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

Model Number CYF-VHA

Device Problem Contamination (1120)

Patient Problems Fever (1858); Pain (1994); Urinary Tract Infection (2120); Chills (2191); Urinary Frequency (2275)

Event Type  Injury  

Event Description

The customer reports over the last 1-2 months, a cluster of five patients have been infected with urinary tract infections after endoscopy using one of two cystoscopes that were processed in an oer-s.Case with patient identifier (b)(6) reports patient 1 of 5 -scope (cyf-vha).Case with patient identifier (b)(6) reports patient 2 of 5 -scope (cyf-vha).Case with patient identifier (b)(6) reports patient 3 of 5 -scope (cyf-vha).Case with patient identifier (b)(6) reports patient 4 of 5- scope (cyf-vha).Case with patient identifier (b)(6) reports patient 5 of 5- scope (cyf-vha).Case with patient identifier (b)(6) reports second scope processed in the oer-s (cyf-va2).(potential for cross contamination).Case with patient identifier (b)(6) reports patient infection 1 of 5 potentially related to oer-s.Case with patient identifier (b)(6) reports patient infection 2 of 5 potentially related to oer-s.Case with patient identifier (b)(6) reports patient infection 3 of 5 potentially related to oer-s.Case with patient identifier (b)(6) reports patient infection 4 of 5 potentially related to oer-s.Case with patient identifier (b)(6) reports patient infection 5 of 5 potentially related to oer-s.Case with patient identifier (b)(6) reports potential cross contamination of cyf-va2 by oer-s.Case with patient identifier (b)(6) reports the maj-891 used by the ore-s for the reprocessor.More than a year ago, there was something like green algae growing on the water filter.In view of this, the facility is concerned about infection caused by oer-s.At that time, the facility staff did not find any abnormalities after the response, so the process was completed without any problems, and there was no problem with the frequency of filter replacement at the facility noted.Microbiological investigation of the reported reprocessor indicates the oer-s is not the source of infection in the reported patients.Additional details regarding the patients and reported events have been requested.At this time, no additional information has been provided.

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the user¿s experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

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.It has been almost 8 years since the subject device was manufactured.Based on the results of the investigation, the customer performed a culture test on the scopes cyf-va2 and cyf-vha, but bacterial growth was not confirmed.Therefore, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿warning: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who contact them.¿ this supplemental report includes information added to b5, d4, d8, g2 and h4.Olympus will continue to monitor field performance for this device.

Event Description

The following additional information regarding the reported event was received: all five patients experienced fever, chills, pain when urinating, and frequent urination.The patients were prescribed antibiotics at the time of the endoscopy.Although the patients were hospitalized for fever, upon re-examination, the patients recovered and reported to be in good condition.The physician suspects the possibility of olympic equipment contributing to the infections due to the large number of patients returning with almost identical symptoms approximately ten days after each endoscopic procedure.There were no additional instruments used during the procedures.Although, additional information regarding the patients and the occurrence of disease were requested, no additional information was obtained.

• 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: 15124224
• MDR Text Key: 296842543
• Report Number: 3002808148-2022-00419
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411274
• UDI-Public: 4953170411274
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-VHA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 10/13/2022
• Supplement Dates FDA Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2014
• 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
• Patient Outcome(s): Other