MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK; INTERNAL SHEATH RESECTOSCOPE 22FR

Model Number	8675322
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the information received, the tip broke off during procedure.The doctor confirmed that no pieces were in the bladder.There is no report of injury to the patient or other personnel.
Additional Manufacturer Narrative
The available information indicate that the reported issue did occur during the end of the procedure, but there was no injury or illness to the patient or other personnel.No pieces remained in the bladder, and the scheduled procedure was completed without delay and unacceptable risk.Also, no additional medical treatment or procedure was required.Over the past two years, richard wolf gmbh has reported three cases of serious injury with a similar fault pattern.In this regard, the current case is being reported as a reportable malfunction.
Additional Manufacturer Narrative
Investigation results: the inner sheath resectoscope was sent to richard wolf for examination.The ceramic tip was found broken.Also found there were multiple small dents along shaft.Cause: the probable root cause was determined to be user error.The damage broken tip, alongside the various dents, suggests rough handling over a prolonged period of time.Rough handling an excessive force to the sheath led to multiple cracks in the ceramic tip (supported by the irregular shape of the breakage), ultimately resulting in the reported issue.Per ga-d366-us / en / 2017-02 v4.0 section 8.1.2, the sheath must be checked for damage prior to use prior to use.Manufacturing analysis: the internal sheath resectoscope 22fr type 8675322 with batch number 1500752 was manufactured on december 16, 2021.The batch contains (b)(4) units, and no abnormalities were detected during the manufacturing process.Historical data analysis: the entire batch was sold between (b)(6) 2022.No further complaints have been received since delivery to rwmic or other customers.Risk analysis: the risk of sharp edges due to use errors was considered in the risk assessment "d3: reusable shafts, tubes" and classified as acceptable after implementing appropriate risk reduction measures and taking into account the remaining probability of occurrence.

• Brand Name: SHARK
• Common Device Name: INTERNAL SHEATH RESECTOSCOPE 22FR
• 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: 22862032
• Report Number: 9611102-2025-00045
• Device Sequence Number: 15359255
• Product Code: FJL
• UDI-Device Identifier: 04055207019641
• UDI-Public: 04055207019641
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/02/2025

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: 8675322
• Device Catalogue Number: 8675322
• Device Lot Number: 1500752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• 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