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

Model Number	OTV-S7H-1D-L08E
Medical Device Problem Codes	Break (1069); No Display/Image (1183); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the camera head image did not display, the connector was cracked, and the cable had water intrusion.There were no reports of patient harm.
Additional Manufacturer Narrative
E2/e3: no information available for the occupation of the initial reporter or whether they are a healthcare professional.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that the image on the subject device did not display.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device was returned to olympus for inspection and the customer¿s allegation could not be confirmed.Therefore, the cause of the failure could not be determined.Although the customer reported failure could not be confirmed, based on historical data, possible causes include electrical problems due to open or short circuit, material degradation, and mechanical issues such as leakage/seal, deformation, fatigue, and wear and tear between the camera head components without any design or manufacturing defects.In addition, the device evaluation found a cracked connector and water intrusion in the cable and camera unit.The most likely failure of the cracked connector and water intrusion was attributed to component failure.However, its unknown what caused the components to fail.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This supplemental emdr is being submitted to correct the manufacturing date: h4.
Event or Problem Description
It was reported that the image on the subject device did not display.There were no reports of patient harm.

• 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: 20642707
• Report Number: 3002808148-2024-37648
• Device Sequence Number: 20674383
• Product Code: FET
• UDI-Device Identifier: 04953170323584
• UDI-Public: 04953170323584
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2025

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: Health Professional
• Device Model Number: OTV-S7H-1D-L08E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 11/21/2024; 04/11/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/21/2024; 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2009
• 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