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

Model Number	892109205
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a planned full endoscopic stenosis decompression (two levels) procedure, the working channel is "partially blocked".Kerrison rongeur (punches) and high-speed burr cannot pass through the channel.Although, no foreign body was blocking the channel, it was found that the working channel was triangularly shaped.The surgeon had to change the surgical procedure to a minor surgery and use a microscope in the end.
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: 25046940
• Report Number: 9611102-2026-00016
• Device Sequence Number: 13206796
• Product Code: HRX
• UDI-Device Identifier: 04055207035115
• UDI-Public: 04055207035115
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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