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

Model Number	OTV-S7H-1D
Medical Device Problem Codes	Corroded (1131); Leak/Splash (1354); Loose or Intermittent Connection (1371); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection and the following reportable malfunctions were identified during the device evaluation: poor scope mount connection, image noise, corrosion on the video connector electrical contacts, watertightness failure in a switch, and water intrusion in the imaging of the main unit.Based on the results of the investigation, it is likely the following led to the malfunction: a root cause could not be identified for poor scope mount connection, corrosion on the video connector electrical contacts, and water intrusion in the imaging of the main unit.It is presumed that the switch has a watertight failure due switch 1 was damaged.Because there is flooding in the main unit imaging, there is a possibility that the internal charged coupled device has reached failure.Therefore, it is presumed that normal communication is not possible, leading to the generation of image noise.Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was observed that during the device evaluation, the subject device exhibited a poor scope mount connection, image noise, corrosion on the video connector electrical contacts, watertightness failure in a switch, and water intrusion in the imaging of the main unit.There was no patient involvement.

• 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: 20247777
• Report Number: 3002808148-2024-36513
• Device Sequence Number: 20641752
• Product Code: GCJ
• UDI-Device Identifier: 04953170141645
• UDI-Public: 04953170141645
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2024

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: OTV-S7H-1D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2009
• 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