Catalog Number 8065752435 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2022 |
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 physician reported while inserting the trocar canula into the patient's eye and attempting to insert a cutter or other device, the valve portion of the trocar had lifted and was unable to be used during cataract/vitrectomy combination surgery.The surgery was completed after replacing the trocar with another one.There was no patient harm.
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Manufacturer Narrative
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Three opened trocar handle blade assemblies and two opened trocar cannula hub assemblies in a bag within a tray were received.The returned cannula/hub samples were visually inspected and were found to be conforming.The returned cannula/hub samples were then dimensionally inspected for cannula inner diameter and were found conforming.A functional fit test could not be performed with the returned probe was not returned.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The returned cannula/hub samples were found to be conforming, therefore a product fit issue as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the trocar was manufactured to specifications.All trocar assemblies are 100% inspected for gage size.Any non-conformances found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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