Catalog Number 0250181108 |
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 shaft insulation is cracked, compromised, broke or breached.
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Manufacturer Narrative
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The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Dents and scratches were seen on the insulation.The lot# and pn etchings are not present.The instrument was tested for cracks and failed the insul scant test.The probable root causes are normal wear, improper sterilization methods, and user misuse.The device manufacture date is not known.(b)(4).
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Event Description
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It was reported shaft insulation is cracked, compromised, broke or breached.
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Search Alerts/Recalls
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