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

Model Number URF-V3

Device Problems Corroded (1131); Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

The device is returned and an evaluation completed for it.Upon inspection of the device, it was observed that the angulation of the device cannot be performed.This is attributed to the internal rusting of the angulation mechanism.The control knob up/down movement cannot be performed.Other observations for the device are: leaking observed in biopsy channel; the distal end rubber coating (a-rubber) glue is lifting and has scratches; corrosion inside control body; and image is blurry.The user¿s complaint of bad image is confirmed.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

Customer returned the device for the evaluation and repair of the issue of bad image and broken end.There is no reported harm to any patient or persons.Upon evaluation of the returned device, it was observed that the angulation of the device cannot be performed.This is attributed to the internal rusting of the angulation mechanism.This medwatch is being submitted for the reportable issue of angulation malfunction due to rusting as observed during device evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that leakage occurred from the biopsy channel due to inappropriate accessory handling.Water invaded from the point, the bending mechanism was rusty, which caused unable to angulation.The following is included in the instructions for use (ifu): "inspection of the endoscope-inspection for smooth operation-operate the up/down angulation control lever slowly in each direction until it stops.Confirm that the bending section angulates smoothly and correctly and confirm that maximum angulation can be achieved." "warnings and cautions: operation-if any of the following conditions occur during an examination, immediately stop the examination and withdraw the endoscope from the patient as described in section, ¿withdrawal of the endoscope with an irregularity¿." "continued use of the endoscope under these conditions could result in patient injury, bleeding, and/or perforation." "warnings and cautions: operation-if an abnormal endoscopic image appears or an abnormal function occurs but quickly corrects itself, the endoscope may have malfunctioned.In this case, stop using the endoscope because the irregularity can occur again and the endoscope may not return to its normal condition.Stop the examination immediately and slowly withdraw the endoscope while viewing the endoscopic image.Otherwise, patient injury, bleeding, and/or perforation can result." "precautions-perform a leakage test on the endoscope after each precleaning procedure.Do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions.Use of a leaking endoscope may also pose an infection control risk." "inspection of the instrument channel- use endotherapy accessories with the same color code (ø 1.2 mm channel or less).The endoscope and/or the endotherapy accessory may be damaged." "inspection of the instrument channel-if significant resistance is encountered and insertion becomes very difficult, straighten the bending section as much as possible without losing the endoscopic image.Inserting endotherapy accessories with excessive force may damage the endoscope and/or the endotherapy accessories." "inspection of the instrument channel- confirm that the tip of the endotherapy accessory is closed or retracted into its sheath and slowly insert the endotherapy accessory into the forceps port of the sealing accessory.Do not open the tip of the endotherapy accessory or extend the tip of the endotherapy accessory from its sheath while inserting it into the channel.The endoscope and/or the endotherapy accessory may be damaged." olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14452438
• MDR Text Key: 300350018
• Report Number: 8010047-2022-08516
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403385
• UDI-Public: 04953170403385
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• 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: 04/25/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1