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

Model Number CH-S400-XZ-EA

Device Problem Erratic or Intermittent Display (1182)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and the evaluation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.

Event Description

It was reported, the camera head had a flicker of noise on the monitor.The issue occurred during the procedure.There were no reports of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields: g3, h2, h3, h4, h6, h10 a review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus for inspection and the reported issue was confirmed.Device evaluation found cable failure resulted in noise in image and image defect (color bar).Additionally, cracks in connectors , main body wear were noted.Based on investigation findings, it is presumed that the cable failure caused the communication failure, resulting in image noise and image defects color bar.However, a definitive root cause could not be identified.Olympus will continue to monitor field performance for this device.

Event Description

It was reported, the camera head had a flicker of noise on the monitor.The issue occurred during the procedure.There were no reports of patient harm.

• Brand Name: 4K AUTOCLAVABLE CAMERA HEAD
• Type of Device: AUTOCLAVABLE 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: 18965396
• MDR Text Key: 338773129
• Report Number: 3002808148-2024-31633
• Device Sequence Number: 1
• Product Code: FET
• UDI-Device Identifier: 04953170375552
• UDI-Public: 04953170375552
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CH-S400-XZ-EA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• 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: OTV-S400.