MAUDE Adverse Event Report: RICHARD WOLF GMBH MIDI-SIZE; SHEATH RESECTOSCOPE 14.5FR

Model Number	86770155
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device investigation is still on-going.
Event or Problem Description
It was reported that the ceramic tip came off inside of the patient during the procedure.The surgery was prolonged by an hour retrieving the fallen piece.Due to it, the patient required additional anesthesia.There was no report of injury to the patient, and the planned procedure was completed using a back-up device.

• Brand Name: MIDI-SIZE
• Common Device Name: SHEATH RESECTOSCOPE 14.5FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 25220647
• Report Number: 1418479-2026-00002
• Device Sequence Number: 15902126
• Product Code: FDC
• UDI-Device Identifier: 04055207028230
• UDI-Public: 04055207028230
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/19/2026
• Report Date (Section F): 05/19/2026

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
• Device Model Number: 86770155
• Device Catalogue Number: 86770155
• Device Lot Number: 1579103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2026
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/06/2026
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2026
• 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
• Date Report Sent to FDA: 05/19/2026