Catalog Number 8065751912 |
Device Problems
Leak/Splash (1354); Device Slipped (1584)
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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.(b)(4).
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Event Description
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A customer reported leaky trocar valves during surgery and loss of tightness.The reporter informed that "there is no evidence that the issue has affected any patient." there are no product samples available for evaluation.This is the fourth of five product associated with this report.
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Manufacturer Narrative
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No sample has been returned for evaluation; 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.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.(b)(4).
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Search Alerts/Recalls
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