BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMBA VISION

    MDR report key: 12771606 · Received November 8, 2021

    Report

    Report Number
    1418479-2021-00049
    Event Type
    Malfunction
    Date Received
    November 8, 2021
    Date of Event
    October 19, 2021
    Report Date
    December 15, 2021
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FAJ
    UDI-DI
    04055207063460
    PMA / PMN Number
    K051176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). RWMIC CONSIDERS THIS MDR OPEN. RWMIC WILL SUBMIT A FOLLOW UP REPORT AFTER THE DEVICE EVALUATION/CUSTOMER CONTACT HAS BEEN COMPLETED AND/OR NEW INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF GMBH. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION IS THE IMPORTER OF THIS DEVICE. FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH MISSING INFORMATION, NEW INFORMATION, AND CHANGED INFORMATION. MISSING INFORMATION: USER FACILITY, THREE ATTEMPTS WERE MADE DIRECTLY TO USER FACILITY, ONE ATTEMPT THROUGH THE SALES REP IN AN EFFORT TO COLLECT PATIENT AND USER INFORMATION. AS OF 12/15/2021,THE ONLY INFORMATION RECEIVED FROM THE USER FACILITY WAS TO CORRECT MISINFORMATION ABOUT THE PROCEDURE. NEW INFORMATION: THE FOLLOWING FIELDS HAVE NEW INFORMATION: B5, G2-3, G6, H2, H6, H10. CHANGED INFORMATION: THE FOLLOWING FIELDS HAVE CHANGED INFORMATION: H3. RWMIC CONSIDERS THIS MDR CLOSED. SHOULD RWMIC RECEIVE NEW INFORMATION (USER FACILITY RESPOND TO INQUIRY) A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO RICHARD WOLF: THE DEVICE WAS DELIVERED TO THE CUSTOMER ON (B)(6) 2021. THE FIRST TIME IT WAS USED THE PICTURE ON THE MONITOR WOULD FLICKER AND THEN EVENTUALLY SHUT OFF. THE SCOPE WAS WORKING WELL FOR THE FIRST FEW MINUTES AND THEN THE ISSUES STARTED HAPPENING. ADDITIONAL DETAILS: 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? UNKNOWN. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? NO. WAS THE SCHEDULED PROCEDURE COMPLETED? NO. THE FOLLOWING QUESTIONS WERE ASKED OF AND ANSWERED BY THE SALES REP REGARDING THE DELAY IN THE PROCEDURE: . HOW LONG WAS THE DELAY? LONG ENOUGH FOR THEM TO ABORT THE PROCEDURE. WHAT ACTIONS WERE BEING DONE DURING THE DELAY? THEY PULLED OUT THE PADDLE AND CLEANED IT AND RE INSERTED IT. DID THE PATIENT REQUIRE ANY ADDITIONAL TREATMENT DURING THE DELAY OR WILL REQUIRE ANOTHER PROCEDURES AS THE RESULT OF THE DELAY? THE PATIENT WILL REQUIRE ANOTHER APPOINTMENT TO FINISH THE PROCEDURE. WHAT WAS THE PATIENT'S OUTCOME? THE PROCEDURE WAS NOT FINISHED.

    Description of Event or Problem · 0

    THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE INVESTIGATION AND THE RESPONSE FROM THE USER FACILITY. DEVICE EVALUATION: THE DEVICE WAS EVALUATED USING VISUAL AND FUNCTIONAL MEANS. THE REPORTED CONDITION, FLICKERING PICTURE THEN SHUTOFF, WAS CONFIRMED. FINDINGS: NO IMAGE, ELECTRONIC UNIT WITHIN THE DEVICE IS NOT FUNCTIONAL. UNABLE TO DETERMINE WHY THE COMPONENT IS NOT WORKING. WHEN ELECTRONIC UNIT IS EXCHANGED, THE IMAGE APPEARS. THE DEVICE WAS REPAIRED, THE SHAFT AND SENOR WERE REPLACED. RESPONSE FROM THE USER FACILITY: WE RECEIVED A CORRECTION FROM THE USER FACILITY ON THE PROCEDURE. WE HAD PREVIOUSLY BEEN TOLD, BY THE SALES REP, THAT THE PROCEDURE HAD TO BE ABORTED. ACCORDING TO THE USER FACILITY, "THE PROCEDURE WASN'T ABORTED, THE PROVIDER WAS ABORTED FOR THAT PATIENT, PROVIDER WAS ABLE TO CONTINUE WITH A DIFFERENT SCOPE." NO OTHER INFORMATION WAS PROVIDED. THE MEDWATCH QUESTIONNAIRE THAT WAS ATTACHED TO THE EMAIL WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1662922 MAMBA VISION SENSOR-CYSTOSCOPE 16.2FR WL 400MM FLEXIBLE FAJ RICHARD WOLF GMBH 7315001 04055207063460

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown