MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-5 100V; ENDOSCOPE REPROCESSOR

Model Number OER-5

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Since the subject device has not been returned to omsc for the evaluation, the exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that the lid of the subject device was cracked at the unspecified timing.At the incoming inspection for the repair, olympus service operation repair center (sorc) checked the subject device and identified the reported phenomenon.There was no patient injury associated with this report.It was not provided the other detailed information.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Since the subject device was not returned to olympus medical systems corp.(omsc), it could not be investigated.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However based on the report of olympus service operation repair center (sorc), omsc surmised there was the possibility this phenomenon was attributed to followings; some object was dropped on the lid of the subject device.Excessive repeatedly stress was applied to the lid because the user closed the lid with excessive force.The solvent crack occurred due to the mechanical stress while the closing the lid and the remaining the chemical agent such as detergent solution on the lid.Some other factors.If additional information becomes available, this report will be supplemented.

• Brand Name: OER-5 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
• MDR Report Key: 10441996
• MDR Text Key: 204089761
• Report Number: 8010047-2020-05759
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: OER-5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1