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

Model Number GF-UCT180

Device Problems Poor Quality Image (1408); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

The subject scope was returned to the service center.The evaluation found that the probe unit cover at the distal end was chipped / dented.The reported flickering image was confirmed as fluid/corrosion was found inside the control body, the scope connector and from the ultrasound connector.The scope was found leaking from the scope connector and inside the instrument channel.The instrument channel was inspected and scrape marks were noted along the channel wall.Additionally, the angulations and control knob movement were below specifications.The scope was repaired and returned to the customer.A review of the scope's repair history indicated the scope was last repaired to specification on (b)(6) 2020 the investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The service center was informed that during preparation for use, the evis exera ii ultrasound gastro-video scope's ultra sound connector was not working properly as the screen would turn grey and would flicker on the screen.No patient injury or harm was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer and to update the following sections: b3, g4, h2, h4, h6 and h10.As part of the investigation, olympus followed up with the user facility to obtain additional information.The nurse at the user facility further reported there was no delay in the procedure in which the subject device was used.The scope was replaced with another scope to complete the procedure no other devices were replaced during the procedure.The connections and settings were checked and found to be secured.There were no errors, alert tones or alarms associated with this event.Also, there were no foreign objects such as detergent remnants, hard water residue, finger grease, dust or lint on the electrical contacts.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 the root cause of the reportable malfunction was due to external force being applied to the probe unit/acoustic lens.As stated on the ifu and as a preventive measure, the user manual states: 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
• 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
• MDR Report Key: 10969845
• MDR Text Key: 227202337
• Report Number: 8010047-2020-10040
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1