Catalog Number 8065751908 |
Device Problem
Break (1069)
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Patient Problem
Vitreous Loss (2142)
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Event Date 01/15/2019 |
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 the manufacturer internal reference number is: (b)(4).
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Event Description
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A surgeon reported the trocars were damaged and liquid began to flow out of the eye during a vitrectomy procedure.The procedure was completed with a delay and annoyance to the patient.No known patient harm.No additional information is expected.
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Manufacturer Narrative
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No sample has been returned for evaluation for the report of leaking trocar; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there are three additional complaints associated with the lot for the reported issue.The video attached to the parent complaint was reviewed by the manufacturing site.The video does confirm the a leaking trocar.No sample was returned; however the returned customer video confirmed the trocar leaked.The exact root cause for this complaint is unknown, how and when the trocar began leaking could not be determined.The exact root cause for this complaint is unknown.Investigations have been completed and manufacturing process controls have been implemented to improve the performance of the valves.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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