Model Number BL5423WV |
Device Problem
Failure to Cut (2587)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/16/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturing and sterilization records were reviewed and found to be acceptable.Investigation is ongoing.
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Event Description
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It was reported that by the user facility in china that the device failed to perform during a procedure.The vitrectomy cutter in the disposable pack failed to cut the vitreous body normally.Therefore, vitrectomy could not be completed, and it needed to be replaced in order to ensure the safety of the operation.The procedure was extended about 30 minutes and no additional anesthesia was required.No injury or medical intervention was reported.
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Manufacturer Narrative
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Correction to d4 udi: (b)(4).H4 manufacturer date: from 09-jul-2022 to: 17-aug-2022c the lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.This investigation is ongoing.
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Event Description
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The malfunction occurred during the process of cutting the vitreous body.The aspiration continued as normal when the cutting stopped working well.
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Manufacturer Narrative
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The product was received for evaluation.Visual inspection found the 23ga vitrectomy cutter correctly positioned in the tip protector.The tubing is still coiled and taped together but the aspiration tubing has been disconnected from the collection cassette.The vitrectomy cutter and its tubing are clean and dry and do not appear to have been used.The needle is not bent.The port window is in the opened position.The back cap is aligned correctly with the vent hole in the side of the cutter body.The connectors were inspected and no damage was found.A functional test was performed using a stellaris pc system.The cutter had good clean cuts throughout the various cut rates and had good aspiration, as it should.Product evaluation showed the returned product performed as intended the complaint could not be duplicated.We will continue to monitor for the reported complaint.No corrective action is required.
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Search Alerts/Recalls
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