MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA RHINO-LARYNGO VIDEOSCOPE

Model Number ENF-V2

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to omsc for evaluation but was returned to olympus service operation repair center (sorc).Sorc checked the subject device and found the reported phenomenon was not duplicated.The exact cause has been under investigation.Therefore, the exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user facility that in the unspecified timing, it was found that there was foreign material on the distal end of the subject device.There was no report of patient injury associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation but was returned to olympus service operation repair center (sorc).Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the information from sorc, omsc surmised that this phenomenon was attributed to the foreign material adhering to the distal end of the subject device due to the use of insufficient or improper reprocessing of the subject device.In addition, omsc confirmed that this phenomenon was not caused by product or manufacture, there were no safety problem, and there was no frequent occurrence.If additional information is received, this report will be supplemented.

• Brand Name: VISERA RHINO-LARYNGO VIDEOSCOPE
• Type of Device: RHINO-LARYNGO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12112941
• MDR Text Key: 280749481
• Report Number: 8010047-2021-08372
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ENF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1