Model Number OM-9000Z |
Device Problems
Mechanical Problem (1384); Suction Failure (4039)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise id (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.H3 other text : device not returned.
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Event Description
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The hospital reported that during a coronary artery bypass procedure using acrobat suv stabilizer system om-9000z, they tried to fix it to the anastomosis site of the coronary artery, but it could not be fixed because the suction pressure was minus 400mmhg.It did not adsorb.It is considered that there was a problem with the suction.Swivel is no problem.The retractor lock was fine.Surgery was completed using the new om-9000z.No procedural delay.There were no effects on patients.
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Manufacturer Narrative
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Trackwise # (b)(4).The lot # 3000269996 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
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Manufacturer Narrative
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(b)(4).Corrected sections: h6--problem code corrected from "1384" to "4039".
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Event Description
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N/a.
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Search Alerts/Recalls
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