It was reported that during surgery, the hose was tearing and coming apart.The unit was doing some type of burning.There was no patient harm/injury.There was an unspecified surgical delay.The hose was leaking air.There was no fire or smoke.Due diligence is complete, no further information is available.
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This event has been recorded by zimmer biomet under cmp-(b)(4).The following sections have been corrected/updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h4, h6, and h10.Review of the most recent repair record determined the hose was damaged.The hose was replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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