AESCULAP, INC. ROUND FILTERS W/INDICATOR; STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
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Model Number US751 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturing evaluation investigation on going.Additional information / investigation results will be provided in a supplemental report.
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Event Description
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It was reported that there was an issue with the round filters with indicators.It was found during an unspecified procedure, and caused an unspecified surgical delay.Details on the occurrence pin holes in filter have been requested.Additional information was not provided.
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Manufacturer Narrative
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Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.An investigation of the device manufacturing records was not able to be conducted by the manufacturer as the model # and lot # of the device in question was not known.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.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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Search Alerts/Recalls
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