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Model Number V5 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 02/21/2024 |
Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2023, a novasure procedure was performed and after the procedure, the cervical seal was left inside the patient.The seal was removed from the patient with forceps.No complications reported to the patient.No additional information available.
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Manufacturer Narrative
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D4: lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.H3: the device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
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Search Alerts/Recalls
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