Catalog Number 0703047000 |
Device Problem
Device Remains Activated (1525)
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Patient Problem
Superficial (First Degree) Burn (2685)
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Event Date 10/13/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A follow-up report will be filed once the quality investigation is complete.Awaiting device return.
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Event Description
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It was reported that during a procedure, the pencil stayed on when not in use.It was also reported that there was a burn on patients left breast, no blistering, just discoloration from the burn, no further intervention needed, no permanent damage, no infection.It was further reported that there was a no surgical delay and the procedure was completed successfully.
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Event Description
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It was reported that during a procedure, the pencil stayed on when not in use.It was also reported that there was a burn on patients left breast, no blistering, just discoloration from the burn, no further intervention needed, no permanent damage, no infection.It was further reported that there was a no surgical delay and the procedure was completed successfully.
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Manufacturer Narrative
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H6: the quality investigation is complete.H3 other text : device not returned.
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Event Description
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It was reported that during a procedure, the pencil stayed on when not in use.It was also reported that there was a burn on patients left breast, no blistering, just discoloration from the burn, no further intervention needed, no permanent damage, no infection.It was further reported that there was a no surgical delay and the procedure was completed successfully.
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Manufacturer Narrative
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D9/h3: the device was subsequently returned and evaluated.H6: the quality investigation is complete.
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Search Alerts/Recalls
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