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

Model Number	GF-UE160-AL5
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.During the evaluation, tears were found on the pink rubber of the scope and an exposed core.The ultrasound image contained a shadow on the echo line.The insertion tube was found with a minor dent and the ultrasound cord contained scratches on the boot.No other issues were found during the device inspection.If additional information is obtained a supplemental report will be filed.
Event or Problem Description
A user facility reported a leak on a gastrovideoscope.One of the caps came off when washing the scope.No patient involvement or injuries were reported.No additional information has been obtained.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation and information received regarding the reporting person's position.Based on the results of the legal manufacturer's investigation, the scratches (tears and exposed core) observed on the pink rubber of the ultrasonic probe were likely caused by physical stress / external forces being applied.Since the subject device was manufactured more than 7 years ago, it is possible the device was impacted by aging deterioration.A review of the instructions for use identified the following verbiage for 'inspection of the endoscope': "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." per the legal manufacturer, the other issues identified in the initial report (ultrasound image with shadow, insertion tube found with minor dent and ultrasound cord with scratch on the boot) have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.

• 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: 10971667
• Report Number: 8010047-2020-10058
• Device Sequence Number: 16954261
• Product Code: ODG
• UDI-Device Identifier: 04953170310546
• UDI-Public: 04953170310546
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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: 11/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1