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

Model Number	GF-UC140P-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, a leak was found at the tip of the biopsy channel.The body¿s probe unit contained sharp dents.There were visible scrape marks when inserting the boroscope through the channel.The image contained two broken elements and the objective lens had peeling cement.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 coming from the tip of the scope on a gastrovideoscope.The issue occurred during reprocessing of the device.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 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 legal manufacturer's investigation, the scratches (sharp dents) observed on 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 'preparation and inspection': "inspect the surface of the insertion tube for dents, bulges, swelling or other irregularities.".Per the legal manufacturer, the other issues identified in the initial report (scrape marks in the channel, broken elements, and peeling cement) 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: 11031373
• Report Number: 8010047-2020-10597
• Device Sequence Number: 10929706
• Product Code: ODG
• UDI-Device Identifier: 04953170167638
• UDI-Public: 04953170167638
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K011314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2021

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-UC140P-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1