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Model Number 66020626 |
Device Problem
Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/20/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal reference number: (b)(4).
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Event Description
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It was reported that, during treatment, the fourth layer of a profore kit lff case 8 became extremely difficult to unroll when getting down to the last 1/4 of the roll.Once apart it was stretched out and could not be used.Treatment was resumed, with a less than or equal to 30 minutes delay, with a back-up device.It is unknown if this happened before, during or after treatment.Patient was not injured as consequence of this problem.
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Manufacturer Narrative
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The device, used in treatment, has been returned and evaluated, there was no obvious visual issue, however, the functional evaluation confirmed the profore layer 4 was difficult to unwind.A relationship against the reported event has been established.A complaint history review confirmed further instances of this nature.A review of the manufacturing records confirmed the device was released according to specification.A further review of the manufacturing process was also performed, and a root cause of inadequate standard operating procedure has been assigned.Corrective action has been assigned regarding this event to reduce the probability of further reoccurrences.This investigation is now complete, smith + nephew will continue to monitor for any adverse trends relating to this product range.
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Search Alerts/Recalls
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