MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW; MORCESCOPE 12° 24.5FR WL 199MM

Model Number	8970402
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although a delay was reported, there is no report of injury, and the planned treatment was able to be completed with a back-up device without unacceptable risk to the patient.Richard wolf gmbh (rw gmbh) considers this case to be a reportable malfunction.
Event or Problem Description
It was reported that during the laser enucleation of the prostate (holep) of the patient, the doctor had difficulty in getting tissue in part of the bladder neck of the scope.He was wrenching hard around the prostate and still could not reach it, so he pulled out the scope and discovered it was bent.There is no report of injury, however, there is a report of a 30-minute delay while waiting for the 2nd set of equipment.The doctor proceeded to performed perineal urethrostomy (pu) to create a channel for better access and then continued with the backup wolf scope and sheaths.

• Brand Name: PANOVIEW
• Common Device Name: MORCESCOPE 12° 24.5FR WL 199MM
• 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: 23017140
• Report Number: 9611102-2025-00048
• Device Sequence Number: 9665336
• Product Code: FJL
• UDI-Device Identifier: 04055207023525
• UDI-Public: 04055207023525
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K041610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 8970402
• Device Catalogue Number: 8970402
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2024
• 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: INNER SHEATH RESECTOSCOPE,TYPE 8655.3841:SN1550302; OUTER SHEATH RESECTOSCOPE, TYPE 8655.374
• Patient Sex: Unknown