MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. 4K CAMERA HEAD

Model Number CH-S400-XZ-EB

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 02/23/2024

Event Type  malfunction  

Event Description

It was reported the camera head image was coming intermittently and turning off and the color bar was visible.The reported malfunction occurred during routine inspection by the customer.There were no reports of patient/user injury or harm.

Manufacturer Narrative

The subject device underwent visual and functional inspection and the allegation was confirmed.Images were displayed intermittently, and color bars and flickering occurred.Additionally, camera cable was broken and cable watertightness was defective.The camera cable was broken and the watertightness was defective, indicating that moisture may have penetrated inside the camera.Olympus assume that the charged coupled device inside the camera malfunctioned, which prevented normal communication and resulted in the image abnormality indicated.Based on the investigation, no nonconformances were found.A definitive root cause cannot be identified.A review of the device history record found no deviations that could have caused or contributed to the reported issue.To mitigate risk/harm to the patient and damage to the device, the instructions for use provides the following: precautions for disappeared or frozen endoscopic image before use[warning] ·if the endoscopic image disappears unexpectedly or the frozen image cannot be restored during an examination, immediately stop using the camera head and withdraw the endoscope from the patient, ¿withdrawal when any irregularity is observed¿.Continued use of the endoscope under this condition could result in patient injury, bleeding, and/or perforation.Reprocessing: general policy.[warning].·never clean, disinfect, or sterilize this equipment together with sharp-tipped instruments (tweezers, forceps, knives,etc.).These could scratch or tear holes in the camera cable,which could allow water to penetrate and damage electrical circuits inside the instrument.Olympus will continue to monitor the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported the camera head image was coming intermittently and turning off and the color bar was visible.The reported malfunction occurred during routine inspection by the customer.There were no reports of patient/user injury or harm.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the investigation.The device evaluation also found rust on the coupler.A definitive root cause cannot be identified.This issue is addressed in the instructions for use (ifu) preparation and inspection inspection of the camera head when turning the endoscope mount lock counterclockwise with holding it lightly, confirm that the endoscope mount lock is free from looseness or backlash.When operating the endoscope mount, confirm that the endoscope mount is free from looseness or backlash.

• Brand Name: 4K 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18952573
• MDR Text Key: 339240319
• Report Number: 3002808148-2024-31609
• Device Sequence Number: 1
• Product Code: FET
• UDI-Device Identifier: 04953170374609
• UDI-Public: 04953170374609
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K172817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CH-S400-XZ-EB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2019
• 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