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

Model Number ENF-VH

Device Problem Loss of or Failure to Bond (1068)

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

Event Type  malfunction  

Event Description

A user facility returned to olympus the olympus, model enf-vh, rhino-laryngo videoscope for repair due to a report of an "air/water leak." there was no patient injury, associated with the problem, reported to olympus.Upon inspection and testing of the returned device, it was found that the insertion tube resin fell off.This report is submitted due to the finding that the insertion tube resin fell off, identified during in-house service of the device.As the problem was found during in-house service of the device, there was no patient involvement.

Manufacturer Narrative

The device was evaluated by olympus.The evaluation found that the insertion tube resin fell off due to chemical and/or physical stress.Additional evaluation findings are as follows: 1.) water tightness not maintained due to falling off of the insertion tube due to external factors.2.) the water tightness of the curved rubber bond is not maintained.3.) insertion tube serpentine falling off; 4.) the insertion tube noted discolored due to handling (insufficient cleaning); 5.) scratches on the insertion tube noted due to external factors; 6.) wrinkles in the insertion tube noted due to external factors; 7.) the curved tube is noted crushed due to external factors; 8.) the bending angle was determined insufficient due to the elongation of the angle wire; 9.) liquid leakage found in the light guide bundle due to handling; 10.) light guide bundle defect due to external factors; 11.) scratches were found on the operation part due to external factors; 12.) corrosion due to water leakage noted; 13.) the curved rubber adhesive was noted missing; 14.) the insertion tube was noted broken due to an external factor; 15.) scratches were found on the switch box due to external factors; 16.) liquid leakage was noted in the grip part due to handling; 17.) scratches were found on the grip due to external factors; 18.) liquid leakage was noted on the up/down plate; 19.) liquid leakage noted in the universal cord; 20.) the universal code was observed collapsed due to external factors; 21.) scratches are found on the universal cord due to external factors; 22.) wrinkles were observed in the universal cord due to external factors; 23.) scratches were found on the video cable due to external factors; 24.) the video cable was noted broken due to an external factor; 25.) the video connector has been damaged by an external factor; 26.) scratches were noted on the angle lever due to external factors; 27.) scratches were found on the light guide connector due to external factors; 28.) scratches were found on the video connector case due to external factors; 29.) scratches were noted on the up/down angle fixing lever due to external factors; 30.) the manufacturing label of the light guide connector part has come off.The investigation is ongoing and the definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

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 (dhr) found no deviations that could have caused or contributed to the reported event.Dhr confirmed that the subject device was shipped in accordance with the specifications.A definitive root cause for this issue was not established.However, it is probable that the device was damaged during normal use and/or reprocessing.The causes of these failures were not determined.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 (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15810272
• MDR Text Key: 307567268
• Report Number: 3002808148-2022-04265
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04953170411403
• UDI-Public: 04953170411403
• 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
• Report Date: 01/05/2023

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: N6006840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 12/08/2022
• Supplement Dates FDA Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2016
• 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