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Model Number PROFORE KIT LATEX FREE |
Device Problems
Mechanical Problem (1384); Material Integrity Problem (2978)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/22/2020 |
Event Type
malfunction
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Event Description
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It was reported that during set up the coband layer were found to stick together and very difficult to pull apart.The product was not used on the patient and a back-up was available to continue the treatment.There was no delay and no patient harm was reported.
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Manufacturer Narrative
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The device intended for use in treatment was not returned for evaluation, all provided information has been reviewed and we have not been able to establish a relationship between the reported event or determine a root cause.This investigation has not been able to determine a definitive root cause, however factors that can contribute to the reported issues are temperature fluctuation during transport and storage.If the material is subject to temperature fluctuations then this can affect the use.No batch/lot number has been provided, therefore a review of the device history has not been possible.A complaint history review found other related events.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.G1.
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Manufacturer Narrative
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H3, h6: the device, intended for use in treatment, has been returned for evaluation.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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Manufacturer Narrative
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H3, h6: the device, intended use in treatment, has been returned for evaluation.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.H3, h6, h10.
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Search Alerts/Recalls
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