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

Model Number OER-PRO

Device Problems Fluid/Blood Leak (1250); Device Emits Odor (1425)

Patient Problems Headache (1880); Dizziness (2194)

Event Date 06/24/2020

Event Type  Injury  

Event Description

It was reported that during reprocessing (1st wash cycle of the morning), the front port of the unit was leaking and all of the acecide spilled onto the floor.As a result, one of the operator's experienced headache and dizziness from the smell.The solution was cleaned up with a towel.The customer was advised to put the towel in a container and dispose of following local and national regulations.A material safety data sheet (msds) was sent to the customer and a field service engineer will be dispatched to replace the front port of the unit.The user reported the unit was inspected prior to washing the scope.No anomalies were seen.There were no other devices involved.Additional information is unavailable at this time.The cause of the reported event cannot be determined.If additional information becomes available at a later time, this report will be supplemented.

Event Description

This report is being supplemented to provide additional information regarding the reported event.Additional information received identified the employee was removed from the contaminated area.The area was cleaned with copious amounts of water.The employee had no further complaints after area was cleaned, and her headache and dizziness resolved.

• 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
• MDR Report Key: 10286116
• MDR Text Key: 203852930
• Report Number: 2951238-2020-00480
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/11/2020,08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-PRO
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other