MAUDE Adverse Event Report: RICHARD WOLF GMBH E-LINE; URETERORENOSCOPE 5° 6.5/8.5FR WL 430MM

Model Number	8708.518
Medical Device Problem Codes	Poor Quality Image (1408); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Rwmic reference complaint no.(b)(4).On august 10, 2022, it was reported to richard wolf medical instruments corp.(rwmic) by a user facility representative regarding product id# 8708.518 sn (b)(4)."this ureteroscope was just repaired, however when we went to use it was brown and cloudy.We were unable to use this ureteroscope to complete the case.(ra# from previous repair- (b)(4))." additional information reported by the user facility representative: (email, dated august 10, 2022)."we had to flash the other long ureteroscope, so it was a 30 minute delay." will the device be returned? yes.Was the device being used on a patient when the reporting issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? no.Was there any injury or illness to any other personnel due to the reported issue? no.Did the issue cause a delay in the procedure being performed? yes.Did the delay put the patient at risk? no.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.New information obtained from the user facility representative: (email, dated august 30, 2022)."i know it was a ureteroscopy that was being done for a ureteral calculus.We had to use another scope to complete the procedure." decision to report from rwgmbh: based on the received information, there was a delay of 30 minutes, which put the patient at risk.No harm to patient was reported and the procedure was completed with a back-up device.Mdr shall be filed as malfunction.Rwmic mdr awareness date: 10-aug-2022.Also, the purpose of this submission is to provide the results of the device investigation.
Additional Manufacturer Narrative
Richard wolf medical instruments corporation is the importer of this device.Rwmic is submitting this report on behalf of richard wolf gmbh (manufacturer).Device investigation results: rwmic investigation report device evaluation, form 5020 (12) the device was tested visually and functionally.The reported condition was confirmed and the device did not meet specifications.The evaluation found that the scope was received with a cloudy image.Based on the photos the scope was used after the previous repair and not properly clean.The cloudy image is caused by accumulation of debris on front lens.Maintenance was recommended on the device.Probable root cause: due to reprocessing.The instruction manual ga-d 352 / usa / 2012-11 v4.0 / eco: 2012-0540 contains the following applicable warnings for these faults: 7.2.3 image quality.Caution! increased risk potential if the image is blurred! danger of injuring the patient.Stop the intervention for safety reasons if the image is blurred.Check the image quality of the endoscope before use (section 8.2).8.2.1 checking image quality and light output check image quality and light output in conjunction with the system components.Deposits on the glass surfaces can cause a spotted or blurred field of view and hence impair light transmission considerably.Wipe the glass surfaces with a swab soaked with alcohol (wooden swab carrier, not metal or plastic), remove hard-to-remove deposits with instrument cleaner.Check the light output without the system components.Hold the distal end of the endoscope towards a light source.Broken fibers appear as black dots at the cold-light connector.If approx.30% of the fibers are broken, the light output is no longer adequate.9 reprocessing procedures important! when used as intended and when following the instruction manual, it is not necessary to limit the number of possible reprocessing cycles.Careful and gentle handling of medical products during the entire reprocessing process has an essential influence on the service life of the products.Before returning defective products for repair, they must have gone through the entire reprocessing cycle.The user is obliged to make sure that the reprocessing process including the resources, materials and personnel is suited to yield the required results.Follow the national and international requirements on validation.Important! do not sterilize the products in hot-air sterilizers.Additionally, on august 26, 2022, a follow-up email was sent to the user facility together with the sales representative regarding the patient information.However, no further information is available per user facility.(email reply, 8/30/2022).Rw considers this matter closed.However, if a new information becomes available, rw will submit a follow-up report.

• Brand Name: E-LINE
• Common Device Name: URETERORENOSCOPE 5° 6.5/8.5FR WL 430MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; 75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer Contact: zsófia bartholome-nagy ; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• MDR Report Key: 15363671
• Report Number: 9611102-2022-00042
• Device Sequence Number: 6450966
• Product Code: FGB
• UDI-Device Identifier: 04055207020159
• UDI-Public: 04055207020159
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other,Inspection
• Type of Report: Initial
• Report Date (Section B): 09/06/2022

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 Model Number: 8708.518
• Device Catalogue Number: 8708.518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown