MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SDI CABLE 2.5M

Model Number	MAJ-1951
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted to report the user's experience and the investigation findings.The device referenced in this report has not been returned to olympus for evaluation, therefore a physical evaluation of the complaint device could not be conducted.The device history record (dhr) for the complaint device could not be reviewed since the lot number was not provided.Olympus does not ship any device that does not meet all design and safety specifications.Conclusion: the definitive root cause of the reported event could not be determined.Based on the available information the following are presumed to be possible causes of the reported event: it is presumed that the cause was a short of the sdi cable due to aging caused by long-term use.
Event or Problem Description
It is reported during an unspecified procedure using a sdi cable 2.5m, the cable was bad causing the entire screen to go black.The cable was replaced and the issue was resolved.There was no patient impact related to this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the legal manufacturer's investigation, although a definitive root cause could not be determined, the probable cause is likely disconnection of the serial digital interface (sdi) cable due to aging caused by long-term use.

• Brand Name: SDI CABLE 2.5M
• 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
• MDR Report Key: 11455957
• Report Number: 8010047-2021-03549
• Device Sequence Number: 3191107
• Product Code: NWB
• UDI-Device Identifier: 04953170305047
• UDI-Public: 04953170305047
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K062049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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-1951
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1