YelloPort Plus - Laparoscopic Port Access System YC1210522Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05051986001418), received between Nov 27, 2017 and Nov 27, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (1 report).

1 other recall cover devices cleared under the same FDA submission (K070712); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionNov 27, 2017Crack

  A DISTRIBUTOR REPORTED A COMPLAINT THAT AN END USER NOTICED A CRACK ON THE TIP OF A CANNULA. THE DISTRIBUTOR STATED THAT A PIECE MAY HAVE BEEN DROPPED INSIDE OF THE PATIENT, AN XRAY WAS CARRIED OUT BUT THE PIECE COULD NOT BE FOUND. THE END USER HAS CONFIRMED THAT THE DEVICE WAS CHECKED PRIOR TO STERILISATION AND THERE WAS NO DAMAGE PRESENT, DEVICES ARE NOT CHECKED PRIOR TO USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7058441 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070712. One submission often covers many models, so check the product and lot details in each record.

• Z-1853-2022 · Jan 20, 2022 · Open, Classified
  Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.