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

Model Number	OTV-S7H-1NA-10E
Medical Device Problem Codes	Break (1069); Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Reported event: image flickering due to camera head cable damage no death, injury or harm was reported to olympus.There was no patient or procedure involvement.No product return to olympus.This is a service log type of inquiry.Note: based on product complaint form, the product model is otv-s7-h10, but the product model could not be found both in the item code list and global complaint handling system (gchs).So product is selected as "unknown" and the option with mla in the dropdown according to triage process guideline.
Additional Manufacturer Narrative
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 the camera head had image flickered and the cable damage.The issue was found during set up.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide correction in the field b5.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 report is being submitted to provide the results of the final investigation.Updated fields: d8, h2, h6, h11.The device was not returned to olympus for inspection and the reported failure was not confirmed.Therefore, a definitive root cause could not be determined.Based on historical data, possible causes include electrical problems due to open or short circuit, signal loss, and mechanical issues such as leakage/seal, damage, deterioration, and wear and tear between components such as connector/coupler; adapter; switch/relay; circuit board; electrical cable; sensor; lenses; seal without any design or manufacturing issue.That could cause image issues.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
No additional information received from customer.

• Brand Name: AUTOCLAVABLE 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: 21980451
• Report Number: 3002808148-2025-07573
• Device Sequence Number: 21097615
• Product Code: GCJ
• UDI-Device Identifier: 04953170141836
• UDI-Public: 04953170141836
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

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-1NA-10E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 05/08/2025; 06/25/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 05/09/2025; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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