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

Model Number	GF-UE160-AL5
Medical Device Problem Codes	Image Display Error/Artifact (1304); Scratched Material (3020); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The loaner device was returned to olympus and inspected.During inspection, a deep cut was found on the probe unit pink rubber.Also found was a scratch on the cover of the distal sheath, a stiff angulation control knob, and a dent in the ultrasound cord.The event is under investigation.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Upon manufacturer inspection of a returned loaner ultrasonic gastrovideoscope, a deep cut in the pink rubber was identified.There was no patient involvement in this event.No issues were reported by the customer facility.
Additional Manufacturer Narrative
There is more information on the device evaluation.This supplemental report is being submitted to provide this information.Please see the updates in sections: g3, g6, h2, h4, h6, and h10.The device history record review confirmed that device has no abnormalities, special adoption, or variations in manufacturing.Considering the year of manufacture of the equipment, there is a possibility of pink probe unit being cut is due to deterioration over time.In addition, it is likely that the phenomenon occurred due to the application of external force such as strong rubbing against the relevant part during normal use including reprocessing.The instructions for use includes the following statements: inspection of the endoscope 3.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, forming 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: 11246083
• Report Number: 8010047-2021-01972
• Device Sequence Number: 3433514
• Product Code: ODG
• UDI-Device Identifier: 04953170203107
• UDI-Public: 04953170203107
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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: Other
• Device Model Number: GF-UE160-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/03/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1