MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK; INTERNAL SHEATH RESECTOSCOPE 24FR

Model Number	8675324
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the ureteroscopy with tumor ablation, the ceramic tip broke off inside the patient's bladder.The reported issue caused an hour delay in the procedure while troubleshooting how to retrieve the piece out of the patient.The physician used a laser and stone basket to remove the fragments.The delay did not cause any injuries or unacceptable clinical risks to the patient or other personnel, and the scheduled procedure was successfully completed.
Additional Manufacturer Narrative
Investigation results: the sheath resectoscope was examined in the specialist department, and the following were found: - ceramic tip is broken along a smooth curve.- several large dents are present along the length of the shaft.- the o-rings are worn.Causes: the determined root cause of the reported issue is user error.The ceramic tip was damaged by excessive force creating a crack within the tip; futher evidence of excessive force is demonstrated by the abundant dents along the shaft.Once the crack had developed it broke during operation.Section 8.1.2 of instruction for use, ga-d366-us / en / 2017-02 v4.0 warns of the potential damage to the tip of the scope from mechanical loads and the possibility of hair cracks and/or spalling resulting in the ceramic.Also detailed in section 8.1.2 is the requirement to check the cermaic insulation for damage prior to each use.Manufacturing analysis: the internal sheath resectoscope 24fr, 8675324, lot 1452559 was manufactured on 25 may 2020.The batch consisted of 25 pieces.No issue was identified during production.No further complaints were received from the reported batch.Historical data analysis: two serious injuries with a similar error pattern have been reported in the past 2 years.As the review of all available data does not show signs of systematic errors or a trend, no further action is necessary.Risk analysis: the subject issue of "parts loss/product parts fall into the patient" is present in the risk management file d3: reusable shafts, tubes, voo.The overall probability of occurrence for this issue remains at previously defined levels and overall risk of the device remains in the acceptable category.The risk profile remains unchanged.

• Brand Name: SHARK
• Common Device Name: INTERNAL SHEATH RESECTOSCOPE 24FR
• 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: vatceslav gerdt ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 22330542
• Report Number: 9611102-2025-00025
• Device Sequence Number: 15556188
• Product Code: FJL
• UDI-Device Identifier: 04055207019658
• UDI-Public: 04055207019658
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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: 8675324
• Device Catalogue Number: 8675324
• Device Lot Number: 1452559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2020
• 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
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 26 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White