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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the endoscopic enucleation of a prostatic adenoma, once the resectoscope was inserted through the vesical neck, the distal portion of the urethral membrane in ceramic was detached.There was a brief interruption in the procedure for the removal of the distal detachment which was extracted with difficulty by endoscopic forceps." according to the user, the broken piece was completely removed, and the procedure could be completed without any clinically relevant delay in surgery.The medical purpose of the application was fulfilled and there was no danger for the patient, the user or third parties.
Additional Manufacturer Narrative
Since there have been similar cases reported as "serious injury" in the last 2 years, richard wolf considers this case to be a reportable malfunction.
Additional Manufacturer Narrative
The inner sheath was sent to richard wolf for examination.On the distal side, the insulation insert made of a ceramic material has broken off.The production order for inner sheath resectoscope 24fr, 8675324, batch 1289356 consists of 25 sheaths.Two sheaths out of this batch were sold to our distributor in italy on october 13, 2015.As of april 7, 2025, no further complaints had been received about the interior shaft for resectoscope 24f from batch 1289356.Possible hazards were considered in the risk assessment d3 v.00 (reusable sheaths, tubes) with the corresponding extent of damage and probability of occurrence.Ceramic is a hard and therefore brittle material and can break abruptly when subjected to excessive external forces.However, it is very unlikely that a tip without prior damage will break off during use.Most likely, prior damage occurred during reprocessing, but in principle it is possible at many points before or after use.Inappropriate handling, e.G.Dropping, impact, shock or similar mechanical stresses can lead to hairline cracks and/or ceramic chipping in the distal area of the resectoscope sheath, as described in the instructions for use, ga-d366 / it / eu / v1.0 / 2020-12 /.During a subsequent use, smaller forces are then sufficient to completely damage the ceramic, as was most likely the case here.The instructions for use instruct the user to pay attention to surface changes and safe handling and not to use damaged resectoscope sheaths and to send them for repair.In this case, improper handling is indicated.Missing parts are expected to be discovered before completion of the procedure, under close personal supervision of the patient during a procedure.Therefore, the probability that the reported problem will result in death, life-threatening injury, or permanent impairment of body structure is low.The defects identified do not describe a general product problem that involves non-conformity, an adverse trend, or previously unrecognized hazards.Since the complaint relates to a handling error, a systemic problem is not apparent and the warnings in the operating instructions are considered sufficient for the problem described by the customer, no further action will be taken in relation to this incident, except to monitor further cases to determine a possible trend.

• 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: anja ehrenfeuchter ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 21644464
• Report Number: 9611102-2025-00014
• Device Sequence Number: 20726411
• Product Code: FJL
• UDI-Device Identifier: 04055207019658
• UDI-Public: 04055207019658
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2025

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: 1289356
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2015
• 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