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

Model Number	MAJ-554
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed during device evaluation that the camera cable was flooded.There was no patient involvement.
Additional Manufacturer Narrative
E3: non-health care professional; e2-no.The camera cable sheath was peeled off, indicating that the camera cable could no longer be kept watertight.There was moisture ingress, which led to the flooding.A device history review could not be verified since the equipment in question was manufactured more than 15 years ago.This issue is addressed in the instructions for use (ifu): check that there are no cracks, burrs, or other abnormalities on the exterior part of the camera head, and that there are no abnormal sags, bulges, scratches, or holes on the camera cable.Olympus will continue to monitor the field performance of this device.
Additional Manufacturer Narrative
This supplemental emdr is being submitted to correct the manufacturing date: h4.
Event or Problem Description
No additional information received from customer.

• Brand Name: CAMERA HEAD
• Common Device Name: 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: 19031828
• Report Number: 3002808148-2024-31883
• Device Sequence Number: 15500641
• Product Code: GCJ
• UDI-Device Identifier: 04953170136931
• UDI-Public: 04953170136931
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

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
• Operator of Device: Other
• Device Model Number: MAJ-554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown