Model Number 0682400550 |
Device Problem
Electromagnetic Interference (1194)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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It was reported that an equipment boom electrical rotational brakes disengaged when a cauterizer device was being used during a procedure.There was patient involvement due to the issue occurring during a procedure but there was no impact to the patient and caused no surgical delay.They experienced the issue when the patient was closed up.There were no reported injuries or adverse consequences.A stryker field service technician (sfst) was dispatched to the account to perform an investigation.The sfst confirmed the failure with the customer but was unable to recreate the issue while on-site.The sfst observed that the equipment boom mfr assembly had the old-style revision of capacitive touch board although we couldn't confirm the root cause we suspect the issue is most likely due to the previous version of mfr capacitive board.The newer revision capacitive touch board was redesigned and released back in april 2020 to be less susceptible to emi from high frequency devices.The sfst was unable to install the newer mfr capacitive touch board due to parts being backordered, once parts are available we will install the redesigned capacitive touch board.If any further information around this event is obtained we will file a supplemental.
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Event Description
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It was reported the cautery was in use during a case and the boom brakes disengaged in or 6.There were no reported injuries or adverse consequences.
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Manufacturer Narrative
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It was reported that once parts were available, the stryker field service technician (sfst) installed our current released mfr board and confirmed that the boom was operational.
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Event Description
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It was reported the cautery was in use during a case and the boom brakes disengaged in or 6.There were no reported injuries or adverse consequences.
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Search Alerts/Recalls
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