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

Model Number	GF-UC140P-AL5
Medical Device Problem Codes	Fluid/Blood Leak (1250); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no additional information for this event as yet.Event date is not known.Supplemental report(s) will be filed as any information becomes available.The device has been returned and a device evaluation completed for it.Manufacture date of the device is not known.Upon inspection and testing, it was observed that there was peeling on the light guide lens cement.The device had a leak from the rubber insulation and the probe unit o-ring.User complaint of leak was confirmed.Additionally, the f-knobs had play.Wear and tear was observed on the device.
Event or Problem Description
As reported for this event, leaking was observed at the end of the rubber tip.There is no reported harm or adverse impact to any patient.
Additional Manufacturer Narrative
There is more information on the device evaluation.This supplemental report is being submitted to provide this information.The device history record review confirmed that device has no abnormalities, special adoption, or variations in manufacturing.The root cause of the issue of peeling of the crack of the rubber insulation cover and peeling of the light guide lens cement which led to the staining of the lens cannot be conclusively determined.The possible causes can be as follows: issues occurred due to excessive impact on the distal end.Issues occurred due to deterioration of the part concerned due to factors such as the use method and environment.

• 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: 10646365
• Report Number: 8010047-2020-07349
• Device Sequence Number: 17214427
• Product Code: ODG
• UDI-Device Identifier: 04953170341748
• UDI-Public: 04953170341748
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/02/2020

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-UC140P-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1