BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 11675796 · Received April 15, 2021

    Report

    Report Number
    1418479-2021-00012
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Report Date
    July 27, 2022
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    HHI
    UDI-DI
    04055207040003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    RICHARD WOLF MEDICAL INSTRUMENTS (RWMIC) IS SUBMITTING THIS MDR ON BEHALF OF THE DEVICE MANUFACTURER, RW GMBH. FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH NEW AND CORRECTED INFORMATIONS ABOUT THIS MDR. THE FOLLOWING FIELDS HAVE: NEW INFORMATION: B4, B5, D8, E1, E2, E3, G6, H2, H7, AND H10. CORRECTED INFORMATION: D4, G3, H3, H6-INVESTIGATION FINDINGS. RESULTS OF THE DEVICE PRODUCT HISTORY EVALUATION: THE DEVICE WAS NOT RETURNED INSTEAD, A PRODUCT HISTORY EVALUATION WAS PERFORMED. ACCORDING TO THE INVESTIGATION REPORT PRODUCT HISTORY EVALUATION , FORM 5253 (00): (04/19/2021) RWGMBH HAS NOT RECEIVED SIMILAR COMPLAINTS ABOUT THE PRODUCT 8378.00. IN THE LAST 10 YEARS THE ONLY ONE COMPLAINT WAS FROM RWMIC (19-00178) BUT WITH ANOTHER PROBLEM DESCRIPTION: "TIP INSIDE THE PATIENT". THERE IS NO FURTHER INFORMATION IN THE COMPLAINT RECORDS. BASED ON THE AVAILABLE RESULTS, THERE ARE NO SIGNS OF SYSTEMATIC PROBLEMS. NO FURTHER ACTION IS REQUIRED. RWGMBH HAS REVISED THE DEVICE INSTRUCTIONS FOR USE (IFU) AS A RESULT OF THIS COMPLAINT AT RWMIC. IFU NUMBER: IFU GA-E074 EN US. OLD REVISION NO.: INDEX: 2012-01 V1.0 / ECO 2011-0351. NEW REVISION NO.: V2.0 / 2022-04 / PK22-0448. IFU RELEASED DATE: 12-JULY-2022. IN GENERAL, THE USER IS ADVISED IN THE ASSOCIATED INSTRUCTIONS FOR USE GA-E074 EN US UNDER CHAPTER 9 (REPROCESSING AND MAINTENANCE) THAT A VISUAL AND FUNCTIONAL CHECK MUST BE CARRIED OUT BEFORE AND AFTER EACH USE, AS WELL AS DURING REPROCESSING. NOTICE: (IMPORTANT). OBSERVE THE FOLLOWING WHEN CLEANING THE PRODUCTS: - PRODUCTS WITH LONG CHANNELS: PULL THROUGH THE CLEANING BRUSH. INSERT THE CLEANING BRUSH INTO THE CHANNEL WITH THE BRUSHLESS SIDE FIRST AND PULL OUT THE BRUSH ON THE OTHER SIDE OF THE CHANNEL. - OTHER PRODUCTS/PARTS: USE A BRUSH PASS MOVE THE CLEANING BRUSH FORWARDS AND BACKWARDS ONCE. SPECIFICALLY, SECTION 9.1, DESCRIBES FULLY THE REPROCESSING SEQUENCES FOR MANUAL AND MACHINE CLEANING (IN W/D) PROCESSES. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) CONSIDERS THIS MDR CLOSED. RWMIC WILL SUBMIT A FOLLOW UP REPORT IF NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    RWMIC REFERENCE COMPLAINT NO. (B)(4). THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE FOLLOWING NEW INFORMATIONS: (SEE H10) - RESULTS OF THE DEVICE PRODUCT HISTORY EVALUATION - UPDATE/REVISION OF THE ASSOCIATED DEVICE INSTRUCTIONS FOR USE: IFU GA-E074 ALSO, PLEASE SEE RELATED MDR'S 1418479-2021-00013 AND 1418479-2021-00014. RWMIC MDR AWARENESS DATE: 15-MAR-2021.

    Additional Manufacturer Narrative · 1

    (B)(4). RWMIC CONSIDERS THIS MDR/COMPLAINT OPEN. RWMIC WILL SUBMIT A FOLLOW UP REPORT AFTER REVIEWING THE IFU, FOLLOWING UP WITH THE MANUFACTURER AND/OR NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON MARCH 15, RICHARD WOLF MIC RECEIVED MEDWATCH REPORT MW5099373 WITH THE FOLLOWING EVENT DESCRIPTION: THE MANUFACTURER'S INSTRUCTIONS FOR USE (IFU) IS INADEQUATE. THE DEVICE IS UNABLE TO BE THOROUGHLY CLEANED. RESIDUAL BIOBURDEN IS FOUND IN THE SHAFT OF THE PROBE AND INSIDE THE CONE. THE MANUFACTURER/MODEL NUMBERS ARE AS FOLLOWS: RICHARD WOLF: INTRAUTERINE PROBE - 8378. 00, SMALL CONE - 8378. 90, LARGE CONE - 8378. 91. BOROSCOPE INSPECTION REVEALED WHAT APPEARED TO BE BIOFILM COLONIES. PLEASE ALSO SEE MDR 1418479-2021-00014 AND 1418479-2021-00013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567674 NA INTRAUTERINE PROBE Ø 32MM WL 32MM HHI RICHARD WOLF GMBH 8378.00 04055207040003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown