Catalog Number UNK_ICO |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H6: a follow up report will be filed once the quality investigation is complete.H3: awaiting for device return to manufacturer.
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Event Description
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It was reported that during a surgical procedure, black substance leaked from the device.It was also reported there were no delays, no adverse consequences and no medical intervention as a result of this event.It was further reported that the procedure was completed successfully.
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Manufacturer Narrative
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H6: the quality investigation is complete.Product status unknown.
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Event Description
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It was reported that during a surgical procedure, black substance leaked from the device.It was also reported there were no delays, no adverse consequences and no medical intervention as a result of this event.It was further reported that the procedure was completed successfully.
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Search Alerts/Recalls
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