ST. JUDE MEDICAL NEUROTHERM SL PREMIUM CURVED RF NEEDLE, 20G, 15CM; PROBE, RADIOFREQUENCY LESION
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Model Number SL-C1510-20 |
Device Problem
Material Separation (1562)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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The results, method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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During the procedure, two rf cannulas were used for a bilateral injection to the sij.While removing the rf cannula, part of the isolation of one of the cannulas was ripped and remained in the body of the patient.The piece was unable to be felt through the skin and it was thought to have been within the deeper tissue.The patient was discharged in stable condition with no adverse patient consequences.
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Manufacturer Narrative
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One 15 cm, 20 g neurotherm rf needle was received for evaluation.One image was also submitted showing the needle with torn white material.Based on the information presented above, the curved active tip had part of its isolation ripped off.Unit analysis was completed and confirmed that the white insulation material was torn and detached from the cannula needle.During abbott process there are no cutting methods that could potentially rip the insulation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn insulation remains unknown.
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Search Alerts/Recalls
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