MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPE REPROCESSOR

Model Number OER-S

Device Problem Contamination (1120)

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

Event Type  Injury  

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.

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 potential cross contamination of cyf-va2 by 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 potential cross contamination of cyf-va2 by 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

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additional information was received regarding the reported issue (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).The cyf-va2 and cyf-vha were alternately used for the applicable procedures, and it is not possible to identify which of the two scopes may have caused infection in the corresponding patients.The cyf-va2 and cyf-vha were replaced with substitute devices.After the devices were replaced, no patients have returned to the facility after the procedures were performed, and no further urinary tract infections were reported.The customer performed a culture test on the cyf-va2 and cyf-vha and no bacterial growth was identified.However, escherichia coli and klebsiella pneumoniae (growing colonies: 300) were detected from the forceps/irrigation plug that was used in combination with the cyf-vha.The users felt that the detected bacteria could lead to the reported symptoms (fever, pain during urination, etc.).A review of the device history record for the oer-s (subject device) found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the oer-s was manufactured.Based on the results of the investigation, additional information was received that confirmed the hospital does not disinfect the oer-s water supply pipes.According to the culture test report of the oer-s, there was no growth of bacteria identified.Since the water supply pipeline had not been disinfected, it is possible that the inside of the pipeline had become contaminated.However, since no bacteria growth was observed, the cause could not be determined.The device's instructions for use (ifu) states that the water supply piping should be disinfected when the water filter is replaced.In addition, the ifu provides the following: "warning: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who contact them.¿ olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received from the customer.The investigation is ongoing.A supplemental report will be submitted once the investigation is complete.

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: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• 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: 15126225
• MDR Text Key: 296846362
• Report Number: 8010047-2022-12113
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2022

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: OER-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 10/13/2022; 11/15/2022
• Supplement Dates FDA Received: 11/09/2022; 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2013
• 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