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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II VIDEO SYSTEM CENTER Back to Search Results
Model Number CV-180
Device Problem Loose or Intermittent Connection (1371)
Patient Problems Burn(s) (1757); Electric Shock (2554)
Event Type  Injury  
Event Description

The service center was informed that during a diagnostic colorectal procedure, the patient jumped and complained of a burning feeling and electricity. As a result, the patient sustained a burn. The patient¿s course of treatment is unknown. It is unknown if the intended procedure was completed. This is 4 of 4 reports. A video processor cv-180, serial# (b)(4), ver. 4. 00, was returned for evaluation. A visual inspection was performed upon received device and found no abnormalities on the appearance. The device was equipped with 2 correct fuses rating t5al250v and passed the electrical safety test. The processor was initially checked together with the customer's lightsource clv-180 (sn (b)(4)), and using our test endoscopes pcf-q180l. No image was observed on the monitor screen as it only displayed the color bar output signals. Troubleshooting was performed, and found a loose connection (where the front socket connecting to the patient board). The patient board is also faulty giving no image at all. Further troubleshooting was performed with a good test patient board installed and the image resumed to normal for all signals. The processor was then checked with the customer's lightsource again, and passed the functional inspection. Based on the evaluation findings, the processor has no image due to faulty patient board; however, this issue would not contribute to the reported complaint. The cause of the reported complaint could not be conclusively determined as the customer's endoscope was not returned for evaluation. The instruction manual states ¿ do not continue observation in the proximity to tissue or keep the distal end of the endoscope in contact with living tissue for a long time. It may cause patient burns. If the endoscopic image dims during use, blood, mucus or debris may adhere to the light guide on the distal end of the endoscope. Carefully withdraw the endoscope from the patient and remove the blood or mucus in order to obtain optimum illumination and to ensure the safety of the examination. If you continue to use the endoscope in such a condition, the distal end temperature may rise and cause mucosal burns. It may also cause patient and/or operator injury. When non-medical electrical ancillary equipment is used, connect its power cord via an isolation transformer prior to connecting it to this video system center. Failure to do so can cause electric shock, burns and/or fire. ¿.

 
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Brand NameEVIS EXERA II 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
MDR Report Key9897493
MDR Text Key194350659
Report Number2951238-2020-00398
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 03/04/2020,03/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/30/2020
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 Manufacturer03/06/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date03/04/2020
Event Location Hospital
Date Report TO Manufacturer03/04/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/30/2020 Patient Sequence Number: 1
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