Catalog Number 0207050000 |
Device Problem
Disassembly (1168)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/03/2014 |
Event Type
malfunction
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Event Description
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It was reported that the surgilav plus handpiece set was being used in a procedure when the tip broke off and came out of the gun.It was confirmed that the tip did not fall into the surgical site.The procedure was completed successfully, with no patient or user injuries and no adverse consequences.
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Manufacturer Narrative
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A follow up report will be filed after the device is received and the quality investigation has been completed.
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Event Description
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It was reported that the surgilav plus handpiece set was being used in a procedure when the tip broke off and came out of the gun.It was confirmed that the tip did not fall into the surgical site.The procedure was completed successfully, with no patient or user injuries and no adverse consequences.
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Manufacturer Narrative
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The device evaluated and no failures were detected.It was confirmed that this product is concomitant to manufacturer report number 0001811755-2014-02308 for the fan spray tip with soft cone splash shield.An additional supplemental report will be filed on stryker reference number (b)(4) for the fan spray tip with soft cone splash shield to add this product.
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Search Alerts/Recalls
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