TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS STERNAL SAW II; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL-SARNS STERNAL SAW SYSTEMS
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Model Number 15665 |
Device Problems
Component Missing (2306); Connection Problem (2900)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/29/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).End of service life met, no repairs available.Per the user facility, the device will not be returned to the manufacturer.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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Event Description
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It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the cable connector end was missing.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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Serial number should have been blank on the initial emdr submission.The reported complaint was not verifiable.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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