TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS STERNAL SAW SYSTEMS; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL-SARNS STERNAL SAW SYSTEMS
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Model Number 5590 |
Device Problems
Failure To Service (1563); Maintenance Does Not Comply To Manufacturers Recommendations (2974)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).This complaint is related to emdr #1828100-2016-00210.The reported complaint was confirmed.The sternal saw drive components were worn due to lack of preventive maintenance (pm) and lubrication.Per the instructions for use (ifu), the sternal saw must have pm every six months for optimum operation.The srt replaced the cam/gear assembly and performed verification / release testing of the sternal saw.The unit operated to manufacturer specifications and was returned to clinical use.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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The service repair technician (srt) reported that during routine testing of the device at the service center, the cam/gear assembly has faulty bearings of the sternal saw (does not rotate smoothly).There was no patient involvement.
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Search Alerts/Recalls
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