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

Model Number	OTV-S7H-1D-F08E
Medical Device Problem Codes	Corroded (1131); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed that during the device evaluation, that the subject device exhibited electrical contact corrosion and main body flooding.There was no patient involvement.
Additional Manufacturer Narrative
The device was returned to olympus for inspection.A root cause could not be identified.Based on the results of the investigation, for electrical contact corrosion and for scope mound corrosion events, it is presumed that this occurred due to the deterioration of the metal in the contact area over a long period of use, due to corrosion in the contact area.For main body flooding event the cause of the occurrence could not be identified a review of the device history record found no deviations that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• 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: 20863551
• Report Number: 3002808148-2024-38356
• Device Sequence Number: 8785909
• Product Code: FET
• UDI-Device Identifier: 04953170142246
• UDI-Public: 04953170142246
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2024

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: Other
• Device Model Number: OTV-S7H-1D-F08E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2015
• 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