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Model Number 66800042 |
Device Problems
Connection Problem (2900); Premature Separation (4045)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/25/2022 |
Event Type
Injury
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Event Description
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It was reported that, during a debridement procedure, a versajet ii exact 45 degree 8mm handpiece fell out.In addition, the metal plug failed to connect to the console.Surgery was completed, after a 15 min delay, with a back-up handpiece.During this delay, the patient received additional anesthesia.
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Manufacturer Narrative
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The device was not returned for evaluation.A documentation review was performed.Historical review has revealed no other cases from the reported product or lot number, there are no open nor closed escalation actions within scope.Manufacturing records and associated processes detail no contributory factors, records reveal the device met the required specifications upon release into distribution.The associated risk files adequately mitigate the event.The instruction for use details the steps taken to fully engage the handpiece into the console.As the report details that the device became detached during debridement, initial connection can be discounted as a contributory factor.The probable cause remains unknown.Without the opportunity to evaluate the console or the handpiece no additional factors can be provided.No manufacturing quality concerns have been observed, therefore no corrective actions are deemed necessary.".
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Search Alerts/Recalls
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