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

Model Number	8675324
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The internal sheath resectoscope 24fr, type 8675324, was examined by the specialist department upon receipt.Apart from the damage, the inner shafts show normal signs of wear and tear and are only slightly bent.Assessment: the product was subjected to repeated mechanical stress during laser enucleation of the prostate.Thermal influences due to laser applications or hf current are not apparent.On both shafts, the shaft tube broke during use at the connecting bridges between the slit openings, proximally in the housing.In principle, the products in question are shaft components of a continuous flush double shaft system, i.E., the inner shaft must always be used in combination with an outer shaft.The combination with the outer shaft provides additional stability to the shaft system.It can be safely assumed that the damage begins due to frequent, cyclical stress on one or at most two bars (presumably due to compression / buckling / stretching).Only after progressive and probably complete damage to these initially affected bars will the third section then presumably break into a violent fracture.Previous tests have shown that high forces in combination with low load cycles (n<50) cannot reproduce the damage pattern reported in the complaint in any way.These loads always lead to deformation/damage at other points.These tests also demonstrate the mechanical stabilization of the inner shaft by the outer shaft and the enormous deformation of the shafts without visible damage to the affected area.The inner shaft for the resectoscope, type 8675324, was manufactured on october 13, 2023, under batch number 1560190.The order size was (b)(4) pieces, and no abnormalities or special approvals were noted or made.The affected product 8675324 has been sold (b)(4) times in the last 5 years.The evaluation of the complaint database did not reveal any comparable reportable incidents.The instructions for use ga-d366 / en / eu / v1.0 / 2020-12 / contain the following applicable warnings and safety instructions: 9 checks warning: injuries due to damaged or incomplete products! injuries to the patient, user, and third parties are possible.Do not use products that are damaged, incomplete, or have loose parts.Caution: send damaged or incomplete products with loose parts in for repair.Repairs may only be carried out by authorized specialists.Carry out checks before and after each use.9.1 visual inspection: · check the products and accessories for: · damage · sharp edges · loose or missing parts · rough surfaces.10 use.Limited stability of the products! excessive force will cause damage, impair function, and endanger the patient.Do not use products that are damaged, incomplete, or have loose parts.No missing parts may remain in the patient.Check the products for damage, loose parts, and completeness immediately before and after use.10.1 preparation / commissioning.The following preparatory measures must be carried out for the respective "shark" resectoscopes: 1.Check assembly: see chapter 11.4 reprocessing procedure - shaft-irrigation attachment-connecting part 2.Perform check: see chapter 9 checks 10.1.1 insert inner shaft (1) into outer shaft (2) "shark" resectoscope, rotatable lock: 1.Check that o-rings (1.3) (1.5) are mounted on the inner shaft (1).2.Insert the inner shaft (1) into the outer shaft (2) until it stops.The outer shaft (2) automatically locks into place (audible) in the inner shaft (1) by means of a ball lock (2.5).3.Check that the rotatable connection is seated correctly.11 preparation and maintenance damage to the products due to the use of non-approved preparation methods.Summary: the technical analysis carried out was unable to determine a clear cause.The product examined shows signs of age and wear that are within the expected range.However, it is possible that their combination and severity contributed to the damage.The investigation results show that the shaft broke off proximally at the locking rotary part due to mechanical overload.Spontaneous overloading by the user or singular effects during use, reprocessing, or improper handling can neither be proven nor ruled out and therefore remain as possible causes.Rough handling of the product cannot be ruled out either.In this context, careful handling is expressly recommended.Since no specific technical cause could be identified, a direct comparison with specific risks from the risk file is not useful.However, the hazardous situations documented there are generally covered.Possible risks such as "malfunction/loss of function" are listed in the risk management file d3: reusable shafts, tubes, v00.The overall probability of this problem occurring corresponds to the previously defined values, and the overall risk of the device remains in the acceptable category.
Event or Problem Description
It was reported that during a laser enucleation of the prostate, the inner shaft broke off.The operation was completed without harm to the patient and without delay.

• 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: valentin felsing ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 22541806
• Report Number: 9611102-2025-00034
• Device Sequence Number: 15203845
• Product Code: FJL
• UDI-Device Identifier: 04055207019658
• UDI-Public: 04055207019658
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 07/18/2025

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
• Device Model Number: 8675324
• Device Catalogue Number: 8675324
• Device Lot Number: 1560190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown