D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. 27G CANNULA SET WITH HIGH FLOW INFUSION LINE; DORC TROCAR SYSTEM,
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Catalog Number 1272.ED27 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/15/2022 |
Event Type
malfunction
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Event Description
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We have been informed that during posterior surgery, when removing the cannula, the metal part broke and fell outside the operative area.There is no report of patient/user harm.No report of prolonged or delayed surgery.
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Manufacturer Narrative
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The complaint is under investigation.
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Event Description
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We have been informed that during posterior surgery, when removing the cannula, the metal part broke and fell outside the operative area.There is no report of patient/user harm.No report of prolonged or delayed surgery.
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Manufacturer Narrative
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In regard to this complaint, one broken cannula was received.The capillary that is situated beneath the yellow ring had broken off.The funnel above the ring appeared to be missing.Close examination showed deformation of the capillary at the breaking point, suggesting that the capillary itself was grabbed with pliers or forceps, rather than the yellow ring.Though the observed deformation may have caused the break, it might just have occurred when the broken capillary was removed from the eye after breaking.Device history record review revealed no deviations and a database search showed that no similar complaints have been reported on any lot previously.Based on the investigation performed, the cause of failure could not be determined.The risk identified is included in the risk management documentation.Trend analysis indicates that the product is performing within anticipated rates.Complaints will be closely monitored to identify any significant adverse trends.
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Search Alerts/Recalls
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