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 Consequences Or Impact To Patient (2199)
Date of Event	11/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject scope was returned to the service center.The standard service evaluation confirmed the reported leak as the scope was found leaking from a cut/hole on the bending section cover.The light guide lens adhesive was peeling and the up/down control knob movement was loose.In addition, a reportable malfunction was noted as the pink colored coating on the probe unit at the distal end had deep cut and a portion of the adhesive at distal end cover was missing.The scope was repaired to standard specifications and returned to the customer.A review of the repair records indicates the scope was last serviced via repair on (b)(6), 2019 for an image problem (passed leak test).As part of the investigation, olympus followed up with the user facility to obtain additional information.The nurse manager at the facility further reported, the intended diagnostic eus procedure was completed.This same device was used to complete the procedure without delay.No other devices were involved during the procedure.There were no injuries or medical intervention associated with this event.The device was inspected prior to use with no abnormalities noted.There was no other physical damage to this device, no kinks or coils in the insertion tube or light guide cable and the device did not sustain a deep impact.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
During reprocessing, the evis exera ii ultrasound gastro-videoscope was found to have a small leak in the bending section cover at the distal end of the scope.No patient injury or harm was reported.
Additional Manufacturer Narrative
The legal manufacturer performed the device history records for this device 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 investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The legal manufacturer determined that since some external force was applied to the acoustic lens, the acoustic lens might have been damaged, resulting in scratches.As stated on the ifu and as a preventive measure, the user manual states: chapter 3 preparation and inspection; 3.2 inspection of the endoscope - 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: 11049599
• Report Number: 8010047-2020-10766
• Device Sequence Number: 19088735
• Product Code: ODG
• UDI-Device Identifier: 04953170355462
• UDI-Public: 04953170355462
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K093395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2021

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: 11/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 02/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1