Catalog Number 8065752022 |
Device Problem
Sticking (1597)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/09/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).
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Event Description
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An ophthalmic surgeon reported that the cutter would not pull out from the trocar during a procedure.The procedure was completed without replacing the product.No patient harm reported.A product sample has been requested, however, it has not been received for evaluation at the manufacturing site.
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Manufacturer Narrative
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No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.The trocar cannula and probe samples were visually inspected.The cannula was then dimensionally inspected for inner diameter and was found conforming.The probe needle body, middle, and tip were measured and deemed conforming.The probe needle was fit tested for function into a conforming trocar and the fit was deemed conforming.The probe and cannula testing met specification.The exact root cause of the probe could pull probe from trocar cannot be determined from this evaluation.No specific action with regard to this complaint was taken by the manufacturing location because the probe was manufactured to its specification.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.(b)(4).
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Search Alerts/Recalls
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