Model Number 989803137631 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Tissue Damage (2104)
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Event Type
Injury
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Manufacturer Narrative
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A follow up report will be submitted once the investigation is complete.Initial reporter phone number: (b)(6).
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Event Description
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The customer reported the tip of the (b)(4) fetal spiral electrode remained under the baby's scalp during removal and was not noticed by the staff.A week later the baby was examined for a sore spot on the scalp.The metal tip was surgically removed.The patient did sustain a wound to the scalp which was treated.
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Manufacturer Narrative
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The customer reported the tip of the (b)(4) fetal spiral electrode remained under the baby's scalp during removal and was not noticed by the staff.A week later the baby was examined for a sore spot on the scalp.The metal tip was surgically removed.The patient did sustain a wound to the scalp which was treated.As the result of this event, the customer was provided training on the use of the fetal spiral electrode by a philips representative.The ifu for the fse (b)(4) states in a warning not to over rotate the fse.It was reported that the customer had discarded the fse assembly and the fragment was not available for evaluation.The date of the incident was not provided.
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Search Alerts/Recalls
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