Model Number 173016 |
Device Problems
Detachment Of Device Component (1104); Human-Device Interface Problem (2949)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during a procedure, the device was difficult to toggle, load and unload.The device was hard to operate.Two different needles fell out of the jaw when it was properly loaded and in the locked position.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Device had bent blades.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.Replication of the bent blade indicates that the instrument may have been exposed to an external force which bent the exposed metal bars.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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