STRYKER ENDOSCOPY-SAN JOSE PKG., AGG. PLUS SHAVER BLADE, F- SERIES - 4.0MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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Catalog Number 0375544000 |
Device Problems
Break (1069); Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/09/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The product was not returned for investigation; therefore, the reported failure mode was not confirmed.Alleged failure: blade broke off.Probable root cause: inadequate window profile.Inadequate welding process (i.E.Plasma, inductive, gluing).Improper material strength.Inadequate size selected for the application.Material brittleness.Excessive force applied by the user.Incorrect rfid tag.The reported failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that the tip broke during a case.It was confirmed by the sales rep that the blade was not oscillating like usual and began to break, but no pieces broke inside the patient.
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Search Alerts/Recalls
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