MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-5 100V; ENDOSCOPE REPROCESSOR

Model Number OER-5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Headache (1880)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

From may 29, 2020, the user facility introduced and started using the olympus endoscope reprocessor (oer-4; 1 unit, oer-5; 2 units).From (b)(6), the three reprocess staffs and one physician worked on the week day at the facility and they pleaded headache after returning home every day.They recovered at the weekend.They did not get medical attention.No error had occurred in the subject devices.They wore surgical masks before (b)(6), but after (b)(6) they switched to n-95 masks and no longer felt headaches.The user facility did not provide other detailed information.According to the number of patients and the number of olympus devices, olympus medical systems corp.(omsc) is submitting 12 medical device reports.This is 5 of 12 reports.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device in this report has not been returned to omsc for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.A causal relationship between the reported headache and 6% acecide disinfectant could not be excluded.As described in "ensuring the safety of reprocessing personnel" in the operation manual for oer-4 and oer-5, the disinfectant vapor generated by this device has been proven safe in in-house testing.Nevertheless, as individual reactions to the disinfectant may vary, olympus recommends the use of gas filters and enhanced protection by observing the ventilation conditions given in "ensuring the safety of reprocessing personnel".If additional information becomes available, this report will be supplemented.

• Brand Name: OER-5 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: 10232031
• MDR Text Key: 204013303
• Report Number: 8010047-2020-03912
• 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 faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OER-5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other