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

Model Number	GF-UCT180
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject scope was returned to the service center.The evaluation confirmed the reported malfunction as the elevator channel plug was loose and leaking.There were two more leaks found; probe unit was loose / leaking and at the instrument channel.Bx channel.The instrument channel was found to have internal tear damage.Additionally, the forceps cover glue was peeling, the bending section cover adhesive was cracked.Switch# 1 was cut, the scope connector was loose, the ultrasound image has 4 broken elements and the control knobs have play/loose.A review of the previous repair indicates, the scope's instrument channel was replaced on (b)(6) 2020.The scope was repaired and returned to the customer.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The service center was informed by the customer that during preparation for use, the evis exera ii ultrasound gastro-videoscope's water jet channel was loose.No patient injury or harm was reported.
Additional Manufacturer Narrative
This supplemental report was submitted to provide additional information from the legal manufacturer and to update the following sections: d8, g3, g6, h2, h4, h6 and h10.The legal manufacturer performed the device history records for this device; no abnormalities were found.The investigation was completed and the legal manufacturer determined that there is no manufacturing, material or processing related cause for this failure mode.The likely root cause was due to external force applied to the distal end, leading to the peeling of the glue at the tip.As stated on the ifu and as a preventive measure, the user manual states: chapter 3 preparation and inspection- inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, scratches, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.Olympus will continue to monitor complaints for this device.

• 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: 11153923
• Report Number: 8010047-2021-01231
• Device Sequence Number: 11404073
• Product Code: ODG
• UDI-Device Identifier: 04953170355462
• UDI-Public: 04953170355462
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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: Other
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1