Catalog Number 8065752201 |
Device Problems
Device Alarm System (1012); Suction Problem (2170); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/25/2021 |
Event Type
malfunction
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Event Description
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A physician reported an occlusion tone was heard which was not the usual noise with a poor aspiration when they started digging the furrows (quad) quadrant during the procedure.An error message was also displayed.The cassette was changed and the procedure was completed.There was no patient harm.
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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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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.Based on our findings, no trending was identified.The sample was received; however, the sample was inadvertently misplaced.A careful and comprehensive search for the sample was completed; regrettably, the sample was not found after an exhaustive search.If a sample is found at a later date, the investigation will be reopened and the sample evaluated.The root cause of the customer's complaint could not be established as the sample was unable to be evaluated.After the investigation of this complaint, it has been determined that no action will be taken at this time.Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The returned sample was visually inspected and functionally tested.No defects were observed.Both irrigation and aspiration luers were intact.Flare shape was observed in the blue socket fitting at the aspiration tubing insertion end.The sample primed and tuned with a handpiece successfully.The sample could be recognized and the service data could be retrieved from the console.Maximum vacuum was achieved during priming sequence and aspiration flow rates were measured and found to be within specifications.Fluid flowed from the bss (balanced salt solution) bottle through the irrigation path continuously, no fluidic anomalies were observed.No occlusion or obstruction was identified during inspection and functional testing.The root cause of the customer's complaint could not be established since the returned sample met specifications.No contributing factors could be identified that could cause the reported complaint.After an investigation of this complaint, it has been determined that this sample functioned per specifications; therefore, no corrective action is required at this time.Current tracking indicates no adverse trend for this lot for this event as the product met specifications.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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