MAUDE Adverse Event Report: RICHARD WOLF GMBH RIWO D-URS; SENSOR-URETERORENOSCOPE 9FR WL 600MM

Model Number 473572076

Device Problems No Display/Image (1183); No Visual Prompts/Feedback (4021)

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

Event Date 02/20/2023

Event Type  malfunction  

Event Description

A user facility representative has informed richard wolf gmbh an issue regarding a sensor-ureterorenoscope 9fr wl 600mm flexible, part id: 473572076, batch # p347488-04.According to the received information: "when using the riwo d-urs, the image was suddenly gone during surgery.A second d-urs was open, also no image.The surgery was eventually continued and completed by the use of a cobra vision from richard wolf gmbh." there was a 30-minute delay in the procedure.The patient condition was described as "good".

Manufacturer Narrative

The device was pre-examined at richard wolf austria with the following result: "when connecting the d-urs with adapter plug 5525410 to the logic hd controller, the following message appears: test image "error - application part cannot be initialized.".

Manufacturer Narrative

New information: b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h7, and h10.The user facility has returned 2 pieces of the sensor-ureterorenoscope 9fr wl 600mm 473572076, batch # p347488-04 for investigation.The investigation was carried out by the responsible development department.It was determined that the root cause of the image failure is user-indicated damage to the head of devices included the image module.A thermical damage by using a laser is clearly visible on the head of the devices.At both devices, the plastic material of the endoscope head was thermically damaged so that the underlying image and sensor modules can be seen.Consequently, the thermal laser energy also damaged the sensor module.In this case, the laser fiber was inserted via the working channel instead of the laser channel.The device will be disposed.The sensor-ureteroreniscope 9fr wl 600mm 473572076, batch # p347488-04 was manufactured on 30/may/2022.The batch consisted of 10 paks.One pak consists 3 devices.No issue was identified during production.No further complaints were received regarding the reported device failure neither from the same batch nor from other batches in the review period of 01/jan/2020 and 24/jan/2023.The ifu ga-d394 / en-us / 2021-01 v1.0 / pk00-0000 contains several safety instructions and notes regarding the use of laser fiber in section 7 illustration and in section 8.2.3.1 lasers.The subject issue of image loss is present in the risk management file aa4: not reusable flexible video optics, document version v02.The overall probability of occurrence for this issue remains at previously defined levels and overall risk of the device remains in the acceptable category.

• Brand Name: RIWO D-URS
• Type of Device: SENSOR-URETERORENOSCOPE 9FR WL 600MM
• 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: zsófia bartholome-nagy ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 16659441
• MDR Text Key: 313407645
• Report Number: 9611102-2023-00021
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04055207064177
• UDI-Public: 04055207064177
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K201897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

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
• Device Operator: Health Professional
• Device Model Number: 473572076
• Device Catalogue Number: 473572076
• Device Lot Number: P347488-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 04/05/2023
• Supplement Dates FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other