Model Number 1910-2000 |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Upon completion of investigation, additional information will be provided in a supplemental report.
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Event Description
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It was reported that for a procedure to place sonic anchors in the patient's right foot, it was discovered that the 3-prong socket in the back of the generator was sunken in and the unit would not turn on.Competitor anchors were used to complete the case successfully with a delay of approximately 5 minutes.
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Event Description
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It was reported that for a procedure to place sonic anchors in the patient's right foot, it was discovered that the 3-prong socket in the back of the generator was sunken in and the unit would not turn on.Competitor anchors were used to complete the case successfully with a delay of approximately 5 minutes.
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Manufacturer Narrative
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The failure(s) identified in the investigation is consistent with the complaint record.The device was examined by the producer stryker endoscopy, san josé (ca), stryker t&e does neither have the equipment nor the electronics specialists for a comprehensive inspection of the generator.Results: visual inspection: the sonicfusion console was received with half of the warranty seal missing.External damages were noticed during visual inspection.Functional inspection: then a power cable was plugged in but the console was unable to power on.Using a multimeter the fuses were verified to have continuity.The main board was inspected and confirmed damage to power inlet.The root cause could be possible user misuse.Pac: review of capa database and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated potential non-function was addressed adequately.There is already one ongoing action in place related to the reported event for the subject product.
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Search Alerts/Recalls
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