MAUDE Adverse Event Report: RICHARD WOLF GMBH E-LINE; INTERNAL SHEATH RESECTOSCOPE 26FR

Model Number	86553841
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the facts available, richard wolf gmbh has classified this case as a reportable malfunction.The assessment was made based on the following facts: the time delay of less than 30 minutes posed a risk to the patient due to the prolonged anesthesia time.Additional medical measures were necessary, but the procedure remained the same, namely "minimally invasive"; however, the treatment of this procedure was new, namely the retrieval of the lost fragment.Since the procedure remained minimally invasive and the fragment could be retrieved, we consider the warnings instructions in the applicable ifu to be effective.The ifu ga-d345 /usa / 2011-11 v4.0 / eco 2011-0484 contain the following warnings 8 checks caution! be careful if products are damaged or incomplete.Injuries of the patient, user or others are possible.Run through the checks before and after each use.Do not use the products if they are damaged, incomplete or have loose parts.Return damaged products together with any loose parts for repair.Do not attempt to do any repairs yourself.8.1 visual check the instruments and accessories for damage, sharp edges, loose or missing parts and rough surfaces.Check the insulation with particular care.
Event or Problem Description
The facility reports that after the case was completed, it was found that part of the ceramic tip of the resectoscope's inner sheath was broken, and a fragment was missing.Fluoroscopy was performed in the room and the fragment was identified in the patient's bladder.There are no reports of injury, but there was a delay of less than 30 minutes, which put the patient at risk due to the prolonged anesthesia time.In addition, additional medical measures were necessary.

• Brand Name: E-LINE
• Common Device Name: INTERNAL SHEATH RESECTOSCOPE 26FR
• 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: 22337722
• Report Number: 9611102-2025-00027
• Device Sequence Number: 13010303
• Product Code: FDC
• UDI-Device Identifier: 04055207028094
• UDI-Public: 04055207028094
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2025

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: 86553841
• Device Catalogue Number: 8655.3841
• Device Lot Number: 1183100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2012
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Male