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

Model Number GIF-H290

Device Problem Image Display Error/Artifact (1304)

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

Event Type  malfunction  

Event Description

It was reported by the customer, during preparation for use for a diagnostic procedure, the evis lucera elite gastrointestinal videoscope presented an e315 scope error message.The intended procedure was completed with the same device and no surgical delay.No patient harm reported.

Manufacturer Narrative

The device was returned to olympus for evaluation and the reported issue was confirmed.Foreign material was coming out from s-cylinder due to insufficient cleaning (handling issue).There was a gap at the adhesive part of bending section cover.There was a crease at the connecting tube.Switch one (1) had a pin hole.The sc-cover unit had corrosion due to leakage.The image guide protector had a scratch.The angulation in the up direction and the gap at the up/down knob were out of standards due to a worn angle wire.There were liquid leaks due to deformation of the up/down/right/left knob.The condition of the light guide bundle was not good.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The initial reported a e315 error.This supplemental report is correcting the reportable malfunction of foreign material exiting the cylinder which is caused by insufficient cleaning.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and b5 correction.B5 - corrected the reportable event.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, the cause of the foreign material exiting the cylinder was likely from one of the following events: reprocessing method at the facility differed from the instructions for use recommendation.The facility staff was less trained in reprocessing and/or device handling in accordance with the instructions for use statement.The specific root cause could not be determined at this time.The following information is stated in the instructions for use regarding reprocessing: "an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.Precleaning the endoscope and accessories describes about pre-cleaning immediately after procedure to prevent adhesion of dirt.If the endoscope and accessories used in the patient procedure are not immediately cleaned after each patient procedure, residual organic debris will begin to dry and solidify, hindering effective removal and reprocessing efficacy.Preclean the endoscope and the accessories at the bedside in the patient procedure room immediately after each patient procedure.Manually cleaning the endoscope and accessories describes about detailed brushing/cleaning method of each channel." 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: 13391907
• MDR Text Key: 284703417
• Report Number: 8010047-2022-02178
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2016
• 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