MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. RHINO-LARYNGO VIDEOSCOPE

Model Number ENF-VH

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated by olympus.In addition to the findings, evaluation found the watertightness of the insertion tube was not maintained, the flexible tube of the insertion section was crushed, the insertion tube was discolored due to insufficient cleaning, the bending angle was insufficient due to the elongation of the angle wire, the curved rubber adhesive as missing, the video cable was crushed, the manufacturing label of the light guide connector part came off, and scratches were found on multiple parts of the scope.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported that there was a problem with the coating of the insertion section of the rhino-laryngo videoscope.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found insertion tube was detached.The report is being submitted due to insertion tube being detached found during evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information obtained from the customer.This event is under investigation.The supplemental report will be submitted upon completion of the investigation.

Event Description

Additional information received from the customer reported the insertion coating failure was found prior to a procedure.There was no delay to the procedure and the patient was not under general anesthesia or sedation.The scope was not used for a procedure.

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 to the reported issue.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the insertion bending tube detached due to stress or user handling.The root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: RHINO-LARYNGO VIDEOSCOPE
• Type of Device: RHINO-LARYNGO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15643381
• MDR Text Key: 307065734
• Report Number: 3002808148-2022-03406
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04953170310447
• UDI-Public: 04953170310447
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K221638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2022

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 Operator: Health Professional
• Device Model Number: ENF-VH
• Device Catalogue Number: N3828330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/20/2022
• Supplement Dates Manufacturer Received: 10/26/2022; 11/11/2022
• Supplement Dates FDA Received: 11/10/2022; 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1