MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

Device Problems Device Reprocessing Problem (1091); Device Contamination with Body Fluid (2317)

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

Event Type  malfunction  

Manufacturer Narrative

After the device was returned to olympus, it was sent out for additional testing.The hygiene microbiological investigation report indicated the channels/distal end/forceps raiser of the scope were cultured.No bacteria were found.The results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.The device was returned to olympus for evaluation and the issue was not confirmed.No fault was detected during the incoming inspection and no traces of blood were found.The contact person/occupation of the reporter is unknown.A supplemental report will be submitted should additional information be made available.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.Date of event: week of (b)(6) 2021.

Event Description

It was reported by the customer, after use, and after performing the protocol of brushing, cleaning, and disinfection of the evis exera ii ultrasound gastrovideoscope per the instructions for use, organic traces (blood) in the tip of the scope were found.The scope was reprocessed two (2) times on the same day and the issue remained.The device was not used on a patient after the first reprocessing.The preventive service of the hospital was informed, and it was advised the etd3 plus paa automatic endoscope repressor (aer) should be repaired.No patient harm reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the olympus field service technician and the updated device evaluation.Additional information was provided regarding the device evaluation.Glue was missing on the probe.There was corrosion around the nozzle unit.The bending section was worn out.The connecting part of bending section and insertion tube was cut.The suction cylinder had corrosion and the air/water cylinder was damaged.The light guide tube / universal tube / video connector tube was buckled.Humidity had entered the connection of the us connector with the us processor.The ultrasonic image had broken sound wires.

Event Description

Additional information was received from the olympus field service technician.Once the scope was removed from the washer, there was debris.In the pre-cleaning area, the user passed water or air and debris continued to come out.It was unknown specifically what channel.

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 over 4 years since the subject device was manufactured.Based on the results of the investigation, the cause of the foreign material remaining on the device likely occurred due to not being reprocessed properly per the instructions for use.The specific root cause could not be determined at this time.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• 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: 12778006
• MDR Text Key: 282920512
• Report Number: 8010047-2021-14321
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170341809
• UDI-Public: 04953170341809
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2017
• 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