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Model Number 66800042 |
Device Problems
Fluid/Blood Leak (1250); Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/31/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that during treatment a cable came loose with a high pressure leak.The canisters (jar) used to collect the water and debris residue has multiple valves, the user forgot to open the valves, so a vacuum was created.The force created a high pressure leak.There was a delay greater than 30 minutes, backup was available and used.No patient harm was reported.
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Manufacturer Narrative
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The device, used in treatment, was not returned for evaluation.A photo was provided for review and we could establish a relationship between the reported event and the device.The root cause was determined to be user error as stated in the complaint, the user forgot to open the valves causing the failure.A review of the manufacturing records could not be performed because the lot number was not provided.The complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary.We will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
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Search Alerts/Recalls
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