MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OME9-MB-I; OPERATION MICROSCOPE

Model Number OME9-MBI

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device was inspected at sorc.Sorc checked the subject device and found the reported phenomenon.The exact cause of the reported event could not be conclusively determined at this time.

Event Description

Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at olympus service operation repair center (sorc), it was found that the eyeshade had been cut.The occurrence date of the event is unknown.There was no report of patient injury associated with the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed the reported device problem.A definitive root cause for this issue was not established.However, it is probable that the issue occurred because of mishandling or repeated/long term use of the device.Since the eyeshade was also partially torn, it is presumed that the issue may have resulted from repeated actions such as partially pinching and pulling the eyeshade.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 10-oct-2021.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• Brand Name: OME9-MB-I
• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13073124
• MDR Text Key: 283774745
• Report Number: 8010047-2021-16713
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2022

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 Model Number: OME9-MBI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/26/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 08/10/2022; 11/08/2022
• Supplement Dates FDA Received: 08/18/2022; 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1