NA ETHCB12LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888551018838), received between Dec 20, 2018 and Dec 20, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A TROCAR CANNULA STABILITY SLEEVE XCEL AND THE CUSTOMER BELIEVED THE DEVICE WAS NOT PROPERLY SANITIZED BECAUSE IT CONTAINED CONTAMINANTS. DURING PRE-OP, WHEN THE DEVICE WAS REMOVED THE PACKAGING THE ISSUE WAS NOTICED. THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. A NEW ALTERNATIVE DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE INTENT OF THE PROCEDURE WAS NOT ALTERED AS A RESULT. THERE WERE NO REPORTED PATIENT CONSEQUENCES. THIS EVENT HAS BEEN ASSESSED AS MDR REPORTABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8187888 ↗