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

Model Number ENF-V2

Device Problem Material Separation (1562)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found a cut on connecting tube, water tightness is lost.Part of connecting tube is fallen off.Paint on distal end is peeled.Bending section rubber has slack.Connecting tube has a dent.Due to damage on charged coupled device unit, the image has linear scratches.Video connector has a scratch.Light guide connector has a scratch.Light guide-cover glass has a scratch.Light guide-cover glass is dirty.Video cable is dirty.Video cable has a scratch.Universal cord has a scratch.Up/down plate has a scratch.Angulation lever has a scratch.Grip has a scratch.Switch box has a scratch.Control unit has a scratch.Image guide protector has a scratch.Connecting tube has a dent.Video connector case has a scratch.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 13 years since the subject device was manufactured. the equipment was shipped in compliance with specifications.Based on the results of the investigation, the likely cause is determined to be due to mishandling at the facility.A definitive root cause cannot be identified.This issue is addressed in the instructions for use (ifu): do not apply impact or excessive force to the scope insertion part with metal or sharp-tipped instruments.Doing so may damage the endoscope.Do not twist or bend the bending section with your hands.Equipment damage may result.There is a possibility that unrecognized damage may be caused when a high impact strikes the distal end.Be sure to contact olympus for repair.Olympus will continue to monitor the field performance of this device.

Event Description

The customer reported to olympus that the visera rhino-laryngo videoscope had a perforation in the insertion tube.Inspection and testing of the returned device found that the resin part of the image guide coil was falling off.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

• Brand Name: VISERA 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16921422
• MDR Text Key: 315482484
• Report Number: 3002808148-2023-04803
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04953170291029
• UDI-Public: 04953170291029
• 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: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2010
• 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