MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. 3G-SDI CABLE 8.5M

Model Number	MAJ-2016
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus medical systems corp.(omsc), but returned to olympus repair center for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If significant additional information is received, this report will be supplemented.
Event or Problem Description
The device (maj-2016) was laid on the floor and wired between the video system center and the monitor.During the preparation for use, the user found that the endoscopic image on the monitor became a blackout.The user rewired to prevent the device cable from touching the floor and the problem was resolved.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) investigated the device.However, omsc could not reproduce the reported phenomenon.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of the reported event could not be conclusively determined.Omsc surmised that this phenomenon attributed to the following.-a partial disconnection of the cable was cut off.-aging deterioration may have caused the defect because 7 years have passed since the device was manufactured.If significant additional information is received, this report will be supplemented.

• Brand Name: 3G-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
• MDR Report Key: 11989308
• Report Number: 8010047-2021-07451
• Device Sequence Number: 10978021
• Product Code: FGB
• UDI-Device Identifier: 04953170338250
• UDI-Public: 04953170338250
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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: No Information
• Device Model Number: MAJ-2016
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1