Catalog Number 8065752082 |
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 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 disconnection of an irrigation line multiple times during a surgery.The type of surgery was unknown.The product was replaced and the surgery was completed.There was no patient harm.
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Manufacturer Narrative
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The customer did not retain the product lot information for this procedure pack, therefore the device history records traceable to the reported procedure pack could not be reviewed.The used intrepid fms was visually inspected.The sample was tested using the infiniti console with the software.The fms primed and tuned with the ultrasonic handpiece successfully.No message code, no fluid or air leaks, and no cracks on the luers were found.No occlusion was found in all manifolds.The root cause of the customer's complaint could not be established; the returned sample met specifications.No contributing factors could be identified that could cause the customer¿s experience.After the investigation of this complaint, it has been determined that this sample met specifications.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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