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 Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report was not returned to olympus medical systems corp.(omsc) for evaluation, therefore omsc could not investigate the subject device.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 information from sorc, there was possibility that this phenomenon was attributed to the foreign object that had adhered to the bending section cover of the subject device and falling off from it.If additional information becomes available, this report will be supplemented.

Event Description

Olympus service operation repair center (sorc) was informed from the user facility that after the reprocessing of the subject device, it was found that the black foreign object came out from the subject device.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.Sorc checked the subject device and found that foreign object had adhered to the bending section cover of the subject device, and also found that there was trace of foreign object adhering to the bending section cover had fallen off from it.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10918159
• MDR Text Key: 226957837
• Report Number: 8010047-2020-09596
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ENF-V2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2013
• 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