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

Model Number	OTV-S7H-1D
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 the subject device's image was blurred.The issue occurred at the beginning of a therapeutic and diagnostic cystoscopy procedure.The procedure was completed using a similar device with no surgical delay.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.Updated fields: d8, d9, h2, h3, h6, h11 the device was returned to the regional repair center for inspection and the reported failure was confirmed.In addition, the following reportable malfunctions were identified during the device evaluation: plug unit is deteriorated, image definition is not usual, water tightness is lost, color tone of the image is not proper.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: regarding the customer¿s allegation, the camera was visually altered due to a non-specific cause.The plug unit was deteriorated for an unspecified reason.The image definition was unusual due to damage to the camera unit.The watertightness was lost due to poor watertightness of the cable unit, and the color tone of the image was improper due to damage to the cable unit." 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: 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: 20480621
• Report Number: 3002808148-2024-37308
• Device Sequence Number: 8324295
• Product Code: GCJ
• UDI-Device Identifier: 04953170141645
• UDI-Public: 04953170141645
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 01/06/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2015
• 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