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Model Number 66800042 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/31/2022 |
Event Type
malfunction
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Event Description
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It was reported that, during debridement, two (2) versajet exact assy, 45 degree x 8mm have leaked water.Water line was splashing all around instead of direct line.Debridement was performed, after a delay of 30 minutes or less, with a sn back-up device.No harm to the patient or further complications reported.
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Manufacturer Narrative
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The device has not been returned for evaluation, meaning the reported event could not be confirmed.A documentation investigation has been conducted, finding previous complaints of this nature.A process review identified no evidence of a manufacturing deficiency.No historical escalations have been observed.Probable root cause of the reported failure may be a blockage in the handpiece caused by debris build up, which blocks saline, and should be carefully removed.This is outlined in the device instructions for use.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.
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Manufacturer Narrative
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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.Event may cause minor or temporary injury (e.G., delayed wound healing, maceration, etc.) requiring no or minor medical intervention.Event may require use of a backup device to continue therapy.This event did not lead to a death or serious injury, nor would it be likely to cause or contribute to a death or serious injury if it were to recur.This event is considered not reportable pursuant to 21 cfr §803.
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Search Alerts/Recalls
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