Model Number W-203-B(EC) |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/24/2022 |
Event Type
malfunction
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Event Description
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It was reported that, when opening a versapulse-disposable pulse lavag suction box during the set-up for a tka surgery, it was found that both sterile packaging had been opened already.Surgery was resumed, without any delay, with a competitor's device (pulse lavage from zimmer - pulsavac).Patient was not injured as consequence of this problem.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).
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Event Description
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It was reported that, when opening a versapulse-disposble pulse lavag suction box during the set-up for a tka surgery, it was found that both sterile packaging had been opened already.Surgery was resumed, without any delay, with a competitor's device (pulse lavage from zimmer - pulsavac).Patient was not injured as consequence of this problem.
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Event Description
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It was reported that, when opening two (2) versapulse-disposble pulse lavag suction boxes during the set-up for a tka surgery, it was found that both sterile packaging had been opened already.Surgery was resumed, without any delay, with a competitor's device (pulse lavage from zimmer - pulsavac).Patient was not injured as consequence of this problem.
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).
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Manufacturer Narrative
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H10: this event was re-evaluated for mdr reporting.Smith+nephew does not have reporting responsibilities for this product; therefore, guangzhou, the legal manufacturer, is responsible for performing the regulatory assessment and reporting to any nca if required.
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Search Alerts/Recalls
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