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(b)(4).Date sent: 7/21/2025.B3: event year only reported: 2025.D4 batch #: x9680m.Additional information was requested and the following was obtained: did the patient experience any adverse consequences due to this issue? there were no consequences for the patient, except a delay in management in the block and stress generated at the level of the operating team.Investigation summary: the handpiece hp054 was received disassembled, the nose cone was returned apart cracked.No functional testing could be done due to the condition of the returned device.No damaged at the cable nor the insulation was noted as reported.The end cap was disassembled to inspect remaining components.The moisture indicator was positive and the internal wires disconnected.¿positive moisture indicator¿ describes a condition where water enters the handpiece cavity during the steam sterilization process due to the damaged nose cone.Analysis was unable to determine the exact root cause that lead to crack in the hand piece nosecone.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.It is probable that the ingress of moisture affected handpiece functionality.A manufacturing record evaluation was performed for the finished device batch x9680m, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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