Catalog Number 8065751900 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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 certified ophthalmic assistant reported the trocar valves from the vitrectomy packs were not working during an unknown number of procedures.There was no known harm to the patient or patients.Additional information was requested; however, none has been received to date.
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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 no additional complaints associated with the lot for the reported issue.No sample was returned and the device history record review of the lot number provided indicated product was processed and released according to the product¿s acceptance criteria, therefore the root cause for the defect experienced by the customer cannot be determined.The exact root cause for this complaint is unknown.Investigations have been completed and actions are presently being implemented in order 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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Search Alerts/Recalls
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