MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIDEO SYSTEM; VIDEO SYSTEM CENTER

Model Number	OTV-SC
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 the evaluation.Olympus repair center could reproduce the reported phenomenon and found the device didn't have a malfunction.The exact cause of the reported event could not be conclusively determined.Omsc surmised from the evaluation by olympus repair center that this phenomenon attributed to a malfunction of the camera head.If additional information becomes available, this report will be supplemented.
Event or Problem Description
During the preparation for use, the endoscopic image was not displayed.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.

• Brand Name: VIDEO SYSTEM
• Common Device Name: VIDEO SYSTEM CENTER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11190932
• Report Number: 8010047-2021-01590
• Device Sequence Number: 19893245
• Product Code: GCJ
• UDI-Device Identifier: 04953170136894
• UDI-Public: 04953170136894
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K955404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/19/2021

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: OTV-SC
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 01/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1