MAUDE Adverse Event Report: RICHARD WOLF GMBH E-LINE; URETERORENOSCOPE 12° 8/9.8FR WL 430MM

Model Number	8703524
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A distributor has informed richard wolf gmbh (rwgmbh) of an issue regarding a ureterorenoscope 12° 8/9.8fr wl 430mm, part id: 8703.524, s/n # (b)(6).According to the received information, a planned lithotripsy could not be performed because an image failure occurred during the application.The procedure was cancelled.

• Brand Name: E-LINE
• Common Device Name: URETERORENOSCOPE 12° 8/9.8FR WL 430MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• 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: 18438631
• Report Number: 9611102-2023-00078
• Device Sequence Number: 20748379
• Product Code: FGB
• UDI-Device Identifier: 04055207020081
• UDI-Public: 04055207020081
• Combination Product (Y/N): N
• PMA/510(K) Number: K963855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2024

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: Health Professional
• Device Model Number: 8703524
• Device Catalogue Number: 8703.524
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2023
• 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