MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. 3DV-190 100V (JA); 3D VISUALIZATION UNIT

Model Number 3DV-190

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

The referenced 3dv-190 was not returned to olympus medical systems corp.(omsc) for evaluation, therefore omsc cannot evaluate the 3dv-190.Omsc checked the manufacture history of the 3dv-190, there was no irregularity found.The facility was continuing to use the referenced 3dv-190, therefore the 3dv-190 had no malfunction.The exact cause of the reported event could not be conclusively determined, however there is the possibility of this phenomenon is attributed to the following.A temporary abnormality occurred in the power source of the facility.The plug of the extension cord was incompletely connected to the wall outlet of the facility, then the foreign material or dust and so on adhered between the terminals of the plug.Consequently the short circuit occurred at the plug.Because the power consumption of the instruments which connected to the extension cord exceeded the rating of the extension cord, the extension cord broke.Therefore, there is the possibility of this phenomenon is attributed to the inappropriate handling by the user.Olympus stated the appropriate handling of 3dv-190 and the counter measures against abnormalities in the instruction manual of 3dv-190.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Olympus was informed following.The facility used the imaging system (including the 3dv-190) which was plugged into the wall outlet of the facility via the extension cord.During the laparoscopic local resection of stomach, the referenced wall outlet of the facility was short-circuited then the power of the imaging system became shut-down.The facility changed the imaging system to the other unspecified similar imaging system and the procedure was completed.There was no report of the patient¿s injury regarding this event.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• Brand Name: 3DV-190 100V (JA)
• Type of Device: 3D VISUALIZATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7463507
• MDR Text Key: 107193008
• Report Number: 8010047-2018-00758
• Device Sequence Number: 1
• Product Code: FET
• Combination Product (y/n): N
• PMA/PMN Number: PK123365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/15/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3DV-190
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1