Model Number 66800041 |
Device Problems
Fluid/Blood Leak (1250); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/24/2021 |
Event Type
malfunction
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Event Description
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It was reported that during the debridement utilizing a versajet ii exact disposable handpiece 45 degree x 14mm, the hand-piece saline leakage occurred from the orange cartridge when priming saline.In addition, the cartridge has come off the console.There was no significant delay and the procedure was finished using a smith & nephew back up.Patient was not harmed.
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Manufacturer Narrative
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H3, h6: the device that was used in treatment was not returned for evaluation with all information provided we could not establish a relationship between the device and the reported event.Probable root cause may include a component failure or connection issue.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.A complaint history review found other failures related to the report event.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.
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Event Description
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It was reported that during the debridement utilizing a versajet ii exact disposable handpiece 45 degree x 14mm, the hand-piece saline leakage occurred from the orange cartridge when priming saline.In addition, the cartridge has come off the console.The procedure was finished using a smith & nephew back up.No delay reported.Patient was not harmed.
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Manufacturer Narrative
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H10.The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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Search Alerts/Recalls
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