MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-EZ1500

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus service for evaluation.Olympus service visually inspected the device and found no defects.Olympus services conducted device surface temperature monitoring to reproduce the reported event.A significant increase in temperature was observed while activating the optical output of the video system center.The most significant increase in temperature was observed whilst activating the white light mode at maximum output.The highest temperature recorded at the distal end was 72.5 degrees celsius and the ambient temperature was 23 degrees celsius.Olympus service performed a surface contact test by pressing the distal end against the surface of nitrile inspection gloves.Olympus service confirmed that direct contact with gloves burns them in white light imaging mode.Narrow band imaging (nbi) mode and red dichromatic imaging (rdi) mode did not burn the gloves, but made marks on the gloves.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 by the user that the distal end of two olympus 1500 series endoscopes became hot.One of the hospital¿s endoscopists experienced this issue during preparation on november 23 and at the beginning of procedures on november 24.The endoscopist touched the distal tip of the device with gloves on in order to protect the patient from the device¿s light and noticed that the tip got hot.A nurse then touched the tip of device with gloves on for about 5 seconds, the device made a mark on the gloves with its heat.There were no burns on the skin of the nurse's hands.The endoscopist continued using the device to complete the procedure.The device was being used in normal light mode at the timing the event occurred.The device -s/n (b)(4) has been used a total of 8 times but has not been used thereafter because the washing cycle failed.The device had been reprocessed with a non-olympus automated endoscope reprocessor, getting washer.There was no report of patient injury associated with the event.No abnormalities occurred on the other endoscopes including the olympus 290 series that the user facility owns.This is second of two reports.

Manufacturer Narrative

This supplemental report is being submitted to report the withdrawal of mfr report #8010047-2020-10949 and correct the initial report.Olympus re-evaluated the event reported in the initial report and determined that the failure mode is not a mdr reportable malfunction.If additional information becomes available, this report will be supplemented.

• Brand Name: GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11070568
• MDR Text Key: 223622671
• Report Number: 8010047-2020-10949
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-EZ1500
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1