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.
Additional Manufacturer Narrative
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.

• 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: marco bruxmeier ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 17287043
• Report Number: 9611102-2023-00044
• Device Sequence Number: 20497633
• Product Code: HIH
• UDI-Device Identifier: 04055207023686
• UDI-Public: 04055207023686
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,Followup
• Report Date (Section B): 08/09/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown