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 02/02/2016 |
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 the insulation cracked, compromised, broke, or breached.Insulscan failed.
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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 instrument was tested for cracks in which an insul scan test was performed and failed.The probable root causes are normal wear, improper sterilization methods, and user misuse.(b)(4).
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Event Description
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It was reported the insulation cracked, compromised, broke, or breached.Insulscan failed.
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Search Alerts/Recalls
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