BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANOVIEW PLUS

    MDR report key: 17287043 · Received July 10, 2023

    Report

    Report Number
    9611102-2023-00044
    Event Type
    Injury
    Date Received
    July 10, 2023
    Date of Event
    June 16, 2023
    Report Date
    August 9, 2023
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    HIH
    UDI-DI
    04055207023686
    PMA / PMN Number
    K880314
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE NEW INFORMATION: H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS). THE HYSTEROSCOPE 30° Ø 3.9MM WL 217MM, PART ID: 8986402, SERIAL#: (B)(6) WAS INVESTIGATED AT RWMIC. THE INVESTIGATIONS REVEALED THAT THE SCOPE WAS RECEIVED WITH A CLOUDY IMAGE. THERE WAS A PRESENCE OF MOISTURE INSIDE THE OPTIC SYSTEM. FURTHER INVESTIGATIONS SHOWED THAT THE SCOPE LEAKS THROUGH THE FIBERS. THE NEGATIVE LENS WAS CHIPPED AND THE DISTAL TIP HOUSING HAS A SMALL DENT. THE DAMAGE TO THE SCOPE WAS LIKELY CAUSED DUE TO AN EXTERNAL FORCE EXERTED DURING A PROCESS. THEREFORE, USER ERROR HAS BEEN DETERMINED AS THE ROOT CAUSE. THE REPORTED HYSTEROSCOPE 30° Ø 3.9MM WL 217MM, PART ID: 8986402, SERIAL#: (B)(6) WAS PRODUCED ON 22/MAY/2018. NO ANOMALIES WERE DETECTED DURING PRODUCTION. RW GMBH HAS A TOTAL OF 58 SIMILAR COMPLAINTS "BLURRY/FOGGY/CLOUDY IMAGE" INCLUDING THE CURRENT ONE REGARDING HYSTEROSCOPE 30° Ø 3.9MM WL 217MM, PART ID: 8986402 RECEIVED DURING THE REVIEW PERIOD FROM 01/JAN/2018 TO 06/APR/2023. IN GENERAL, THE USER IS ADVISED IN THE ASSOCIATED INSTRUCTIONS FOR USE GA-E 200 / EN / INDEX: 2019-03 V8.0 / PK18-9399 UNDER CHAPTER 7 THAT A VISUAL AND FUNCTIONAL CHECK MUST BE CARRIED OUT BEFORE AND AFTER EACH USE. POSSIBLE FUNCTIONAL IMPAIRMENTS OF THE ABOVE TYPE CAN BE DETECTED BY THE USER PRIOR USAGE IF THESE INSTRUCTIONS ARE FOLLOWED. IN OUR RISK ANALYSIS B1-2 REV.05, MANUFACTURING-RELATED, HANDLING-RELATED, DESIGN-RELATED AND ENVIRONMENT-RELATED HAZARDS, WITH REGARD TO A FUNCTIONAL IMPAIRMENT, AS WELL AS RISKS DUE TO A PRODUCT THAT CANNOT BE USED, THE OVERALL PROBABILITY OF OCCURRENCE FOR THIS ISSUE IS CONSISTENT WITH PREVIOUSLY DEFINED LEVELS AND OVERALL RISK OF THE DEVICE REMAINS IN THE ACCEPTABLE CATEGORY.

    Description of Event or Problem · 0

    THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A HYSTEROSCOPE 30° Ø 3.9MM WL 217MM, PART ID: 8986402, SERIAL # (B)(6). ACCORDING TO THE USER FACILITY, "THE FIRST HYSTEROSCOPE WAS CLEAR AND THE FIBEROPTICS LOOK GOOD. WHEN INSERTED INTO THE PATIENT AND TURNED ON THE WATER FLOW, THE VISUAL FIELD BECAME FOGGY. THE PROVIDER TRIED TO USE A SECOND SCOPE AND HAD THE SAME ISSUE. THE PROCEDURE WAS COMPLETED WITH THE SECOND HYSTEROSCOPE AS THE VISUAL FIELD WAS NOT AS IMPAIRED AS IN THE FIRST SCOPE." IN ADDITION, THE REPORTED ISSUE CAUSED A 30 MINUTE DELAY DURING A DIAGNOSTIC HYSTEROSCOPY PROCEDURE WHILE TRYING TO RESOLVE THE ISSUE WITH THE SCOPE, RETRIEVE THE BACK-UP DEVICE, AND TRY TO RESOLVE THE SAME ISSUE WITH THE BACK-UP SCOPE. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184856 PANOVIEW PLUS HYSTEROSCOPE 30° Ø 3.9MM WL 217MM HIH RICHARD WOLF GMBH 8986402 04055207023686

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other