MAUDE Adverse Event Report: RICHARD WOLF GMBH PRINCESS; INNER SHEATH RESECTOSCOPE 19FR

Model Number	8653018
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the plastic tip of the inner sheath, type 8653.018, broke off during procedure (holmium laser enucleation of the prostate (holep)).The broken pieces were successfully retrieved.
Additional Manufacturer Narrative
There is no report of injury to the patient or other personnel.However, the reported issue caused a minimal delay in the procedure while surgeon was looking for the missing piece.They were able to retrieve the piece.The delay did not put the patient at unacceptable risk.There was no additional treatment or procedure needed, and the scheduled procedure was completed.Over the past two years, richard wolf gmbh has reported cases of serious injury with a similar fault pattern.Based on the information available and the fact that this issue did not put the patient at risk, richard wolf gmbh consider this case to be a reportable malfunction.
Additional Manufacturer Narrative
Investigation results: the inner sheath resectoscope 19fr, model 8653.018 was investigated and the reported condition was confirmed.The ceramic tip has broken off just below the lip of the metal sheath tube.Probable root cause: the probable root cause was determined to be user error.The damage to the tip is consistent with a hard strike of excessive force against a solid surface.When a ceramic tip breaks below the metal lip, it often remains in place from the small bit of adhesive left on the broken part and does not fall off until used.Manufacturing analysis: the inner sheath resectoscope 19fr, model 8653.018, with lot number 1562945, was manufactured on november 14, 2023.The lot size is 20 units; no special approvals or nonconformities were noted.Historical data analysis: on 13th february 2024, 3 pieces were delivered to richard wolf medical instruments corp.(rwmic) as well on 21st march 2024, 14 pieces were delivered to rwmic.On 31st january 2025 fairview ummc riverside hospital received one inner sheath resectoscope.Since the delivery up to this day, no other complaints have been reported about this batch number.To date, there have been no other complaints regarding this batch number, either from fairview ummc riverside hospital or from other customers.Risk analysis: in general, chapter 8 of instruction for use (ifu) ga-d349 / en / us / v7.0 / 2023-07 / pk23-0191 instructs the user to perform a visual and functional inspection before and after each use.Furthermore, chapter 9 recommends that the user observe the following warning: the products have limited strength! applying excessive force will cause damage, impair function, and thereby endanger the patient.Do not use the products if they are damaged, incomplete, or have loose parts.Ensure that no missing parts remain inside the patient.Inspect the products immediately before and after each use for damage, loose parts, and completeness.Potential functional impairments can be easily identified if these instructions are followed.In our risk analysis d3 rev.V00, manufacturing, handling, and design-related hazards regarding functional impairment, as well as risks arising from a non-functional product, were considered in terms of the corresponding extent of damage and the assumed probability of occurrence and were assessed as an acceptable risk.

• Brand Name: PRINCESS
• Common Device Name: INNER SHEATH RESECTOSCOPE 19FR
• 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: 24400834
• Report Number: 9611102-2026-00005
• Device Sequence Number: 9859062
• Product Code: FDC
• UDI-Device Identifier: 04055207042861
• UDI-Public: 04055207042861
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K062720
• 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,Followup
• Report Date (Section B): 03/30/2026

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: 8653018
• Device Catalogue Number: 8653.018
• Device Lot Number: 1562945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2023
• 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
• Patient Sex: Unknown