BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANOVIEW PLUS DISKOSKOP

    MDR report key: 15017887 · Received July 14, 2022

    Report

    Report Number
    9611102-2022-00032
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    June 21, 2022
    Report Date
    December 15, 2022
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    HRX
    UDI-DI
    04055207035078
    PMA / PMN Number
    K000046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF THE MANUFACTURER RICHARD WOLF GMBH. RW GMBH CONSIDERS THIS MDR OPEN. RW GMBH WILL SUBMIT A FOLLOW UP REPORT AFTER THE DEVICE EVALUATION HAS BEEN COMPLETED AND/OR NEW INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH THE RESULTS OF THE DEVICE INVESTIGATION AS WELL AS DUE DILIGENCE FOR PATIENT INFORMATION. THE FOLLOWING FIELDS HAVE NEW INFORMATION: B4, B5, D9, G3, G6, H2, H3, H4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), AND H10. RESULTS OF DUE DILIGENCE FOR PATIENT INFORMATION: THE USER FACILITY WAS CONTACTED SEVERAL TIMES IN AN EFFORT TO COLLECT PATIENT INFORMATION. AS OF 14-DEC-2022, RWMIC HAS NOT RECEIVED ANY RESPONSE. DATES OF USER FACILITY CONTACT: 1ST ATTEMPT: 07/06/2022 VIA EMAIL: NO RESPONSE 2ND ATTEMPT 08/12/2022 VIA EMAIL: NO RESPONSE 3RD ATTEMPT: 09/02/2022 VIA EMAIL: NO RESPONSE RESULTS OF DEVICE INVESTIGATION: (RWGMBH INVESTIGATION REPORT DEVICE EVALUATION, FORM 5020 (13), DATED: 12/13/2022) REPORTED CONDITION FINDINGS: ACCORDING TO THE FINDINGS, THE SHEATH TUBE IS BENT AND DENTED IN SOME SPOTS. THE OPTICAL FIBER IS CHEMICALLY THERMALLY DAMAGED. DUE TO FALL DAMAGE, THE EYEPIECE FUNNEL IS FLAKED OFF. THE IMAGE SHARPNESS IS MISALIGNED AND THE OPTICAL SYSTEM IS HEAVILY SOILED. ADDITIONAL FINDINGS: THE DEVICE HAS AN OLD DESIGN. THERE IS NO SPARE PART FOR THE CURRENT SHEATH TUBE. PROBABLE ROOT CAUSE RATIONALE: THE MANUFACTURE DATE OF THE DEVICE IS 09/23/2014. THE DEVICE WAS DELIVERED TO THE USER FROM RWMIC ON 03/05/2022 AFTER THE LAST REPAIR. ACCORDING TO THE FINDINGS, THE PROBABLE ROOT CAUSE IS USER ERROR/ REPROCESSING ERROR. THE USER IS ADVISED IN THE RELEVANT IFU GA-B223 I USA/ 2012--10 V5.O / ECO 2012-0519 IN SECTION 7 CHECKS ABOUT THE VISUAL AND FUNCTIONAL CHECK OF THE DEVICE BEFORE AND AFTER EACH USE. FURTHERMORE, THERE ARE SAFETY NOTICES IN SECTION 6, USE ABOUT THE LIMITED STRENGTH OF THE DEVICE AS WELL AS IN SECTION 6.2.3 IMAGE QUALITY, ABOUT A POTENTIAL RISK FOR THE PATIENT IF THE IMAGE IS BLURRED. RECOMMENDED PRODUCT DISPOSITION: THE DEVICE WILL BE SCRAP. THE CUSTOMER WILL BE OFFERED A CURRENT MODEL OF THE DEVICE AS REPLACEMENT.

    Description of Event or Problem · 0

    RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) REFERENCE COMPLAINT (B)(4). IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) THAT "THIS T&E (TRIAL & EVALUATION) SCOPE WAS IN USE AT LONE PEAK SURGERY CENTER LOCATED IN DRAPER, UT. THE SCOPE WHEN DARK DURING A TWO-LEVEL INTERLAMINAR PROCEDURE. ONE LEVEL WAS COMPLETED AND ONE LEVEL WAS NOT COMPLETED." ADDITIONAL INFORMATION REPORTED BY THE INITIAL REPORTER: 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? YES. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? NO. WAS THE SCHEDULED PROCEDURE COMPLETED? NO. ADDITIONAL DETAILS ABOUT THE ADVERSE EVENT; 06-JULY-2022. THERE IS NO REPORT OF INJURY TO THE PATIENT OR ANY OTHER PERSONNEL AS A RESULT OF THE REPORTED ISSUE. THERE WAS A REPORT OF A DELAY IN THE PROCEDURE THAT PUT THE PATIENT AT RISK. THERE WAS NO BACK-UP DEVICE AVAILABLE AND THE SCHEDULED PROCEDURE WAS ABORTED RESULTING IN AN INCOMPLETE SURGERY. THE PATIENT'S OUTCOME WAS POOR AS THE IMMEDIATE POST-OP WAS SUBOPTIMAL AND NOT AN EXPECTED OUTCOME. THE COMPLETION OF THE PROCEDURE IS PENDING A REPEAT MRI. RWMIC MDR AWARENESS DATE: 21-JUNE-2022.

    Description of Event or Problem · 0

    RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) REFERENCE COMPLAINT (B)(4). THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE EVALUATION AND DUE DILIGENCE FOR PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451940 PANOVIEW PLUS DISKOSKOP DISCOSCOPE 25° Ø 6.9MM SL 165MM, HRX RICHARD WOLF GMBH 89210.3254 04055207035078

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O