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

Model Number MAJ-554

Device Problem Image Display Error/Artifact (1304)

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

Event Date 05/09/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, during preparation for a diagnostic procedure, the camera head had image problem.Subsequently, the intended procedure was completed with a similar device.There was no harm or user injury reported due to the event.

Manufacturer Narrative

The subject device has been returned to olympus for evaluation and the reported issue was confirmed.During evaluation, it was observed, glass was noted to be broken, the guide pun of the coupler was broken, and the fixing part of the coupler was loose.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the image issue was caused by a faulty head part.However, the definitive root cause of the faulty head part and broken glass could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: 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: 17062055
• MDR Text Key: 317638210
• Report Number: 3002808148-2023-05609
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170136931
• UDI-Public: 04953170136931
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K955404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2011
• 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: MODEL NUMBER: OTV-SC, NO SERIAL NUMBER