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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. 3DV-190 100V (JA) 3D VISUALIZATION UNIT Back to Search Results
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.

 
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Brand Name3DV-190 100V (JA)
Type of Device3D VISUALIZATION UNIT
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key7463507
MDR Text Key107193008
Report Number8010047-2018-00758
Device Sequence Number0
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK123365
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/15/2019
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received04/26/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3DV-190
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/20/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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