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	01/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the received information, "during the operation, part of the insertion tip of the obturator broke off / shattered in the urinary bladder." during the retrieval, the tip parts were cut / divided again by the surgeon due to their size, so that retrieval was possible.Presumably, all parts were fully retrieved.The fragmentation and retrieval of the fragment prolonged the procedure by about 40 minutes.The scheduled surgical procedure was completed, and no patient harm was reported.
Additional Manufacturer Narrative
The inner shaft was sent to (b)(6) (rwgmbh) for examination.On the distal side, the insulation insert made of a ceramic material has broken off.The production order for internal sheath resectoscope 24fr, 8675324, batch 1487398 consists of 23 sheaths.(b)(4) units out of this batch were sold to (b)(6) hospital of on (b)(6) 2021.In april 2023, one inner shaft from this batch 1487398 was due for inspection at rwgmbh.Only the 0-rings had to be replaced.Since then, no further complaints have been received about the interior shaft for resectoscope 24fr from batch 1487398.In general, the user is advised in the associated instructions for use ga-d366-us / en / 2017-02 v4.0 under chapter 8, that a visual check must be carried out before and after each use.In chapter 8.1.2 "shark" resectoscopes, explicit reference is made to the material properties of the ceramic material.A warning regarding inappropriate handling, e.G.Dropping, impact, shock or similar mechanical stresses can lead to hairline cracks and / or spalling of the ceramic coating in the distal area of the resectoscope sheath.It is expected that, with close personal monitoring of the patient during an intervention, missing parts will be discovered before the intervention is completed.The probability that the reported problem will result in death, life-threatening injury, or permanent impairment of body structure is therefore low.No unscheduled medical procedures were required.The removal of the broken tip extended the total time for the operation by about 40 minutes.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: oliver ehrlich ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 21345083
• Report Number: 9611102-2025-00003
• Device Sequence Number: 7854271
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 8675324
• Device Catalogue Number: 8675324
• Device Lot Number: 1487398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown