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  

Event Description

It was reported by the customer, after a procedure and during reprocessing, the evis exera ii ultrasound gastrovideoscope had leakage.Upon follow-up with the customer, it was clarified the device was reprocessed several times and the following day blood traces were found on the tip, without having technical faults (leaks, etc.).The customer stated the device was being reprocessed correctly.The device was left hanging and the next day there were blood traces on the tip.No patient harm reported.

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.One (1) colony forming unit (cfu) of pantoea agglomerans was identified in the biopsy/suction channel.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 on the outside of the device.It was unknown if there were blood traces in the inside.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.

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.The device met all specifications at the time of shipment.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, the cause of the incorrect reprocessing likely occurred from the user not properly reprocessing the device.The cause of the probe housing impact points and heavy scratches likely occurred due to an external force applied to the part.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: 12778077
• MDR Text Key: 283689382
• Report Number: 8010047-2021-14323
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

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: 11/01/2021
• 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: 08/06/2015
• 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