MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SDI CABLE 8.5M

Model Number	MAJ-1912
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The referenced cable was returned to the service center without the original packaging or esd (electro static discharge) bag; therefore, the lot number is unknown.A visual inspection of the cable was performed and found a large scrape and scratches on the cable.Both connectors passed the continuity check.The sdi cable was then connected to olympus test video system center (cv-190) and monitor (oev-261h); the sdi signal was present and color image was normal, no flickering or intermittent signal was observed; the reported malfunction of intermittent issue could not be confirmed.The original equipment manufacturer (oem) was unable to perform a review of the device history records.However, based on the physical evaluation results, the reported event could not be confirmed; therefore, the oem determined there was a problem with the connected device or connection status.Also, it is speculated that the large scrape marks and scratches on the cable were mistakenly placed at installation.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: properly and securely connect all cables.If the cable connector has connection screws, tighten up the screws.Otherwise, equipment damage or malfunction can result.
Event or Problem Description
During receipt inspection/unboxing, the sdi (serial digital interface) cable was found to have an intermittent signal.No patient involvement was reported.
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.Correction to g3 of the initial medwatch.The aware date should be 04-sep-2020.Olympus will continue to monitor the field performance of this device.

• Brand Name: SDI CABLE 8.5M
• Common Device Name: SDI CABLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11153772
• Report Number: 8010047-2021-01229
• Device Sequence Number: 2564509
• Product Code: FDF
• UDI-Device Identifier: 04953170304866
• UDI-Public: 04953170304866
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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: MAJ-1912
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 10/02/2022
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 10/12/2022
• 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