Model Number 36703 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/19/2022 |
Event Type
malfunction
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Event Description
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It was reported that insufficient roll off occurred.A soloist single needle electrode was selected for the radiofrequency ablation of an osteoid osteoma.A 13 gauge x 10cm bone biopsy needle was placed on the nidus and the soloist needle was passed through it.Ablation was started and ran for 15 minutes.After 15 minutes, impedance was not achieved and ablation was restarted.Impedance was unable to be achieved during the second attempt.The soloist needle was repositioned but impedance could not be achieved.The needle was removed and the procedure was completed with another device.There were no patient complications reported.
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Event Description
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It was reported that insufficient roll off occurred.A soloist single needle electrode was selected for the radiofrequency ablation of an osteoid osteoma.A 13 gauge x 10cm bone biopsy needle was placed on the nidus and the soloist needle was passed through it.Ablation was started and ran for 15 minutes.After 15 minutes, impedance was not achieved and ablation was restarted.Impedance was unable to be achieved during the second attempt.The soloist needle was repositioned but impedance could not be achieved.The needle was removed and the procedure was completed with another device.There were no patient complications reported.
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Manufacturer Narrative
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Device evaluated by mfr: one electrode needle was returned for analysis and its respective connection cable.No visual damages defects were observed on the electrode needle.An electrical evaluation was performed by measuring the continuity, the electrode was able to conduct current indicating proper connectivity.
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Search Alerts/Recalls
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