This is 1 of 4 reports linked to mfg report numbers: 3006697299-2022-00022, 3006697299-2022-00023, and 3006697299-2022-00024.A facility reported that the amplitude could not go up during fragmentation.They changed to a new tip and consumables.Cusa excel 36khz cem nosecone (c6636) device was involved, and surgical delay of 30-40 minutes was reported.There was no adverse patient consequence.
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The cusa excel 36khz cem nosecone (c6636) was not returned for evaluation due to blood contamination as per the customer; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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