TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERNAL SAW II BLADE; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL-SARNS STERNAL SAW SYSTEMS
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Model Number 5590 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/29/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Evaluation is in progress, but not yet concluded.
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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 device had a bent blade.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.The service repair technician duplicated the reported complaint and noted that the protector needs to be replaced.The sternal saw will not be repaired due to it has reached the end of service life.The unit does not meet the manufacturer's specifications.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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