FUJIFILM CORPORATION FUJIFILM VIDEO ENDOSCOPE EC-760R-V/L; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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Model Number EC-760R-V/L |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Abrasion (1689)
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Event Date 05/22/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The subject scope was inspected at the repair facility and no abnormalities or malfunctions that could cause serious injury were noted.Fujifilm determined this incident was minor injury and recurrence of the issue would not likely lead to a serious injury based on the investigation result by the repair facility.As such, fujifilm initially determined this incident as non-reportable.However, fujifilm became aware that the importer mdrs were submitted dated july 7, 2023.Therefore, ftyo determined to submit a manufacturer mdr to supplement to an importer mdr in an abundance of caution.
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Event Description
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On (b)(6) 2023, fujifilm corporation was informed of an event involving ec-760r-v/l.This report addresses the first of three events that occurred at the user facility using the same scope.It was reported that during a procedure the patient experienced a minor colon abrasion that is suspected to have been caused by a sharp point on the distal end.The scope was switched causing a slight delay.Thereafter, the procedure was completed successfully without further incident.There is no death associated with the event.
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Manufacturer Narrative
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This supplement is being submitted to fda as a result of fujifilm corporation's commitment to perform a retrospective review of all mdrs submitted between october 1, 2021 and october 12, 2023, due to fda 483 observations issued to fujifilm corporation on september 22, 2023.This supplement includes missing or incorrect information in the original mdr filing, and previous supplements where applicable.
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