TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS STERNAL SAW II; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL-SARNS STERNAL SAW SYSTEMS
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Model Number 15670 |
Device Problem
Disconnection (1171)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/23/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Per service repair supervisor, the unit is unrepairable since it reached end of service life (eosl) in 2018.Per the user facility's biomedical engineer, they will be replacing the drill motor with a new battery operated device.
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Event Description
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It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the power cable connection to the saw came apart.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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Manufacturer Narrative
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The reported complaint was confirmed via photo sent in by the user facility.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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Search Alerts/Recalls
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