MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW PLUS HD; DISCOSCOPE 20° Ø 9.3MM SL 177MM

Model Number	892109205
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure, the image on the scope became blurry, making visualization unclear.Due to it, the procedure was prolonged by an hour.As the procedure was almost completed, the doctor decided not to convert it to another method.After the procedure, the scope was inspected and found that it has water leakage.It was reported that the scope has been used multiple times.The procedure was completed without patient harm.
Additional Manufacturer Narrative
The investigation is still on-going.

• Brand Name: PANOVIEW PLUS HD
• Common Device Name: DISCOSCOPE 20° Ø 9.3MM SL 177MM
• 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: valentin felsing ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 25164754
• Report Number: 9611102-2026-00019
• Device Sequence Number: 10182637
• Product Code: HRX
• UDI-Device Identifier: 04055207035115
• UDI-Public: 04055207035115
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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: 892109205
• Device Catalogue Number: 892109205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2025
• 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