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

Model Number 8703.534

Device Problems Positioning Failure (1158); Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The instrument has not yet been sent for examination by the user.As soon as the examination is completed, we will send a follow-up report.

Event Description

It was reported to richard wolf "on (b)(6) 2021, fibrous ureteroscopic holmium laser lithotripsy was performed.In the process of lithotripsy, the fibrous ureteroscope failed to bend suddenly and kidney stones could not be found, so the operation was aborted.No information is known about the patient's state of health.".

Manufacturer Narrative

Follow-up report #1 is to provide fda with missing information (results of the device evaluation/investigation), new information, and changed information.The following is the results of the device investigation/evaluation as reported by the manufacturer: using process: on (b)(6) 2021, fibrous ureteroscopic holmium laser lithotripsy was performed.In the process of lithotripsy, the fibrous ureteroscope failed to bend suddenly and kidney stones could not be found, so the operation was aborted.Detail of the investigation: after checking, this scope had problem during operation, so the operation was aborted.After that, hospital sent it for a third party company for repair, now it is in normal use.Analysis of cause: normal wear.Instructions for use: the hospital found a third party who carried out the repair himself.The instrument has signs of third-party repair, as a result of which it does not correspond to the specifications given by richard wolf gmbh and it can be ruled out that the instrument was delivered in this condition.This means that richard wolf is no longer the manufacturer of the product.All claims against richard wolf are extinguished by the third-party repair.Product risk: the hospital found a third party who carried out the repair himself.The instrument has signs of third-party repair, as a result of which it does not correspond to the specifications given by richard wolf gmbh and it can be ruled out that the instrument was delivered in this condition.This means that richard wolf is no longer the manufacturer of the product.All claims against richard wolf are extinguished by the third-party repair.Richard wolf gmbh considers this matter closed.However, in the event rwgmbh receives any additional information a follow up report will be submitted to fda.Richard wolf medical instruments corporation(rwmic) submitting report on behalf of rwgmbh report.

Event Description

Please see manufacturers narrative for device evaluation/investigation results.

• Brand Name: E-LINE
• Type of Device: URETERORENOSCOPE 12° 8/9.8FR WL 430MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• MDR Report Key: 12705292
• MDR Text Key: 285739317
• Report Number: 9611102-2021-00035
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04055207018798
• UDI-Public: 04055207018798
• 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: Other,User Facility
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• 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
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1