Cook G55788Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002557888), received between Aug 25, 2024 and Aug 26, 2024 — classified as 2 malfunctions.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2024Material Disintegration; Scratched Material; Material Disintegration; Scratched Material

  DURING AN EGG RETRIEVAL THE USER FOUND SOME PLASTICS IN THE FLUID. THEY SAVED THE NEEDLE AND PIECES OF PLASTICS FOR EVALUATION. THE USER THOUGHT IT WAS MAYBE THE TUBES WERE DOING IT BUT THAT WOULDN¿T EXPLAIN LAST WEEK'S PROBLEM [PR(B)(4)]. ADDITIONAL INFORMATION RECEIVED 20TH AUG 2024: "I WAS THE EMBRYOLOGIST WHO SAW THE SHARDS OF PLASTIC IN THE FOLLICULAR FLUID FOR THE INCIDENT ON AUGUST 12TH. THE REASON THIS CAUGHT MY EYE WAS THAT THE PLASTIC SHARDS WERE BURIED IN THE CELLS (CUMULUS CELLS) AROUND THE EGG. I NOTICED THE SHARDS BEFORE I PICKED UP THE EGG WITH MY PIPET SO I KNOW THEY WERE THERE BEFORE I HAD A CHANCE TO HANDLE THE EGG. I ALSO SAW SMALL SHARDS OF PLASTIC FLOATING IN THE DISH OF FLUID. I INCLUDED THOSE SHARDS AS WELL AS THE CUMULUS THAT WAS CUT OFF THE EGG IN THE SAMPLES THAT WERE SENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20071980 ↗
• MalfunctionAug 25, 2024Material Disintegration; Scratched Material; Material Disintegration; Scratched Material

  AFTER AN IVF RETRIEVAL, A PIECE OF PLASTIC WAS SEEN AS THE LAB WAS LOOKING THROUGH THE FLUID UNDER MICROSCOPE. THE NEEDLE HAS ALREADY BEEN PUT IN THE SHARPS BOX SO THERE IS NO WAY OF KNOWING WHICH ONE WE USED TODAY. THE LOT # A1153708 AND IT WAS THE OVUM ASPIRATION NEEDLE DOUBLE LUMEN REF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20061135 ↗