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

Model Number 8703524

Device Problem No Display/Image (1183)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2023

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 331865807
• Report Number: 9611102-2023-00078
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04055207020081
• UDI-Public: 04055207020081
• Combination Product (y/n): N
• PMA/PMN Number: K963855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 8703524
• Device Catalogue Number: 8703.524
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/12/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other