MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC GASTROVIDEOSCOPE

Model Number	GF-UE160-AL5
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report has was returned and evaluated by olympus.A review of device history record (dhr) confirmed that there were no leaks and no acoustic lens scratches from the a rubber glue at the time of shipment.Physical evaluation of the device showed the following: acoustic lens scratches, leakage from 'a' rubber adhesive, perforations, cuts, and scratches on probe unit coating exposing the core, abnormal sensitivity of ultrasonic images, deterioration of 'a' blade, discoloration, cloudiness, and corrosion of the insertion part, poor contact at the connector, deformation of video cable, damaged ultrasonic cable connector and angle play.The instructions for use state: " do not apply shock to the distal end of the insertion tube, particularly the ultrasonic transducer and the objective lens surface at the distal end.This could cause abnormalities in the visual and / or ultrasonic images." it was concluded, the probable cause is user handling,external force applied.
Event or Problem Description
It was reported during reprocessing of ultrasonic gastrovideoscope, air/water leakage was noted at the distal tip.No patient contact/impact.
Additional Manufacturer Narrative
Additional information has been received for this event.This supplemental report is being submitted to provide this information.Please see the updates.The event took place during reprocessing.The intended procedure, a diagnostic eus procedure, had been performed with no delays and no harm to the patient.No other devices were involved in this event.The same device had been used for the procedure.Other devices that were used in conjunction with this ultrasound scope were olympus equipment.The scope was reprocessed in the olympus oer washer.

• Brand Name: ULTRASONIC GASTROVIDEOSCOPE
• Common Device Name: ULTRASONIC GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10899645
• Report Number: 8010047-2020-09418
• Device Sequence Number: 19137688
• Product Code: ODG
• UDI-Device Identifier: 04953170203107
• UDI-Public: 04953170203107
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051541
• Number of Events Summarized: 1
• Summary Report (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): 12/21/2020

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: No Information
• Device Model Number: GF-UE160-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1