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

Model Number OER-4

Device Problems Device Reprocessing Problem (1091); Communication or Transmission Problem (2896)

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

Event Date 06/14/2022

Event Type  malfunction  

Event Description

The customer reported that his olympus endoscope reprocessor was presenting error code e99 while reprocessing prior to a diagnostic procedure.According to the initial reporter, the intended procedure was completed without any harm to the patient.Additional details were requested, but no answers were provided.

Manufacturer Narrative

The customer called into olympus to report his event.During the call, the customer informed olympus about the issue and how it has been re-occurring (please see reports with patient identifiers: (b)(6) & (b)(6) for related events).During the call, the customer noted that he replaces the reprocessing solution once a week.He went on to explain that the solution concentration check was not been performed, even after the error code was displayed.Customer continued noting that the scope was reprocessed and used in the next case.The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.

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 (dhr) found no deviations that could have caused or contributed to the reported problem.The dhr confirmed that the subject device was shipped in accordance with the specifications.The investigation concluded that the reported event occurred because the end-user did not adequality follow the device¿s instructions for use (ifu).More specifically, the end-user did not check the concentration level of the acecide solution before the endoscope was cleaned/disinfected.Per the ifu, the acecide solution should be replaced every 15 days, or after it has been used 46 times.This instruction was not followed and was identified as the root cause of the reported problem.The occurrence of the reported issue can be prevented by adhering to the ifu which states the following: ¿chapter 3 inspection before use 3.9 checking the disinfectant solution concentration level on reprocessing an endoscope, always use an acecide checker or a portable concentration checker to check that the disinfectant solution is at an effective concentration.Please be sure to replace the disinfectant solution before the disinfectant effect disappears.¿ olympus will continue to monitor field performance for this device.

Event Description

Additional information was received noting that the field service engineer (fse) spoke with the facility and impressed on them the importance of properly reprocessing the subject device using the indicated methods from the instructions for use (ifu).Facility stated that they would consider improving their operations in the future.

Manufacturer Narrative

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

• 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: 14956002
• MDR Text Key: 304523804
• Report Number: 8010047-2022-11573
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2022

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: OER-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 07/12/2022; 09/01/2022
• Supplement Dates FDA Received: 08/10/2022; 09/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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