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 02/03/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation on-going.Should relevant additional / investigation results become available, a supplemental medwatch report will be submitted.
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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 not been returned to the manufacturer for evaluation.No patient involvement.
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Manufacturer Narrative
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Additional information - d4 (lot #) and d9.Manufacturer evaluation: the device was returned to the manufacturer for physical evaluation.Functional testing was performed by exposing twelve (12) 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 reviewed for the available lot number; the devices were found to be within specification at the time of production.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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