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

Model Number OER-6

Device Problem Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to olympus for evaluation.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported to olympus, the number of the number of uses and the number of days on the olympus endoscope reprocessor were not exchanged accurately.It was also noted, error e99 was suspected to have occurred.There was no harm or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was not returned; therefore, the reported phenomenon or condition of the device could not be confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It was confirmed that the device was shipped according to the specifications.It has been over 1 year since the subject device was manufactured.The specific root cause of the reported problem could not be determined at this time because the device was not returned.The following information is stated in the instructions for use (ifu): ¿3.11 checking the disinfectant solution concentration level when reprocessing an endoscope, always use an aceside 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.

• Brand Name: OLYMPUS 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: 14991739
• MDR Text Key: 302936272
• Report Number: 8010047-2022-11778
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-6
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2022
• Date Device Manufactured: 02/09/2021
• 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