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

Model Number	GF-UE160-AL5
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is not yet available for this event.Event date is not known.The device has been returned and a device evaluation completed for it.Manufacture date is not known.Upon inspection and testing, it was observed that the probe unit had sharp dents.Wear and tear was observed on the device.In addition, there was chip on the objective lens and four broken elements of the ultrasound image.Evaluation is still ongoing and supplemental report(s) will be submitted when any information is available.
Event or Problem Description
The device was sent in for repair for an issue with balloons popping during a spy procedure at the liver of a patient, at which time the estimation team observed the probe unit of the device to have sharp dents.There is no reported harm or adverse impact to the patient.
Additional Manufacturer Narrative
Due diligence performed.Additional information is not available for this event, except for initial reporter information.This supplemental report is being submitted to provide.
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 abnormality in manufacturing, concession, and variation.The device has no similar repair history.For the issue of the dent in the probe unit, it is likely the probe unit was damaged because external force was applied to the distal end due to handling.The instructions for use includes the following statements that may have prevented the issue: do not apply shock to the distal end of the insertion section, particularly the ultrasound transducer and the objective lens surface at the distal end.Visual abnormalities may result.

• 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: 11747273
• Report Number: 8010047-2021-05621
• Device Sequence Number: 19850058
• Product Code: ODG
• UDI-Device Identifier: 04953170203107
• UDI-Public: 04953170203107
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2021

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: 03/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 08/09/2021; 08/20/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 08/18/2021; 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1