Catalog Number 3539700 |
Device Problems
Loose or Intermittent Connection (1371); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
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Patient Problems
Tissue Damage (2104); Injury (2348); No Patient Involvement (2645)
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Event Date 02/27/2015 |
Event Type
Injury
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Event Description
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It was reported the dermatome harvested a full thickness graft.It was noted the screw in the dermatome guard had come loose.The screw was secured in place then the device began starting and stopping intermittently.The power supply was changed but the problem continued.Another device was opened and this dermatome was removed from service.It is reported the patient's status is unknown.
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Manufacturer Narrative
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The device involved in the reported incident is not expected to be received for evaluation.An investigation has been initiated based upon the reported information.
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Manufacturer Narrative
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Integra completed their internal investigation on 09/01/2015: product not released for inspection.Device history record reviewed for (b)(4) manufactured on 06/08/2004 show no abnormalities related to reported incident found.This device passed all required inspection points with no associated mfr¿s, variances or rework.No manufacturing or design related trend has been identified.Conclusion: in summary - the device was not released for evaluation therefore the root cause to the end users experience could not be determined.This complaint will be reopened should we receive product.
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Search Alerts/Recalls
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