Catalog Number 8065751765 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
Intraocular Pressure Increased (1937)
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Event Date 06/21/2016 |
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 nurse reported that the ophthalmic surgeon experienced a trocar not sealing and he had trouble with maintaining the patient's intraocular pressure during a vitrectomy procedure.There was no harm to the patient.Additional information was requested; however, none has been received to date.
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Manufacturer Narrative
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One opened trocar and infusion cannula were received in a tray for the report of leaking.The returned sample was visually inspected per facility procedure and it was found to be conforming.A review of the related device history record for the reported lot number indicated that the product was processed and released according to the product¿s acceptance criteria.Due to an observed increased trend for this event, an internal investigation was initiated to determine if corrective and preventative actions were necessary.A root cause for the increased complaint rate was found to be related to a manufacturing post assembly inspection practice.No sample was returned for evaluation so it cannot be determined if the complaint can be attributed to the post assembly inspection.The post assembly inspection has been discontinued and an effectiveness check has been established and will be monitored periodically.A non-safety medical device correction was completed on august 12, 2015 and a manufacturing change implemented to address the root cause.All potentially impacted customers have been contacted, trocar plugs made available and other risk mitigations discussed.(only use if lot identified as part of recall).(b)(4).
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Search Alerts/Recalls
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