Catalog Number 8065000096 |
Device Problems
Failure to Cut (2587); Detachment of Device or Device Component (2907); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/18/2022 |
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 physician reported cutter was working halfway through the process, but there was a strange noise and one tube came off during cataract-vitrectomy combination procedure.The procedure was completed after the product was replaced.There was no patient harm.
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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 current tracking, there are no adverse trends for this reported complaint.One wet 27+ gauge (ga) probe manifold was returned and visually inspected.The gray line detached from the 27+ga probe engine due to lack of solvent.The root cause is consistent with a manufacturing error where the driveline likely became occluded during the wetting of the pneumatic tubing with solvent and subsequent insertion to the probe engine.This complaint has been reviewed and it is determined that no further actions will be pursued at this time.After investigation of this complaint and analysis of complaints of this nature confirm no unfavorable trend for this event.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis by the product team.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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