Catalog Number 8065752134 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2022 |
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 the vitrectome body was detached from the probe handle during a vitrectomy procedure.The same issue happened with another vitrectome used consecutively.The product was replaced with a cutter which was used on several occasions, and it was able to perform cutting without problems.No patient harm was reported.
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Manufacturer Narrative
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A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.A sample was not returned and a review of the lot number provided indicated the product was used beyond its expiration date.No specific action with regard to this complaint was taken by the manufacturing location because the complaint sample exceeded its expiration date and should not have been used.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.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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