YelloPort Plus - Laparoscopic Port Access System YA512STSARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05051986004921), received between Nov 27, 2017 and Oct 1, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2020Material Split, Cut or Torn

  DAMAGE AND TEARING OF THE 12MM AND 10MM SEALS ON SWINGTOP. FROM PHOTOGRAPH OF THE DEVICE, PARTS OF THE BLUE 10MM AND RED 12MM SEALS ARE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10612047 ↗
• MalfunctionNov 27, 2017Device Markings/Labelling Problem

  A DISTRIBUTOR REPORTED THAT THEY RECIEVED SOME DEVICES LABELLED (PRIMARY PACKAGING) AS NON-STERILE AND THE SECONDARY PACKAGING WAS LABELLED AS STERILE. THE DEVICE SUPPLIED TO THE DISTRIBUTOR IS A STERILE DEVICE. THE ISSUE WAS DISCOVERED DURING STOCK INVENTORY. THE DISTRIBUTOR HAS CONFIRMED, TO THE BEST OF THEIR KNOWLEDGE NO PRODUCT LABELLED AS NON-STERILE WAS USED IN A CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7058460 ↗
• MalfunctionNov 27, 2017Component Missing; Device Or Device Fragments Location Unknown

  A DISTRIBUTOR REPORTED THAT A CUSTOMER NOTICED A PIECE MISSING ON A SWINGTOP DEVICE AFTER 3 HOURS OF OPERATION. THE DOCTOR USED A 10MM STORTZ CAMERA SCOPE INSTRUMENT WITH THE DEVICE. AN XRAY WAS CARRIED OUT TO LOCATE THE MISSING PIECE INSIDE THE PATIENT, THE PIECE WAS NOT FOUND.

  Patient problems: No Code Available

  MAUDE report 7058435 ↗

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.