Catalog Number 0375544000 |
Device Problems
Bent (1059); Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/28/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.(b)(4).
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Event Description
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It was reported that blade got tangled up with tissue and the tip bent inside the patient, the tip broke after removal from the joint. there were no broken pieces inside the patient and no other adverse consequences reported.
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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.The reported failure mode will be monitored for future reoccurrence.Alleged failure: tip bent.Probable root cause: inadequate window profile.Inadequate welding process.Improper material strength.Inadequate size selected for the application.Material brittleness.Excessive force applied by the user.Incorrect rfid tag.Gtin: (b)(4).
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Event Description
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It was reported that blade got tangled up with tissue and the tip bent inside the patient, the tip broke after removal from the joint. there were no broken pieces inside the patient and no other adverse consequences reported.
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Search Alerts/Recalls
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