MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-4 100V; ENDOSCOPE REPROCESSOR

Model Number OER-4

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to any of olympus locations.The user facility requested that the device be checked for abnormalities, and an olympus representative visited the user facility on july 21, 2021.No detailed information about the device evaluation result has been provided yet.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that as a result of the annual culture testing by the user facility, bacteria were detected from the olympus gastrointestinal videoscope gif-h260z with serial number (b)(4) washed using the device.Samples were collected by a nurse in the endoscopy room on (b)(6) 2021 and cultured in the user facility.As a result of the testing, the sample collected by sending sterile water and purified water to the air/water channel of the videoscope gif-h260z with serial number (b)(4)tested positive for escherichia coli (3 cfu).The device used the peracetic acid-based disinfectant acecide to clean the videoscope gif-h260z for 1 minute and disinfect it for 5 minutes.The disinfectant concentration was within the effective concentration and the water filter was last replaced on june 3, 2021.There was no report of infection associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The device was not returned to any of olympus locations.Olympus medical systems corp.(omsc) checked the reprocessing checklist provided by the user facility and confirmed that bacteria were detected in the air/water channel of the olympus gastrointestinal videoscope gif-h260z and that the user was not using the aw channel cleaning adapter.Therefore, it is possible that the videoscope gif-h260z could not be reprocessed properly due to the unconnected aw channel cleaning adapter.Alternatively, as described in "8.1 troubleshooting guide" in the instruction manual, there is a possibility that the service life of each filter has expired, the disinfectant solution has deteriorated, and the water supply piping has not been disinfected.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.

• Brand Name: OER-4 100V
• 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: 12278509
• MDR Text Key: 265609673
• Report Number: 8010047-2021-09807
• 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: Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

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: OER-4
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 10/15/2021
• Supplement Dates FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1