MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW PLUS; HYSTEROSCOPE 30° Ø 3.9MM WL 217MM

Model Number	8986402
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: PANOVIEW PLUS
• Common Device Name: HYSTEROSCOPE 30° Ø 3.9MM WL 217MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• MDR Report Key: 17286914
• Report Number: 1418479-2023-00017
• Device Sequence Number: 3011249
• Product Code: HIH
• UDI-Device Identifier: 04055207023686
• UDI-Public: 04055207023686
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2023
• Report Date (Section F): 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8986402
• Device Catalogue Number: 8986402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/19/2023
• Device Age: 5 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/10/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/10/2023