MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW; TELESCOPE 30° Ø 4MM WL 300MM

Model Number	8654422
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Air Embolism (1697); Cardiac Arrest (1762); Hyperventilation (1910); Electrolyte Imbalance (2196); Brain Injury (2219)
Date of Event	07/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Preliminary root cause analysis: in our opinion, it is highly unlikely that the endoscope alone could have caused air embolism.As we do not have the telescope available for examination and, despite repeated requests, have not received any further information from the user regarding the procedure, the instrument set used, the type of irrigation with purisole or nacl (sodium chloride), the duration of use, complications, etc.Currently, it is not possible to comment on the cause.
Event or Problem Description
It was reported that, during a prostate resection procedure using a bipolar resectoscope and an erbe vio 300d generator, the surgeon observed a strong electrolytic reaction at the beginning of the procedure.The patient suffered sudden hypocapnia, severe gas embolism, and three cardiac arrests.The patient is currently in intensive care with severe brain damage.

• Brand Name: PANOVIEW
• Common Device Name: TELESCOPE 30° Ø 4MM WL 300MM
• 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: 22839667
• Report Number: 9611102-2025-00044
• Device Sequence Number: 4926687
• Product Code: GCM
• UDI-Device Identifier: 04055207018798
• UDI-Public: 04055207018798
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K993103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2025

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: 8654422
• Device Catalogue Number: 8654.422
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ERBE VIO 300D GENERATOR
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown