MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. 12G-SDI CABLE 8.5M

Model Number	MAJ-2429
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A field service engineer reported on behalf of the customer, that the serial digital interface (sdi) cable was producing image noise.The issue was found during preparation for use.There were no reports of patient harm.
Additional Manufacturer Narrative
Although the device was not returned for evaluation, an olympus field service engineer (fse) went onsite and confirmed the reported issue.The fse changed the cable out and there were no further issues.However, as the device was not returned to olympus for evaluation, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: 12G-SDI CABLE 8.5M
• Common Device Name: SDI CABLE
• 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: 20818927
• Report Number: 3002808148-2024-11205
• Device Sequence Number: 7804047
• Product Code: FET
• UDI-Device Identifier: 04953170415630
• UDI-Public: 04953170415630
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K222861
• 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,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 12/02/2024

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: MAJ-2429
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 12/02/2024
• 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