Catalog Number 0375704500E |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/22/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that the product heated up.
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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: the practitioner broke 2 strawberries during use.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.The failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that the product heated up.
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Search Alerts/Recalls
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