Catalog Number 8065750517 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/21/2019 |
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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A pharmacist reported that the end of a phaco tip broke during a cataract procedure.The surgeon retrieved the end without damage to the patient.
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Manufacturer Narrative
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The lot complaint history was reviewed, this is the second complaint for the finish goods lot; however, the first for this issue for this lot.The device history record shows the product was released per specifications.The used returned sample was visually inspected and the infusion sleeve entire section at the tip containing the irrigation ports were torn off.Microscopic examination confirmed the entire tip of the infusion sleeve had been torn.The damage observed was consistent with an induced tear that can occur by phaco tip piercing damage.The root cause of the customer's complaint is related to user error as an entire section at the tip of the sleeve was torn off.After an investigation of this complaint, it has been determined that no action since the root cause is related to user error.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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Product manufacturing site updated due to receipt of corrected information.Manufacturer report number corrected and reported under 1644019-2019-00146.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information was received.The pharmacist corrected that the end of the sleeve was broken and not the kelman tip.
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Search Alerts/Recalls
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