MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H290

Device Problems Contamination /Decontamination Problem (2895); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The user facility provided additional information regarding the cleaning, the disinfection and the sterilization processes performed onsite for the endoscopes.There was no delay in the start of precleaning.During precleaning the scope insertion section was wiped, and instrument/suction channel aspirated with water.The scope air/water channel was also flushed with air and water.During manual cleaning there were no abnormalities in the accessories used for cleaning.The scope was immersed in detergent solution, and all external surfaces were wiped/brushed with clean lint free cloths/brushes.All channels were brushed and flushed with the detergent solution.The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, amount of air supplied is insufficient due to clogging of the air/water nozzle, bending angle insufficient due to elongation of the angle wire, play of the angle knob out of the normal state due to elongation of the angle wire, curved pipe fell down due to handling, curved pipe deformed, scratches on the insertion tube, insertion tube discolored, wrinkles in insertion tube, curved rubber scratches, curved rubber adhesive missing, curved rubber adhesive part discolored, amount of water supplied insufficient due to clogging of the air/water nozzle, air and water nozzles are clogged and the draining function reduced, foreign object inside the nozzle, scratches found on the tip cover, discoloration of the objective lens, cloudiness of the image, forceps flare occurred, scratches found on the operation part, discoloration of the operation part, scratches found on the switch box, scratches on the operation unit cover, scratches on the up/down/left/right knob, scratches on the up/down angle fixing lever, scratches found on the grip, scratches found on the universal cord, scratches are found on the operation part side oredome of the universal cord, scratches found on the scope connector, scratches on the scope connector cover, and scratches on the right/left angle fixing knob.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

A user facility submitted a repair request to the olympus service center, for an evis lucera elite gastrointestinal videoscope having poor air supply.The event occurred during an unknown diagnostic procedure and the procedure was completed.Upon inspection and testing of the returned device, foreign material was found clogged in the scope air/water nozzle due to insufficient cleaning.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There was no report of patient harm or user injury associated with this event.

Event Description

The poor air supply event occurred during a diagnostic upper gastrointestinal examination.The device had been inspected prior to use.The procedure was completed with the same set of equipment.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Updated fields: h6 and h10.The b5 and d10 fields were corrected based on information available at the time of the initial submission.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 6 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause for the foreign material found in the nozzle could not be established.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: operation manual gif/cf/pcf-290 series operation chapter 3 preparation and inspection describes the detection method.Instruction manual gif/cf/pcf-290 series cleaning/disinfection/sterilization chapter 5 reprocessing of endoscopes describes preventive measures.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): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17628223
• MDR Text Key: 322035199
• Report Number: 9610595-2023-12267
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/06/2023

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-H290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 08/30/2023
• Supplement Dates FDA Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2017
• 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
• Treatment: CV-290