MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HD 3CMOS CAMERA HEAD

Model Number CH-S200-XZ-EB

Device Problems Electrical /Electronic Property Problem (1198); Moisture Damage (1405)

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

Event Type  malfunction  

Manufacturer Narrative

The asset device was returned to olympus.And the customer's allegation was confirmed.In addition to the findings reported in b5.The focus ring was deformed.The investigation is ongoing.Therefore, the root cause of the device problem cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported to olympus, that there was an air leak coming from the main unit.During evaluation of the returned device, the image was cloudy; due to charge coupled device water fog (moisture intrusion due to water-tight break).This medical device report (mdr) is being submitted to capture the reportable malfunctions found during incoming inspection and evaluation.There were no reports of patient harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, it was determined that the image got cloudy due to flooding inside of the charge-coupled device (ccd).A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.The instruction manual identifies the following related verbiage which could have prevented the phenomenon: ¿never bash or drop this camera head.This could allow water to penetrate and damage electrical circuits inside the camera head.¿ olympus will continue to monitor field performance for this device.

• Brand Name: HD 3CMOS CAMERA HEAD
• Type of Device: CAMERA HEAD
• 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: 16924943
• MDR Text Key: 315210877
• Report Number: 3002808148-2023-04823
• Device Sequence Number: 1
• Product Code: FET
• UDI-Device Identifier: 04953170379611
• UDI-Public: 04953170379611
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200542
• 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: 06/12/2023

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: CH-S200-XZ-EB
• 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: 05/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2017
• 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