MAUDE Adverse Event Report: RICHARD WOLF GMBH E-LINE; URETERORENOSCOPE

Model Number	8703.534
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.The device has currently not been returned by the user to richard wolf (b)(4).A follow-up report will be submitted as soon as the investigation is completed.
Event or Problem Description
It was reported that a (b)(6) year old patient was admitted to the hospital at 9:25 am on (b)(6) 2020 for "kidney stones", and underwent nephroscope surgery at 10:00 am on (b)(6).During the operation, the fiber ureteral nephroscope was broken and immediately stopped using.

• Brand Name: E-LINE
• Common Device Name: URETERORENOSCOPE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10338886
• Report Number: 9611102-2020-00017
• Device Sequence Number: 1875257
• Product Code: FGB
• UDI-Device Identifier: 04055207020104
• UDI-Public: 04055207020104
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/29/2020

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: Health Professional
• Device Model Number: 8703.534
• Device Catalogue Number: 8703.534
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR