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Model Number 72202468 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/03/2018 |
Event Type
malfunction
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Event Description
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It was reported that on (b)(6) 2018, in the meniscal suturing operation at the (b)(6), the second hit, the line did not come out.No patient injury or significant time delay reported.
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Manufacturer Narrative
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One 72202468 fast-fix 360 curved needle delivery system device returned.Complaint stated: ¿the second hit, the line did not come out.¿ the device is in very poor condition.The depth limiter is attached.T1, t2 and suture were not returned.The delivery needle is disfigured.It is bowed, bent and twisted.The damage attained impedes the functional test.This device no longer cycles or actuates.The physical condition is indicative of a challenge to reach the desired surgical location.
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Search Alerts/Recalls
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