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

Model Number CV-180

Device Problems No Display/Image (1183); 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,(b)(4), 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.¿ this importer report is to account for patient 1.

• Brand Name: EVIS EXERA II VIDEO SYSTEM CENTER
• Type of Device: VIDEO SYSTEM CENTER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9897263
• MDR Text Key: 197019168
• Report Number: 2951238-2020-00396
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other