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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ceramic tip of the sheath came off inside of the patient's bladder during the holep (holmium laser enucleation of the prostate) procedure.The surgery was prolonged by 15 minutes retrieving the broken piece.The surgeon was able to remove the foreign object without issue and confirmed that no pieces remained in the patient.Upon review, it appears the sheath has separated into two pieces and is no longer adhering as intended.There are no reports of injuries, and the planned procedure was performed using a back-up device.
Additional Manufacturer Narrative
Since the user concluded that the extended procedural time may have presented unnecessary risk to the patient health, richard wolf gmbh consider this case to be a reportable malfunction.

• 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: 24832239
• Report Number: 9611102-2026-00012
• Device Sequence Number: 9168573
• Product Code: FDC
• UDI-Device Identifier: 04055207028094
• UDI-Public: 04055207028094
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

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: 1477720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• 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