Catalog Number 8065751155 |
Device Problems
Complete Blockage (1094); Suction Failure (4039)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/08/2023 |
Event Type
malfunction
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Event Description
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A physician reported that the aspiration failure occurred and occlusion sound did not disappear during ultrasound mode with no patient harm.The procedure was completed after replacing the cassette.The procedure type was unknown.
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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.The two returned cassettes were visually inspected and no obvious defects were found.A console representing the current software version was used to test the sample.The cassettes were recognized and could prime and pass intraocular pressure (iop) calibration successfully.No anomalies were observed during priming.No system message code was generated during testing.No leakage was detected from the pump elastomer or on the pump area of the fluidics module.Cleaning process was able to be performed after functional test had completed.No anomalies were observed that would cause or contribute to the reported event.The root cause of the customer's complaint could not be established; the returned samples functioned per specifications.No contributing factors could be identified that could cause the customer¿s experience.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.No adverse trends have been observed associated with the reported product and event.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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