MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VH

Device Problems Device Reprocessing Problem (1091); Contamination /Decontamination Problem (2895)

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

Event Date 09/01/2022

Event Type  malfunction  

Event Description

The customer requested an in-service from olympus to aid in the facility¿s reprocessing techniques related to their olympus cysto-nephro videoscope.During the in-service, it was discovered that the subject device had been insufficiently reprocessed as no bedside cleaning nor leak tests were performed ((b)(6)).The customer then went on to note that in a previous week, the same cysto-nephro videoscope had black foreign material coming from it after a case (please see reported with patient identifier (b)(6)).The customer went on to explain that this same device was used a second time, on a new patient and the same black foreign material was seen during and after the case (please see reported with patient identifier (b)(6)).At that time, the olympus representative informed the staff that scope was compromised and not suitable for use.That was when the staff informed the olympus representative that the scope was currently in another room with the physician, in use (please see reported with patient identifier (b)(6)).Additional details relating to the patient and the event have been requested, but no response has been received at this time.There was no patient harm or consequence reported as a result of this event.This is report 4 of 4.For the remaining related files, please see reports with patient identifiers: (b)(6).

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user¿s report was confirmed ¿ the subject device was leaking from both the instrument channel and the forceps channel.Additionally, the distal end was detached, and the number one switch was not functioning properly.Several of the device¿s components were removed and replaced.Following those replacements, the subject device was tested and confirmed to be back at the manufacturer¿s specifications.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Manufacturer Narrative

This report is being submitted to capture additional information received from the initial reporter.That information is located in event.Should further information be provided, another supplemental report will be submitted.

Event Description

Additional information was received from the initial reporter claiming that there was only 1 procedure, not 3.Per the initial reporter, the subject device was inspected prior to use, and she was told that there was water build up that needed recleaned.The procedure being performed was a cystoscopy.The procedure was completed with the subject device as the issue was not noticed until after the scope was removed from the patient.Reportedly, there was no harm to the patient as a result of this event.Despite the customer's most recent claim, the related complaint files: (b)(6) will all remain open to continue to record the initially reported events.

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.Approximately 4 years have passed since the device was manufactured.Based on the results of the legal manufacturer's investigation, it is likely that the liquid residue or objects inside the forceps channel resulted from improper reprocessing.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): chapter 1 general policy: 1.4 precautions: warning: 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.Chapter 5 reprocessing the endoscope: 5.3 precleaning the endoscope: warning: if the endoscope and accessories used in the patient procedure are not immediately cleaned after each patient procedure, residual organic debris will begin to dry and solidify, hindering effective removal and reprocessing efficacy.Preclean the endoscope and the accessories at the bedside immediately after each patient procedure.Olympus will continue to monitor the field performance of this device.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15485139
• MDR Text Key: 306408661
• Report Number: 3002808148-2022-02433
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411250
• UDI-Public: 04953170411250
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2022

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 Operator: Health Professional
• Device Model Number: CYF-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/26/2022
• Supplement Dates Manufacturer Received: 09/26/2022; 10/25/2022
• Supplement Dates FDA Received: 09/28/2022; 11/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2018
• 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