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Catalog Number ASKU |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/25/2022 |
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 customer reported that an ophthalmic console had problems with the ultrasound and obstruction, even after changing the tips, it stopped working during surgery.It was also reported that during the prime, it does not recognize the cassette, only after multiple attempts the prime was passed.Patient harm was not reported.
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Manufacturer Narrative
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A sample was not received at the manufacturing site for evaluation for the report of the equipment had problems with the ultrasound and obstruction, even after changing the tips it stopped working in the middle of the surgery, therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.A sample was not received at the manufacturing site and no lot information is available, therefore, the root cause for the customer complaint issue cannot be determined.The cause of the reported event cannot be determined with the information obtained, therefore, specific action with regards to this complaint cannot be taken.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.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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