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

Model Number CV-180

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

A video processor cv-180, serial# (b)(4), ver.4.00, was returned for evaluation.A visual inspection was performed on the 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 report is to account for patient 2.This event has been reported by the importer on mdr# (b)(4).

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 3 of 4 reports.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Please see the updates in sections: g4, g7, h2 and h10.The legal manufacturer reviewed the contents of this complaint.Dhrs were checked, and it was confirmed that there were no manufacturing abnormalities, special adoptions, or variations.The legal manufacturer reported that the cause for the reported event can be attributed to the following: since no abnormalities related to the phenomena related cv-180 were identified in the on-site surveys, it was speculated that they were not caused by cv-180.[burns] at the time the phenomenon was noted, it is presumed that the use of the device in the following settings and handling caused the tip of the endoscope to become hot and resulted in burns to the patient.During manual dimming, the amount of light was not used at the minimum brightness required for observation.It had been observed close to the mucosa for a long time.[electric shock] it is speculated that the following causes attributed to the electrical shock.Fluid remained in the endoscope used, and it was used in a condition of insufficient drying.

• 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: 9897581
• MDR Text Key: 190354027
• Report Number: 8010047-2020-01891
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

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?: No
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other