MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. MEDICAL CONTROL UNIT FOR ENDOSURGERY; SYSTEM INTEGRATION

Model Number UCES-3

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/06/2017

Event Type  malfunction  

Manufacturer Narrative

The subject uces-3 was returned to olympus for evaluation.Olympus checked the subject uces-3, and there was no abnormality of the subject device.There were no further details provided at this time.If significant additional information is received, this report will be supplemented.

Event Description

During the unspecified laparoscopic surgery, the user facility could not operate devices, because an image of a main monitor and a sub monitor of the endoalpha system disappeared.The user facility replaced the subject system including uces-3 with another unspecified system to complete the procedure.There was no report of the patient injury other than replacing the device.When the subject system was checked after the procedure, there was no abnormality of the subject system.The user facility suspects the subject uces-3 which controls the 2 monitors to display images might have any abnormality.

Manufacturer Narrative

Omsc reviewed the log of the subject uces-3 of the event date, and no irregularities related the reported phenomenon was noted.Omsc investigated the internal of the subject uces-3, there was no abnormality found.The root cause of this event could not be conclusively determined, because the reported phenomenon was not reproduced.However, omsc surmised that the possible cause of this event was the following in theory.Any kind of the temporary malfunction of the mother board.Any kind of the temporary malfunction of the circuit board for image display.Any kind of the malfunction of the image signal output terminal.The uces-3 instruction manual states the corresponding method when there is an abnormality for the device.There were no further details provided.If significant additional information is received, this report will be supplemented.

• Brand Name: MEDICAL CONTROL UNIT FOR ENDOSURGERY
• Type of Device: SYSTEM INTEGRATION
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 8142642517
• MDR Report Key: 6288864
• MDR Text Key: 66442321
• Report Number: 8010047-2017-00100
• Device Sequence Number: 1
• Product Code: ODA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK102763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

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
• Device Operator: No Information
• Device Model Number: UCES-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2017
• Initial Date FDA Received: 01/31/2017
• Supplement Dates Manufacturer Received: 11/13/2017
• Supplement Dates FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1