Model Number IPN048386 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/06/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported "prior to intubation the hinge and light pipe were dislodged from the blade".Additional information states "per the anesthesia provider the blade split in half and the top part and light part fell off as well".No patient involvement reported.
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Event Description
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It was reported "prior to intubation the hinge and light pipe were dislodged from the blade".Additional information states "per the anesthesia provider the blade split in half and the top part and light part fell off as well".No patient involvement reported.
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Manufacturer Narrative
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(b)(4).The customer returned one 004551003 rusch greenlite disposable metal mac 3 for investigation.The blade was returned opened out of its original packaging with a rusch dispoled handle detached.Visual inspection of the returned sample revealed that the blade was broken as it was separated from the metal hinge connector.The light pipe was also found broken at the proximal end where it enters the metal connector.The device history record of lot 1902331 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.According to the manufacturing site, the observed defect is a known issue which is caused by an inadequate welding of the metal joints that hold the blade in place.Corrective actions were implemented in sep 2020 to address the weak welding issue.This device was manufactured in feb 2019, which is prior to the corrective actions.
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Search Alerts/Recalls
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