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

Model Number	GF-UE160-AL5
Medical Device Problem Codes	Dent in Material (2526); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report has been evaluated by olympus.Preliminary findings are reported.The investigation is ongoing.The definitive cause of the customer's experience cannot be determined at this time.Physical evaluation of the complaint device reveals: the probe unit has sharp dents.The m-zif connector lock is bent preventing image check.The control body is dry.The control knob has low tensions.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
It is reported prior to an unspecified diagnostic procedure using an ultrasonic gastrovideoscope, the scope was inspected and found to have the silver ring that connects to the ultrasound machine was bent and not properly locking to give an image.This occurrence did not cause a delay in the procedure.The procedure was successfully completed with a second device.No patient demographics are available.There was no impact to the patient as a result of this occurrence.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely an external force was applied to the acoustic lens resulting in scratches (shavings).The following statements are in the instructions for use which may detect the event: "inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, scratching, sagging, deformation, excessive bending, protruding objects or other irregularities.".

• 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: 11254681
• Report Number: 8010047-2021-02022
• Device Sequence Number: 3477459
• Product Code: ODG
• UDI-Device Identifier: 04953170310546
• UDI-Public: 04953170310546
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K051541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2021

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-UE160-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1