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

Model Number CH-S400-XZ-EB

Device Problems Erratic or Intermittent Display (1182); Poor Quality Image (1408)

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

Event Type  malfunction  

Event Description

It was reported that, the subject device image flashes, and sometimes the colorful strips.The issue occurred during preparation for use and the laparoscopic surgery therapeutic procedure was completed using the same set of equipment.There were no reports of patient harm.

Manufacturer Narrative

The subject device underwent visual and functional inspection and the reported allegation was confirmed.The image blinks and color bars occurred.Additionally, the device evaluation found a failure of the camera cable and error message e222.Since there was a failure of the camera cable, the internal coupled charged device may have failed.Therefore, it is presumed that normal communication is not possible, resulting in the sometimes blinking images and color bars reported, as well as error e222.Based on the results of the investigation, a definitive root cause cannot be identified.A device history review revealed no issues that could have caused or contributed to the reported issue.This issue is addressed in the instructions for use (ifu): " precautions for disappeared or frozen endoscopic image.Important information ¿ please read 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 according to section 5.3, ¿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].Do not use excessive force when wiping the external surfaces of the camera cable.Otherwise, the camera cable could become damaged." "otv-s400 instruction manual·code:e222 error message: camera head communication error.Possible cause: the communication between the endoscope and video system center has failed.Solution: immediately turn the video system center off and disconnect the video connector.Clean the electrical contacts of the video connector and connect again.If the same problem occurs after turning the video system center on again, immediately turn the video system center off, and unplug the power cord from the wall mains outlet and the ac power inlet on the video system center, then contact olympus." olympus will continue to monitor the field performance of this device.".

• 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: 18970391
• MDR Text Key: 339329166
• Report Number: 3002808148-2024-31645
• Device Sequence Number: 1
• Product Code: FET
• UDI-Device Identifier: 04953170374609
• UDI-Public: 04953170374609
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K172817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2019
• 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
• Treatment: CLV-S400(N5401560); OTV-S400 (7932982); WA03310A(WA03310A); WA4KL130(WA4KL130)