Model Number 0279401200 |
Device Problems
Continuous Firing (1123); Self-Activation or Keying (1557)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that the device continuously activated.
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Manufacturer Narrative
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The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: serfas wand activated without the buttons being pushed on the hand control or the foot pedal the probable root cause/s could be probe short due to fluid ingress.A broken/damaged bond of the polyimide and suction tubing causes fluid ingress to the pcb which can lead to a short circuit.The failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that the device continuously activated.
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Search Alerts/Recalls
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