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

Model Number	GF-UCT180
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to an olympus service center for evaluation and the reported issue was confirmed.The elevator channel was found leaking from the control unit side.The elevator channel was detached with fluid invasion and heavy corrosion.Additional findings were; the probe unit was loose, the forceps cover glue was peeling, there was a broken element on the ultrasound image, there was a crack in the rubber glue on the cover, and the switch was not working.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The user facility reported the evis exera ii ultrasound gastrovideoscope was leaking from the channel irrigation screw on the handle, as well as the biopsy channel.The scope was washed in the machine with the leak test running.The issue was found at reprocessing.No patient involvement was reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the legal manufacturer¿s investigation.The legal manufacturer performed an investigation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the issue could not be conclusively specified.It is likely the event occurred when external force was exerted by strong rubbing or bumping on the area during transportation, storage, use, cleaning, etc.The event could have been prevented by observing the items listed in the instruction manual.Therefore, the probable cause of the event was caused by the user's handling.The instruction for use (ifu) states the following guidelines: warning "do not strike, hit, or drop the endoscope's distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope's distal end, insertion tube, bending it could also cause parts of the endoscope to fall off inside the patient.It could also cause parts of the endoscope to fall off inside the patient.".

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Common Device Name: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11529775
• Report Number: 8010047-2021-03966
• Device Sequence Number: 5211776
• Product Code: ODG
• UDI-Device Identifier: 04953170355462
• UDI-Public: 04953170355462
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K093395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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
• Operator of Device: Health Professional
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1