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

Model Number	GF-UE160-AL5
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information for this event is not yet available.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 is not known.The user¿s complaint was confirmed.Upon inspection and testing, it was observed that the pink rubber ultrasound probe had a deep cut (hole).Incidental observations were that there was one broken element and scratches on the rubber coating of the distal end.
Event or Problem Description
As reported for this event, the device pink rubber of the ultrasound probe had a hole.There is no reported harm to any patient.
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 investigation, the damage to the probe occurred when an external force was applied by hitting the spot during transportation, storage, use, cleaning, etc.This event can be prevented by observing the items listed in the instruction manual: "do not hit or drop the distal end of the insertion tube when carrying the endoscope by hand.The ultrasonic transducer internal damage can result and/or the ultrasonic image will be abnormal." therefore, it is assumed that this event was caused by the user's handling.

• 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: 11508126
• Report Number: 8010047-2021-03864
• Device Sequence Number: 2777103
• Product Code: ODG
• UDI-Device Identifier: 04953170203107
• UDI-Public: 04953170203107
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2021

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: 02/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1