AREA OF THE RESECTOSCOPE SHEATH. INJURIES OF THE PATIENT, USER OR THIRD PARTIES ARE POSSIBLE. MIND SURFACE CHANGES AND ENSURE SAFE HANDLING. DO NOT USE DAMAGED RESECTOSCOPE SHEATHS, RETURN DAMAGED SHEATHS FOR REPAIR. CHECK THE CERAMIC INSULATION AT THE DISTAL END OF THE RESECTOSCOPE SHEATH FOR DAMAGE BEFORE EVERY USE. 9.4 REPROCESSING PROCEDURE: IMPORTANT! IF THE INSTRUMENT IS USED AS INTENDED AND PROVIDED THAT THE MANUFACTURER'S MANUAL IS FOLLOWED, IT IS NOT NECESSARY TO LIMIT THE NUMBER OF POSSIBLE REPROCESSING CYCLES. CAREFUL AND GENTLE HANDLING OF MEDICAL PRODUCTS DURING THE ENTIRE REPROCESSING PROCESS HAS AN ESSENTIAL INFLUENCE ON THE SERVICE LIFE OF THE PRODUCTS. BEFORE RETURNING DEFECTIVE PRODUCTS FOR REPAIR, THEY MUST HAVE BEEN SUBJECTED TO THE ENTIRE REPROCESSING CYCLE. THE USER MUST ENSURE THAT THE REPROCESSING PROCESS INCLUDING THE RESOURCES, MATERIALS AND PERSONNEL ARE SUITABLE TO ACHIEVE THE REQUIRED RESULTS. COMPLY WITH THE NATIONAL AND INTERNATIONAL REQUIREMENTS REGARDING THE VALIDATION OF THE USER'S REPROCESSING PROCESS. IMPORTANT! DO NOT STERILIZE THE PRODUCTS IN HOT-AIR STERILIZERS. ADDITIONALLY, ON AUGUST 23, 2022, A FOLLOW-UP EMAIL WAS SENT TO THE USER FACILITY TOGETHER WITH THE SALES REPRESENTATIVE REGARDING THE PATIENT INFORMATION. HOWEVER, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. (EMAIL REPLY, 8/24/2022). RW CONSIDERS THIS MATTER CLOSED. HOWEVER, IF A NEW INFORMATION BECOMES AVAILABLE, RW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 0

    (B)(4) REFERENCE COMPLAINT NO. (B)(4). ON (B)(6) 2022, IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) BY A USER FACILITY REPRESENTATIVE THAT PRODUCT ID# 86753225 LOT 1498308 SHEATH HAS A BROKEN BEAK. THE BEAK BROKE OFF INSIDE PATIENT. ALL PIECES WERE RETRIEVED. INITIAL INFORMATION REPORTED BY THE USER FACILITY REPRESENTATIVE: (EMAIL, DATED (B)(6) 2022) "A PERSON JUST BROUGHT ME THE 86753225 LOT 1498308 SHEATH WITH THE BROKEN BEAK. HE REPORTED THE PIECE BROKE OFF INSIDE THE PATIENT. IT WAS RETRIEVED AND IS IN THE PACKAGE WITH THE BROKEN SHEATH." WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTING ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES. DID THE DELAY PUT THE PATIENT AT RISK? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. ON 22-AUG- 2022, ADDITIONAL INFORMATION'S WERE PROVIDED BY THE INITIAL REPORTER: I. HOW LONG WAS THE PROCEDURE DELAYED? 10 MIN. 2. WHAT ACTIONS WERE BEING DONE DURING THE DELAY? PULLED A BACK UP TRAY. 3. DID THE PATIENT REQUIRE ANY ADDITIONAL TREATMENT DURING THE DELAY OR WILL REQUIRE ANOTHER PROCEDURE AS THE RESULT OF THE DELAY? NO. 4. WHAT WAS THE PATIENT'S OUTCOME? FINISHED THE CASE. RWMIC MDR AWARENESS DATE: 10-AUG-2022. ALSO, THE PURPOSE OF THIS SUBMISSION IS TO PROVIDE THE RESULTS OF THE DEVICE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2490983 NA INNER SHEATH RESECTOSCOPE 22FR FJL RICHARD WOLF GMBH 86753225 1498308 04055207065464

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention