MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE

Model Number URF-V3

Device Problems No Display/Image (1183); Peeled/Delaminated (1454)

Patient Problem Unspecified Kidney or Urinary Problem (4503)

Event Date 06/14/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was returned to olympus for physical evaluation.Preliminary findings are reported.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.Physical evaluation of the suspect device reveals: the plastic over has a minor dent.The rubber glue is lifted with sharp/loose edges.No moisture was found in the scope connector or video connector.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported during a therapeutic ureteroscopy using a uretero-reno-videoscope, the image was lost during the case resulting in a tear in the ureter.A disposable lithovue was used to finish the case.Additional details regarding the patient and event were requested.The customer stated the patient is no longer in their care and no further information can be provided.

Manufacturer Narrative

This report is being updated to provide additional information received from the customer.

Event Description

Update: new information provided by the customer: the patient has an ostomy with a double pigtail ureteral stent (jj) and no leaks - the patient is recovered and is expected to have no permanent damage or loss following the removal of the jj and the tapering of the ostomy.

Manufacturer Narrative

This report is being updated to provide investigation findings.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: withdrawal of the endoscope with an irregularity: if an irregularity occurs while the endoscope is in use, take proper measures as described on page 70, or ¿withdrawal when no endoscopic image appears on the monitor or a frozen be restored¿ on page 71: after withdrawal, return the endoscope for repair as described in section 5.4, ¿returning the endoscope for repair¿.If the endoscope or endotherapy accessory cannot be withdrawn from the patient smoothly, do not attempt to forcibly withdraw it.Rather, withdraw the endoscope or endotherapy accessory carefully.If the endoscope or endotherapy accessory cannot be withdrawn from the patient, consider removing it through open surgery and take proper measures.Forcibly withdrawing the endoscope or endotherapy accessory may cause patient injury, bleeding, and/or perforation.If any irregularity with the endoscope or endotherapy accessory is observed, contact olympus.Troubleshooting: if any irregularity is observed during the inspection described in chapter 3, ¿preparation and inspection¿, do not use the endoscope and solve the problem as described in section 5.2, ¿troubleshooting guide¿.If the problem still cannot be resolved, send the endoscope to olympus for repair as described in section 5.4, ¿returning the endoscope for repair¿.Also, should any irregularity be observed while using the endoscope, stop using it immediately and withdraw the endoscope from the patient as described section 5.3, ¿withdrawal of the endoscope with an irregularity¿.Additional information regarding device evaluation: olympus performed a functional inspection on the received condition and was unable to replicate the user's complaint during the inspection.For testing, olympus connected the complaint device to a cv-190 processor, in conjunction with the clv-190 light source.The processor was powered on with the urf-v3 connected, and the image displayed normal on the monitor.The insertion tube, light guide tube, video cable, and bending section were manipulated during the inspection and there were no signs of image loss.Additionally, the distal end was submerged into a beaker of warm water (55°-65°c) for 1 hour and then immersed into a cup of water, which measured at 15 degrees celsius, as part of fog test inspection.There was no change in the image during, or after the fog test.Olympus tested the complaint device on three different processors and the outcome was the same.The switches function properly and correspond to their intended function.Upon visual inspection, olympus noted, the objective lens and bending section normal.The scope connector and control body are both dry, free of fluid.The bending section cover glue is damaged on both ends.The damages to the bending section cover glue consist of chips, cracks, and openings around the edges.A second technician inspected the complaint device also and was unable to replicate the user's experience.The electrical contacts on the video connector show no signs of moisture, or corrosion.The scope was tested on two different cv-190 systems and the image focus test passed.The connector, bending section, light guide tube was manipulated, and the image was still normal.The bending section was angulated to the max in both up and down directions, image remained normal.The definitive cause of the reported event could not be determined.The user's report could not be replicated.Although minor defects were noted in the suspect device upon inspection, the identified defects are not likely to cause the loss of image reported by the customer (that led to the ureter injury).

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12157810
• MDR Text Key: 261203184
• Report Number: 8010047-2021-08737
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403385
• UDI-Public: 04953170403385
• Combination Product (y/n): N
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 07/13/2021
• Supplement Dates Manufacturer Received: 07/19/2021; 09/27/2021
• Supplement Dates FDA Received: 07/19/2021; 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other