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

Model Number	OTV-S7PROH-HD-L08E
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the device manufacturing date.\ \ updated fields: h2, h4, h11.\ \ 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
Date of event is unknown.Additional information will be provided if available.\ \ the final investigation has been completed.\ \ based on the final investigation of the device, failure identified during the inspection have been confirmed.\ \ a root cause could not be identified.Based on the results of the investigation, the most probable cause of the malfunction was traced to component failure.\ \ 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
The customer returned the camera head, which is an olympus asset with no reported complaint.During the initial evaluation of the returned device, a failed leak test was observed.There was no patient involvement.
Event or Problem Description
No additional information received from the customer.

• Brand Name: HD 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 ; +1(508)207-7661
• MDR Report Key: 50885327
• Report Number: 3002808148-2026-33661
• Device Sequence Number: 15893314
• Product Code: FET
• UDI-Device Identifier: 04953170268267
• UDI-Public: 04953170268267
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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-S7PROH-HD-L08E
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/17/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown