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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA ¿ VIDEO SYSTEM CENTER

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA ¿ VIDEO SYSTEM CENTER Back to Search Results
Model Number CV-180
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Shock (2072); Numbness (2415)
Event Date 04/03/2019
Event Type  Injury  
Manufacturer Narrative

The device was not returned to olympus for evaluation. The cause of the reported event cannot be determined. The cv-180 instruction manual provides users several warnings to mitigate shock. ¿before connecting the endoscope connector to the lightsource, make sure that it is completely dry. Otherwise, electric shock or equipment damage can result. Strictly observe the following precautions. Failure to do so may place the patient and medical personnel in danger of an electric shock. When the light source is used to examine a patient, do not allow metal parts of the endoscope or its accessories to touch metal parts of other system components. Such contact may cause unintended current flow to the patient. Keep fluids away from all electrical equipment. If fluids are spilled on or into the unit, stop operation of the light¿ source immediately and contact olympus. Do not prepare, inspect or use this light source with wet hands.

 
Event Description

Olympus was informed that during or setup, the facility¿s technician was shocked while connecting the gastrointestinal videoscope to the lightsource and video processor. It was reported that the video system might have been powered on but the light source was not. The user facility believes that the videoscope cable may have been connected to the light source when the incident occurred. A second technician present in the room reported observing a flash at the same time the injured technician yelled out from the shock. The technician was sent to the user facility¿s emergency room and was treated for numbness in the hand. The technician is currently doing well and has since returned to full duties. Additionally, it was reported that the user facility¿s biomed removed the light source and video system from service to perform a grounding and current leakage test. No anomalies were found with light source or video system. The biomed also, visually inspected the equipment and found no visible burn marks on the system. The two devices were powered by a non-olympus power source, which was also tested and inspected with no anomalies found.

 
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Brand NameEVIS EXERA ¿ VIDEO SYSTEM CENTER
Type of DeviceVIDEO SYSTEM CENTER
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key8589654
MDR Text Key144390066
Report Number2951238-2019-00819
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/25/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCV-180
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/07/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/23/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 05/08/2019 Patient Sequence Number: 1
Treatment
CLV-180 SERIAL NUMBER (B)(4); GIF-H180J SCOPE SERIAL NUMBER (B)(4); MAJ-1430 CABLE; STRYKER BOOM
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