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

Model Number OER-PRO

Device Problem Fluid/Blood Leak (1250)

Patient Problems Headache (1880); Dizziness (2194)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

A field service engineer has been dispatched to the facility to evaluate and repair the device.The cause of the reported event cannot be determined.If additional information becomes available at a later time, this report will be supplemented.This event has been reported by the (b)(4).

Event Description

It was reported the front port of the unit was leaking and all the acecide spilled onto the floor.As a result, one of the operators experienced headache and dizziness from the smell.The operator was removed from the contaminated area.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.The area was cleaned with copious amounts of water as advised.The operator had no further complaints after the area was cleaned, and her headache and dizziness resolved.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.A material safety data sheet (msds) was sent to the customer and a field service engineer as been dispatched to replace the front port of the unit.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and device history record (dhr) review.Updates to sections h4 and h6.The dhr for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.A conclusive root cause was not identified.The legal manufacturer determined that acecide may have leaked due to a loose disinfectant removal port.The disinfectant removal port was likely loosened due to attachment/detachment of the disinfectant removal tube and/or drain connector from the disinfectant removal port.

• 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: 10289144
• MDR Text Key: 205720564
• Report Number: 8010047-2020-04525
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-PRO
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other