MAUDE Adverse Event Report: Richard Wolf GmbH; FIBER-CYSTOSCOPE 15FR WL 400MM

Model Number	7305001
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Malfunction

• Common Device Name: FIBER-CYSTOSCOPE 15FR WL 400MM
• 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: 50857504
• Report Number: 9611102-2026-00063
• Device Sequence Number: 9652092
• Product Code: FAJ
• UDI-Device Identifier: 04055207013656
• UDI-Public: 04055207013656
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K980401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 7305001
• Device Catalogue Number: 7305.001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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
• Patient Sex: Unknown