YelloPort Plus - Laparoscopic Port Access System YA05VSS01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05051986002347), received between Jul 23, 2018 and Jul 30, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Material Fragmentation

  Description: During the closure phase of the TAPP procedure, a missing valve was noticed; a search for the missing part was conducted but it was not found within the abdominal cavity, and the abdomen was closed.The patient is to be kept under observation. The valve has been discarded.Combined equipment: Forceps by STORZ.Confirmed: The valve was damaged during the surgery, and a part of the valve was missing. Also, the damaged valve was discarded in the hospital.Conclusion after investigation: Based on previous complaint investigations, this failure mode has only been observed where instrument tips were slightly open during insertion and subsequently pushed through the valve, resulting in a tear. Given the consistency of this failure mechanism with previous investigations, the root cause is concluded to be user error during instrument insertion. Given the frequency of reported events over the previous 12 months, a CAPA will be raised to further investigate this issue and implement appropriate measures to prevent future occurrences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50082146 ↗
• MalfunctionOct 21, 2020Material Separation

  BEFORE THE LAP PROCEDURE, NURSE OPENED THE PACKAGE AS USUAL AND CHECKED THE VALVE BRIEFLY. HOWEVER, AFTER THE PROCEDURE COMPLETED, THE NURSE DISSEMBLED THE REUSABLE AND DISPOSABLE PARTS OF TROCAR, SHE FOUND THERE WAS MISSING PORTION ON THAT VALVE AND THEY COULDN'T FIND IT ANYWHERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10710626 ↗
• MalfunctionNov 5, 2019Break; Melted

  DURING SURGERY, A PROBE WAS INSERTED, AND PULLED OUT THROUGH YA05VSS01 SILICONE VALVE, AND OUR CUSTOMER FOUND THE PRODUCT WAS MELTED, AND BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9279092 ↗
• MalfunctionJul 23, 2018Break; Gas/Air Leak

  DURING A PROCEDURE, THE DOCTOR CONFIRMED AIR LEAKAGE AND THE VALVE WAS DAMAGED. IT HAPPENED 5MINS AFTER THE BEGINNING OF SURGERY. HE/ SHE USED A GRASPING FORCEPS AND INSERTED JUST ONCE. THE USER COULD NOT FIND THE BROKEN PARTS. DURING A PROCEDURE, THE DOCTOR CONFIRMED AIR LEAKAGE AND THE VALVE WAS DAMAGED. IT HAPPENED 5MINS AFTER THE BEGINNING OF SURGERY. HE/ SHE USED A GRASPING FORCEPS AND INSERTED JUST ONCE. THE USER COULD NOT FIND THE BROKEN PARTS.

  Patient problems: No Information

  MAUDE report 7709657 ↗

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.