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

Model Number GIF-HQ290

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2021

Event Type  malfunction  

Event Description

The device was returned for repair by the customer for the issue of buttons not working and causing an image freeze during preparation for use.There is no patient involvement.Upon evaluation of the returned device, when the device was stripped to component level, it was observed that besides the four angulation blocks present on the left, right, up, and down angles, there was present an additional angulation block in the switch head mount of the control body.This medwatch is being submitted for the reportable issue of the additional angulation block found in the switch head mount of the control body during device evaluation.

Manufacturer Narrative

Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.This device is not sold in the us, but a similar device is.Upon evaluation of the returned device, when the device was stripped to component level, it was observed that besides the four angulation blocks present on the left, right, up, and down angles, there was present an additional angulation block in the switch head mount of the control body.Other observations are number 1 button leaking and inoperative and delamination on insertion tube.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Manufacturer Narrative

Correction: h10 - initial medwatch h10 field contained the statement "evaluation is ongoing." this statement was erroneous, and should have instead stated "investigation is ongoing." the evaluation was complete at the time of the initial medwatch.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a definitive root cause could not be established.It was presumed that an extra angulation block was left inside the switch box during the previous repair.Users can detect the suggested event properly by handling the device in accordance with the following instructions for use (ifu): "warning: check that all remote switches work normally even if they are not expected to be operated.Otherwise, the endoscopic image may freeze, or other irregularities may occur during examination and may cause patient injury, bleeding, and/or perforation." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13540636
• MDR Text Key: 285691760
• Report Number: 8010047-2022-03023
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-HQ290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 02/16/2022
• Supplement Dates Manufacturer Received: 03/01/2022
• Supplement Dates FDA Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1