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

Model Number OER-3

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problems Nausea (1970); Malaise (2359); No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

The subject oer-3 has not return to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If significant additional information is received, this report will be supplemented.

Event Description

A staff of facility became feel sick due to smell of disinfectant solution (acecide) from oer-3.A staff of facility recovered after a few hours of rest.There was no report other than above.

Manufacturer Narrative

The subject oer-3 was returned to olympus medical systems corp.(omsc) for evaluation.Omsc evaluated the subject oer-3 and found that it had no abnormality.Omsc checked the device history record of the subject oer-3, and there was no irregularity found.When checking the log data of the subject oer-3, a record indicating that the power was turned off under a condition where the disinfectant bottle drawer was pulled out could be confirmed multiple times.If the disinfectant bottle drawer remained pulled out, the smell of disinfectant solution would leak outside the device without passing through the gas filter, therefore the smell of disinfectant solution may have been temporarily strong.After checking the ventilation environment in the user facility, it was confirmed that the ventilation duct, which seemed to be used for the subject oer-3, was placed away from the location of the gas filter on the subject oer-3¿s lid.Thus, the ventilation capacity may have been affected.Because sensitivity to a smell varies between individuals, the exact cause of the reported event could not be conclusively determined at this time.Oer-3 instruction manual states the notice for the ensuring the safety of reprocessing personnel.

• Brand Name: OER-3 100V
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7528681
• MDR Text Key: 108722031
• Report Number: 8010047-2018-00893
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: OER-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/20/2018
• Supplement Dates Manufacturer Received: 05/29/2018
• Supplement Dates FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other