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

Model Number	OTV-S7H-NA-10E
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The repair center conducted visual and functional inspection on the subject device.The scope mount was determined not to meet the product specifications due to rattling.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.The dhr confirmed that the subject device was shipped in accordance with the specifications.Based on the investigation, no nonconformances were found.A definitive root cause cannot be identified.To mitigate risk/harm to the patient and damage to the device, the instructions for use provides the following: "preparation and inspection_inspection of camera head".Check that there is no looseness or rattling of the free lock lever when the free lock lever is lightly held and lightly rotated counterclockwise.Check that there is no looseness or rattling in the scope mount when the scope mount is operated.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was observed that during the device evaluation, the subject device's coupler was found to be loose.There was no report of patient involvement.

• 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: 18888088
• Report Number: 3002808148-2024-31351
• Device Sequence Number: 7605054
• Product Code: FET
• UDI-Device Identifier: 04953170141805
• UDI-Public: 4953170141805
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K043275
• 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): 03/12/2024

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-NA-10E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2013
• 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