Catalog Number 0250181106 |
Device Problems
Break (1069); Crack (1135); 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 03/04/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported the shaft insulation cracked, compromized, broke or breached.
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Manufacturer Narrative
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(b)(4).The device manufacture date is not known, lot number could not be confirmed.The product was returned and the failure mode was confirmed.Cracks were seen on the insulation and failed the insulin scan test.The probable root causes are normal wear, improper sterilization methods, and user misuse.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported the shaft insulation cracked, compromized, broke or breached.
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Search Alerts/Recalls
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