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Model Number 4986 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/08/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during set up or inspection, it was impossible to remove the release paper of the opsite because it adhered to the film strongly.The procedure was completed without a significant delay using a smith & nephew back-up device.No other complications were reported.
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Manufacturer Narrative
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We have now concluded our investigation for the complaint received.The device intended to be used in treatment has been returned and evaluated.A relationship between the event and the device was confirmed.An initial visual inspection confirmed that the pouch was completely sealed all around.The root cause was determined as the paper slightly moving backward when the machine start-up or restart, causing the cutting position to fall in the sealed area.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances of the reported events.The machine start parameter setting had been optimized to avoid the above issue.No further actions are deemed necessary at this stage.We will continue to monitor for any adverse trends relating to this product range.Smith and 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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