Catalog Number 316-3174-K01 |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 surgeon reported hearing an occlusion bell when they started fragmentation during a procedure.The handpiece test was performed and an error message appeared stating that it was clogged.When performing priming, an error indicated that it was clogged as well.The procedure was completed after replacing the cassette with another one.There was no harm to the patient.
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Manufacturer Narrative
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A product sample has been received by the manufacturer and it is awaiting evaluation.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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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.The wet cassette was visually inspected and no obvious defects were detected.The sample was tested using the console.The cassette primed and tuned with the ultrasonic handpiece, the 0.9 millimeter tip and infusion sleeve from the lab stock successfully.The root cause of the customer's complaint could not be established; the returned sample met specifications.No contributing factors could be identified that could cause the customer¿s experience.After the investigation of this complaint, it has been determined that this sample met specifications.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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