MAUDE Adverse Event Report: RICHARD WOLF GMBH URETERORENOSCOPE

Model Number 8702.518

Device Problems Display or Visual Feedback Problem (1184); Optical Problem (3001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4) contacted the user facility in an attempt to obtain additional/missing information, but no additional information could be provided.Device labeling was reviewed for patient and device codes: patient code - not applicable, no patient problem was reported.Device code - the following cautions were found in the device labeling: 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.Important! do not forcefully insert the laser fiber.The laser fiber may become damaged and break.To protect the laser fiber we recommend straight insertion.Caution! the endoscope tip may become damaged during the intervention! to avoid damage to the endoscope tip by electrohydraulic shock waves, during activation the ehl probe must have a safe distance of at least 10 mm from the distal end of the sheath.Caution! do not work outside the scope's field of view! inadvertent tissue damage as well as damage to the distal end of the fiber uretero-renoscope and other instrument parts are possible! (b)(4) considers this matter closed.However, in the event (b)(4) receives additional information, a follow up report will be submitted to the fda.

Event Description

On september 17, 2018, the user facility reported the following to (b)(4): while being used on a patient, the image came out as foggy.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Specifically, was the device being used on a patient when the issue occurred? yes.Was there any injury or illness to patient or other personnel due to issue? no.Did the issue cause a delay in the procedure being performed that put the patient at risk? yes.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.How was the patient anesthetized? general.The user facility returned the device to (b)(4) on 04 oct 2018 and the investigation was completed on 10 oct 2018.The device appeared to be used - the distal end surface appeared to be damaged, the fiber was broken, and the lenses were coming apart.The reported condition was confirmed by visual and functional testing using a microscope and camera setup.Probable root cause was determined to be user handling.The device was repaired.

Manufacturer Narrative

Follow-up report #1 is to provide fda with new and changed information.Richard wolf medical instruments corporation (rwmic) considers this case closed.In the event that rwmic receives additional information a follow up report will be submitted to the fda.

Event Description

Follow-up report #1 is to provide fda with new and changed information.

• Brand Name: URETERORENOSCOPE
• Type of Device: URETERORENOSCOPE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 7975655
• MDR Text Key: 126153508
• Report Number: 1418479-2018-00031
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04055207019993
• UDI-Public: 04055207019993
• Combination Product (y/n): N
• PMA/PMN Number: K990050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/26/2019,09/17/2018

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: No Information
• Device Model Number: 8702.518
• Device Catalogue Number: 8702.518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/26/2019
• Distributor Facility Aware Date: 09/17/2018
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2019
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/17/2018
• Supplement Dates Manufacturer Received: 04/05/2019
• Supplement Dates FDA Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other