The cusa excel 36khz standardtip straight (c4613s) was not returned for evaluation as per customer, the device was blood contaminated; 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.Without the return of the product for an alleged functional issue such as this, the complaint is unable to be confirmed, and root cause determination is not possible.No further investigation required based on the acceptability of risk.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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This is 3 of 4 reports linked to mfg report numbers: 3006697299-2022-00021, 3006697299-2022-00022, 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 standardtip straight (c4613s) was involved, and surgical delay of 30-40 minutes was reported.There was no adverse patient consequence.
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