YelloPort Elite - Laparoscopic Port Access System EA12NHRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05051986012117), received between Nov 1, 2021 and Mar 3, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K190592); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2022Device Markings/Labelling Problem

  DEVICE WITH INCORRECT STERILITY STATUS DISCOVERED DURING CONTAINMENT ACTIVITY AT MANUFACTURER (SURGICAL INNOVATIONS LTD) DURING INVESTIGATIONS OF CUSTOMER COMPLAINT (B)(4). DEVICES ARE MARKED AS 'STERILE' SINGLE-USE BUT ARE NON-STERILE REUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13659006 ↗
• MalfunctionNov 1, 2021Product Quality Problem

  CUSTOMER COMPLAINED THAT THE DEVICE WAS NOW LABELLED AS 'SINGLE-USE' WHEREAS PREVIOUS PURCHASES OF THE SAME DEVICE HAD NOT BEEN LABELLED AS 'SINGLE-USE'.

  Patient problems: Insufficient Information

  MAUDE report 12728365 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190592. One submission often covers many models, so check the product and lot details in each record.

• Z-1396-2022 · Jun 2, 2022 · Completed
  YelloPort Elite Universal Seal. For use in laparoscopic procedures.
• Z-1852-2022 · Jan 20, 2022 · Open, Classified
  Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.