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

Model Number OER-4

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

The subject oer-4 will not be returned to olympus.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

The user felt electrical stimulation when the user touched the lid of the subject oer-4 and the water faucet simultaneously.There was no report of the user¿s injury regarding this event.The field service engineer reported the following check result.The electrical outlet of the facility is not a hospital-grade.The facility used the conversion adaptor to change the shape of the power plug of the subject oer-4.The ground wire of the conversion adaptor was out of the ground terminal of the electrical outlet of the facility.The ground wire entered into the gap of the conversion adaptor.The electrical current flowed to the subject oer-4.

Manufacturer Narrative

The subject oer-4 was not returned to olympus medical systems corp.(omsc) for evaluation, omsc could not evaluate the subject oer-4.Omsc checked the device history record of the subject oer-4, there was no irregularity found.The facility is continuing to use the subject oer-4, therefore omsc surmised the subject oer-4 had no malfunction.The exact cause of the reported event could not be conclusively determined, however there is possibility of this phenomenon is attributed to the following.The improper connection of the power supply produced an electrical potential difference between the subject oer-4 and the water faucet, and an electrical current flowed to the user when the user touched the subject oer-4 and the water faucet simultaneously.The instruction manual states the proper installation method of the oer-4.

• Brand Name: OER-4 100V
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8058996
• MDR Text Key: 129160180
• Report Number: 8010047-2018-02171
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• 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
• Date Manufacturer Received: 12/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1