BIOSENSE WEBSTER INC TRUDI¿ NAVIGATION SYSTEM; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
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Catalog Number FG200000 |
Device Problem
Image Orientation Incorrect (1305)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2023 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent a primary functional endoscopic sinus surgery (fess) revision surgery with a trudi¿ navigation system and a location inaccuracy occurred.It was reported that the trudi curette was displayed inaccurately by 5mm on the trudi¿ navigation system during the procedure in the operating room.They replaced the trudi curette two times without resolution.The procedure continued without resolution.There was no patient consequence, as such, no medical intervention required.No non-acclarent devices were used, and it was considered the acclarent devices did not function as expected.This event was originally considered non-reportable, however, a product investigation identified a reportable product malfunction on 1-sep-2023.
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Manufacturer Narrative
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Device investigation details: an investigation was initiated by the manufacturer to investigate the issue.A software defect was discovered which affects the location accuracy of the curette tool on the trudi system display.The issue is being addressed as part of an internal corrective action.The history of customer complaints reported during the last year associated with trudi system #100045 was reviewed.No similar complaints were found.The manufacturing record evaluation was performed on trudi system #100045, and no internal actions related to the reported complaint condition were identified.H9.Fda correction/ removal reporting no: 3005172759-09182023-001-c if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref # (b)(4).
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Manufacturer Narrative
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The manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 1-nov-2023, the product investigation was reopen to correct the following information: field h6.Component code was corrected from "appropriate term/code not available (g07002)" to "computer software (g02008)".
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