MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ORBEYE LED LIGHT SOURCE; OPERATION MICROSCOPE

Model Number OME-L200

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

During the pancreaticoduodenectomy with the orbeye surgical microscope ome-v200, led light source ome-l200 and foot switch maj-2301, a microscope error e116, e117 appeared and the autofocus and electric zoom of the microscope did not work.The user completed the procedure by manually adjusting the zoom and focus.The procedure time longer than planned due to this problem.The microscope was used to assist in suturing and to share the surgical field with surgical staff.Other detailed information was not provided.There was no report of patient injury associated with the event.This is a report for ome-l200.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc confirmed the device, and there was no abnormality of the device.Based on the results of the investigation, the reported phenomenon was occurred due to the ome-v200.

• Brand Name: ORBEYE LED LIGHT SOURCE
• Type of Device: OPERATION MICROSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11330465
• MDR Text Key: 233372813
• Report Number: 8010047-2021-02642
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K190772
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OME-L200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/15/2021
• Supplement Dates Manufacturer Received: 04/09/2021
• Supplement Dates FDA Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1