Event 1: it was reported to aesculap inc.That a round filters w/indicator (part# us751) was used with a sterilization container provided for use during an unspecified surgical procedure on (b)(6) 2023.According to the complainant the or staff found small holes in the sterile container filters.Reportedly this caused a delay in the surgical procedure.The adverse event is filed under aic reference (b)(4), (b)(6).Associated medwatch reports: (b)(6), (2916714-2023-00134), us751, event 2.(b)(6), (2916714-2023-00135), us751, event 3.(b)(6), (2916714-2023-00136), us751, event 4.(b)(6), (2916714-2023-00137), us751, event 5.(b)(6), (2916714-2023-00138), us751, event 6.(b)(6), (2916714-2023-00139), us751, event 7.(b)(6), (2916714-2023-00140), us751, event 1.(b)(6), (2916714-2023-00141), us751, event 2.
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Event 1 additional information: h6 codes updated.D9 returned to manufacturer.Investigation results: the device record cannot be evaluated due to lack of lot code information.The samples that were returned, no visible micro pinholes.No further action will be taken at this time, not a manufacturing defect.Root cause investigation: customer was asked how they are evaluating the product, response "by putting up to the light or in the or and seeing if they can see any pinholes.They were actually rejecting sets based on shades of color in the filters to but i pointed out to them this was overkill" this is not the proper way to evaluate the pinholes, the changes in color if filter material is expected.
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