MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problems Temperature Problem (3022); Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 04/15/2020

Event Type  Injury  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.Olympus (b)(4) field service engineer confirmed the subject device at the facility, but could not duplicate the reported phenomenon.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during an unspecified procedure the distal end of the unspecified endoscope connected to the subject device became hot, the mucous membrane of the patient's rectum was burned, and the physician finger was burned.The patient was fine without extension of hospitalization.Omsc will submit 2 medical device reports (mdr) depending according to the number of adverse events.This report is 2 of 2 reports regarding the physician¿s burn.

Manufacturer Narrative

This supplemental report is being submitted to additional information.The subject device was not returned to olympus medical systems corp.(omsc).Omsc obtained the additional information from the user facility as follows.When the phenomenon occurred, the physician seems have touched the distal end of the subject device with fingers.The subject device was set to automatic brightness adjustment mode and the brightness setting of the subject device was ¿0¿.The non-olympus examination lamp had been installed in the subject device.There was no adhesion of blood and/or tissue on the distal end of the endoscope used with the subject device.There were no scratch and corrosion on the light guide and distal end of the endoscope while the procedure.The endoscope had been reprocessed correctly.The reported phenomenon occurred during the colonoscopy.The procedure completed with another endoscope.Omsc reviewed the manufacture history (dhr) of the device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However, based upon the information from the user facility, there was the possibility that this phenomenon was attributed to the temperature increase of the distal end of the endoscope due to the using the non-olympus examination lamp.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10055388
• MDR Text Key: 200573001
• Report Number: 8010047-2020-02696
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

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: CLV-190
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/16/2020
• Initial Date FDA Received: 05/14/2020
• Supplement Dates Manufacturer Received: 06/03/2020
• Supplement Dates FDA Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other