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

Model Number	OTV-S7H-NA-12E
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection and the reported failure was confirmed.In addition, the following reportable malfunctions were identified during the device evaluation: water ingress into the video connector, water immersion in the camera cable, and broken wire and a flaw (hole) in the camera cable.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: based on the results of the investigation, it is likely that the following led to the customer's issue: the image capture system has a malfunction that prevents normal communication, and this was likely to be the cause of the image noise.The camera head was not airtight, and moisture entered the interior, likely resulting in failure of the main unit's imaging due to moisture.Based on the results of the investigation, it is likely that the following led to the malfunctions identified during the device evaluation: because the video connector was cracked, the airtightness could not be maintained, and moisture had penetrated into the inside of the connector, leading to flooding of the video connector.The camera cable had a flaw (hole), which prevented it from being airtight, allowing moisture to enter the interior, likely resulting in flooding of the camera cable.A definitive root cause cannot be identified for broken wire in the camera cable.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 reported that during preparation for use for an unspecified therapeutic procedure, the subject device had a poor image quality.The procedure was completed using a similar device with no surgical delay.There were no reports of patient harm.

• 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: 19693059
• Report Number: 3002808148-2024-34604
• Device Sequence Number: 8122490
• Product Code: FET
• UDI-Device Identifier: 04953170141867
• UDI-Public: 04953170141867
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/08/2024

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: Health Professional
• Device Model Number: OTV-S7H-NA-12E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 07/08/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown