It was reported that the customer received a partial order of quite a few goodwin sound replacements as it had consistently had issues with rust 042822 and 042820 and discoloration 042816 and 042814 in the lumen.It was also stated upon receiving the new replacements, they were inspected with a borescope and discoloration was noted prior to any reprocessing.Per follow up via email on 16aug2021, the lot numbers of the affected sounds which are mixed with new box and never processed.The new box, which was processed initially, never used on patient.This was the ongoing issue for the customer and consistently replacing these.The customer checked and verified internal process and follow the ifu verbatim, flushing with sterile water at point of use.The box and packaging that customer received was for 11 sounds.They have total of 24 sounds 042824 and 042826.
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The reported event was unconfirmed because the reported failure could not be reproduced.The device did not fail to meet relevant specifications.As the product was not used on a patient it was not used for diagnostic or treatment purposes.The product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.One, 26 fr sound dilator was returned.No rusting or discoloration was noted.Device meets specifications which states, "surface must have a mirror bright finish".A photo sample was also returned.No rust or discoloration was noted.The lot number was unknown; therefore, the device history record could not be reviewed.Labeling review is not required as the reported event is unconfirmed.The actual/suspected device was inspected.
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