Model Number US906 |
Device Problem
Unexpected Color (4055)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/24/2022 |
Event Type
malfunction
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Event Description
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It was reported to aesculap inc.That a steam ster locks orange (part # us906) was used to secure a sterilization container.According to the complainant, while in the sterile processing department (spd), the indicator dot failed to transition to its post sterilization color.The complaint device has been returned to the manufacturer for evaluation.No patient involvement.
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Manufacturer Narrative
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Manufacturer evaluation: investigation on-going.Should relevant additional / investigation results become available, a supplemental medwatch report will be submitted.
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Manufacturer Narrative
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Manufacturer evaluation: the device was returned to the manufacturer for physical evaluation.Functional testing was performed by exposing fifty (50) of the locks to steam cycles.A visual examination of the chemical indicator revealed that all dots transitioned from blue to brown.The device history records (dhr) were not able to be reviewed as no lot # was made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.The investigation into the cause of the reported problem was not able to confirm the failure mode of chemical indicator failed to transition to its post sterilization color.
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Search Alerts/Recalls
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