MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-3 100V; ENDOSCOPE REPROCESSOR

Model Number OER-3

Device Problem Leak/Splash (1354)

Patient Problems Eye Injury (1845); Inflammation (1932); Irritation (1941)

Event Date 07/04/2019

Event Type  malfunction  

Manufacturer Narrative

The subject oer-3 has not been returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

When the user tried to install the cassette bottles of disinfectant solution in the oer-3, all disinfectant solution leaked inside the oer-3.The disinfectant solution vapor was emitted from the oer-3 and the user felt eye irritation.The user did not wear protective equipment like safety glasses at that time.The user saw an ophthalmologist and was diagnosed with eye inflammation, receiving eye-drop treatment.An olympus regional service engineer assumes the reason of the leak of the disinfectant solution was incomplete connection between the cassette bottles and the oer-3 that was caused by the user who was trying to install the cassette bottles, but failing to firmly press the disinfectant bottle drawer into the oer-3.There was no report other than above.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2019-02864.Olympus medical systems corp.(omsc) could not investigate the subject oer-3 because the subject oer-3 was not returned to omsc.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.Since the subject device was not returned, the exact cause was not determined; however, the following are potential cause of the reported event.The user did press the disinfectant bottle drawer firmly into the subject device.The function to lock the disinfectant bottle of the subject device was insufficient temporarily.There were no further details provided.If significant additional information is received, this report will be supplemented.The instruction manual provide warnings the device.Warning: when handling the disinfectant solution, wear appropriate personal protective equipment to prevent it from making direct contact with your skin and to prevent excessive inhalation of the vapor.The disinfectant solution and its vapor may adversely affect the human body.If you get disinfectant solution in your eyes, immediately rinse with a large quantity of water and then call the doctor.Personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed.All personal protective equipment should be inspected before use and replaced periodically before it is damaged.

• Brand Name: OER-3 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: 8867880
• MDR Text Key: 204282403
• Report Number: 8010047-2019-02864
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: OER-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2009
• 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