MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW PLUS HD; DISCOSCOPE 25° Ø 6.9MM SL 207MM

Model Number	892101254
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During the examination of the discoscope, it was determined that the frame of the distal optical component had shifted slightly forward, causing the optics to leak at this point and all optical components to become stained.As there are no signs of improper use or handling by the customer, it is unclear how this incident occurred.The inspection of the optics did not reveal any systematic defects from a manufacturing or design perspective.Based on the results described above, the root cause is assumed to be a sporadic failure.Corrective measures are not being considered based on the test results.During the assessment period, there have been two comparable complaints to date; therefore, no general product or manufacturing problem is apparent.In general, the user is advised in the corresponding operating instructions ga-b223 in chapter 9 that a visual and functional check must be carried out before and after each use.Possible damage of the above type can normally be detected without any problems if these instructions are followed.In our risk analysis a1-1: reusable rigid optics, v01, manufacturing-related, handling-related, and design-related hazards with regard to functional impairment as well as risks due to an unusable product with the corresponding extent of damage and the assumed probability of occurrence were considered and assessed as an acceptable risk.As the investigation of the current complaint did not reveal any new risks, the risk assessment remains valid in view of the facts described.
Event or Problem Description
It was reported that during the surgical procedure, the light beam from the endoscope comes out, but nothing is visible in the endoscope eyepiece.The doctor tried to adjust the white balance as usual, however, the image was very dark or not visible at all.Due to endoscope's poor-quality image, the surgical procedure was cancelled.The patient was not harmed or injured during the procedure.

• Brand Name: PANOVIEW PLUS HD
• Common Device Name: DISCOSCOPE 25° Ø 6.9MM SL 207MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: anja ehrenfeuchter ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 23839884
• Report Number: 9611102-2025-00062
• Device Sequence Number: 9816720
• Product Code: HRX
• UDI-Device Identifier: 04055207035054
• UDI-Public: 04055207035054
• Combination Product (Y/N): N
• Initial Reporter Country: UP
• PMA/510(K) Number: K000046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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?: No
• Operator of Device: Other
• Device Model Number: 892101254
• Device Catalogue Number: 89210.1254
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown