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

Model Number 8703.534

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2020

Event Type  malfunction  

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 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
• Type of Device: URETERORENOSCOPE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10338886
• MDR Text Key: 204759518
• Report Number: 9611102-2020-00017
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04055207020104
• UDI-Public: 04055207020104
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K963855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8703.534
• Device Catalogue Number: 8703.534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 58 YR