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	04/30/2024
Type of Reportable Event	Malfunction
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, every time the scope is used, it gets foggy and the image is poor.When the hysteroscope is inserted into the patient, the lens became cloudy immediately at the beginning of the procedure.Preventing adequate visualization of the diagnostic and operative field.It appears moisture condenses on the inner side of the lens.The entire procedure was completed with a back-up device.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
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: valentin felsing ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 19452486
• Report Number: 9611102-2024-00021
• Device Sequence Number: 20968663
• Product Code: HIH
• UDI-Device Identifier: 04055207023686
• UDI-Public: 04055207023686
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K880314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 8986402
• Device Catalogue Number: 8986402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown