Model Number TABLETOP |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/01/2020 |
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.The manufacturer internal reference number is: (b)(4).
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Event Description
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A surgeon reported that iop compensation did not activate during an ocular procedure.Patient harm was not reported.Additional information has been requested.
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Manufacturer Narrative
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Additional information has been provided in b.5.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information was received indicating that the issue occurs randomly.It occurs at the beginning, in the middle or at the end of the procedure.Iop compensation is activated but shuts itself off during the procedure for several seconds.This is noticed by the surgeon when the eye becomes soft.The surgeon discontinues suction and then the iop compensation reactivates on its own.Hypotony lasts a few seconds.There have been no long-term clinical consequences.
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Manufacturer Narrative
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The company service representative examined the system.The company service representative confirmed system message (sm) [infusion flow data invalid: iop control functions will be disabled.Check infusion tubing for air bubbles] in the event log which is consistent with the reported issue.The fluidics module was replaced as a prevention.Unrelated to the reported event, the company service representative adjusted the tray arm due to it being blocked.The system was then tested and met all product specifications.Additional information received from company service representative, the issue was found to be random.However, the system has been found to have no problem after multiple checks.The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The customer did not return the cassette for evaluation.The cassette manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The system was found to meet specifications.Therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Event Description
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Further information was received indicating that priming was completed before the procedure began.There is no indication of the tubing being kinked, modified or taped to something.No blockages or flow issues were observed with tubing.
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Manufacturer Narrative
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Additional information has been provided in b.5, d.4, e.1 and h.4.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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