Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.Device history record: no anomalies that could be associated with the complaint incident was observed.Cusa excel straight handpiece (product id c2602) was returned for evaluation.The reported complaint was confirmed.Complaint is consistent with transducer delamination failures based on the following: 1.Date of manufacture 2019, 2.Confirmed tip test fail.Amplitude < 10%.3.Confirmed defective transducer.A corrective action is in progress for failures specific to excel hp transducer delamination failures manufactured at integra lifesciences.
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