H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.The lot met all release criteria.Investigation summary: a review of the sterilization records and bioburden identified that the lot met all sterile release criteria and no unacceptable bioburden results were identified.A lot sample was returned and tested using the wep tester at 3.5psi.No water was observed to be leaking from the device.Based on the available information, the most likely root cause is patient and/or procedural related.The investigation is inconclusive.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
|