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

Model Number GIF-H190N

Device Problems Leak/Splash (1354); Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The evaluation found a foreign material inside the biopsy channel and the cleaning brush blocking the channel tube.The evaluation also found a damaged charged coupled device (ccd) unit.The circuit board unit and other parts of the device were corroded due to water leakage all over the device.The faulty parts need replacement to meet olympus functional standard.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

A user facility reported to olympus that during reprocessing, the evis exera iii gastrointestinal videoscope had a broken brush inside the device.Upon inspection and testing of the returned device, it was observed that foreign material was exiting from the biopsy channel.This report is being submitted for the event found during evaluation.There was no harm or user injury reported due to the event.

Manufacturer Narrative

The supplemental report is submitted to correct the aware date on the initial report.The aware date should be december 26 2021.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Manufacturer Narrative

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.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, it is likely the material in the biopsy channel was the tip of the cleaning brush which was used at the user facility.From this finding and the investigation results, the likely cause is below: the brush got broken for its unfitting diameter to the channel diameter, brush deterioration or the like.Then fragments left inside the biopsy channel.Reprocessing method at the facility differed from instructions for use (ifu) recommendation.The facility staff was less trained in reprocessing and/or device handling in accordance with ifu statement.A definitive root cause cannot be identified.Ifu specifies as below: ¿3.8 inspection of the endoscopic system 3 insert the endo therapy accessory through the biopsy valve.Confirm that the endo therapy accessory extends smoothly from the distal end of the endoscope.Also, make sure that no foreign objects come out of the distal end of the endoscope.¿ olympus will continue to monitor the field performance of this device.

• Brand Name: EVIS EXERA LLL 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: 13311038
• MDR Text Key: 295343883
• Report Number: 8010047-2022-01744
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H190N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2021
• 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