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Model Number 9735560 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The fiber was returned to the manufacture for evaluation.After visual/physical examination the reported issue was not confirmed.The returned tubing had no apparent physical damage.Not able to confirm the reported failure.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information regarding a thermal therapy system being used in a soft tissue ablation (neuro) procedure.It was reported that the short section of tubing had a leak near the male connector.Not a pinhole, more like a slow drip similar to if the connection wasn¿t tight, but behind the connector instead of between them. there was a reported delay of under five minutes while the tubing set was replaced.There was no reported impact to the patient.
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Search Alerts/Recalls
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