Model Number 75-6540/20 |
Device Problem
Break (1069)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 04/05/2018 |
Event Type
malfunction
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Event Description
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The tip of the micropituitary ronguer broke off at its jaw during the procedure.Entire surgical team was made aware.A replacement rongeur was requested and brought into the room.A portion of the instrument was seen on x-ray by attending surgeon.Attempts were made to retrieve the part but was sitting deep inside the disc space.Artifact was felt to be in a safe position and was left.Patient and family were made aware of the incident.
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Event Description
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The tip of the micropituitary ronguer broke off at its jaw during the procedure.Entire surgical team was made aware.A replacement rongeur was requested and brought into the room.A portion of the instrument was seen on x-ray by attending surgeon.Attempts were made to retrieve the part but was sitting deep inside the disc space.Artifact was felt to be in a safe position and was left.Patient and family were made aware of the incident.
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Event Description
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The tip of the micropituitary ronguer broke off at its jaw during the procedure.Entire surgical team was made aware.A replacement rongeur was requested and brought into the room.A portion of the instrument was seen on x-ray by attending surgeon.Attempts were made to retrieve the part but was sitting deep inside the disc space.Artifact was felt to be in a safe position and was left.Patient and family were made aware of the incident.
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Manufacturer Narrative
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The following elements have blank data: device manufacturer's street address: (line 1) for type of device: rongeur.City: for type of device: rongeur.State: for type of device: rongeur.Zip: for type of device: rongeur.
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Event Description
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The tip of the micropituitary ronguer broke off at its jaw during the procedure.Entire surgical team was made aware.A replacement rongeur was requested and brought into the room.A portion of the instrument was seen on x-ray by attending surgeon.Attempts were made to retrieve the part but was sitting deep inside the disc space.Artifact was felt to be in a safe position and was left.Patient and family were made aware of the incident.
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Event Description
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The tip of the micropituitary ronguer broke off at its jaw during the procedure.Entire surgical team was made aware.A replacement rongeur was requested and brought into the room.A portion of the instrument was seen on x-ray by attending surgeon.Attempts were made to retrieve the part but was sitting deep inside the disc space.Artifact was felt to be in a safe position and was left.Patient and family were made aware of the incident.
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Manufacturer Narrative
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The following elements have blank data.
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Manufacturer Narrative
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The following elements have blank data.
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Event Description
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The tip of the micropituitary ronguer broke off at its jaw during the procedure.Entire surgical team was made aware.A replacement rongeur was requested and brought into the room.A portion of the instrument was seen on x-ray by attending surgeon.Attempts were made to retrieve the part but was sitting deep inside the disc space.Artifact was felt to be in a safe position and was left.Patient and family were made aware of the incident.
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Search Alerts/Recalls
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