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Model Number AIRSEAL IFS |
Device Problems
Device Emits Odor (1425); Incorrect, Inadequate or Imprecise Result or Readings (1535); Smoking (1585)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/06/2020 |
Event Type
malfunction
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Event Description
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Electrical burning smell noted in operating room 4 during procedure.Hazy light smoke coming from back of airseal unit.Airseal turned off and unplugged.Airseal marked out of service.Manufacturer response for insufflator, airseal ifs (per site reporter).This is part of the wear and tear.It is an identified assembly issue of the device.Such assembly corrected by manufacturer for models after 2017.Power entry module failure.Manufacturer will not consider this as a serious issue, their action was to replace the failing module and not addressing the possibility that it would happen again.
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Event Description
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Electrical burning smell noted in or4 during procedure.Hazy light smoke coming from back of airseal unit.Airseal turned off and unplugged.Airseal marked out of service.Manufacturer response for insufflator, airseal ifs (per site reporter).This is part of the wear and tear.It is an identified assembly issue of the device.Such assembly corrected by manufacturer for models after 2017.Power entry module failure.Manufacturer will not consider this as a serious issue, their action was to replace the failing module and not addressing the possibility that it would happen again.
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Search Alerts/Recalls
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