NA 214108Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705003495), received between May 20, 2020 and Sep 15, 2026 — classified as 1 injury, 2 malfunctions.

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

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

• MalfunctionSep 15, 2026Crack; Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779226 ↗
• MalfunctionSep 10, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY THE SALES REP IN THAILAND THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 IT WAS DISCOVERED THAT THE EXPIRY DATE ON THE CARTON BOX OF THE CLEARCANNULA-THREADED 5.5MMX75MM 5PK -ST WAS NOT SAME AS THE EXPIRY DATE ON THE ITEM. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20178615 ↗
• InjuryMay 20, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED BY AFFILIATE VIA PERSONAL INTERACTION THE CLEARCANNULA-THREADED 5.5MMX75MM 5PK -ST. WHEN THE CANNULA (214108) WAS INSERTED, THE ASSISTANT SURGEON SAID THAT HE MIGHT HAVE NOTICED A CHIPPED ORANGE FRAGMENT OF THE CANNULA. ALTHOUGH THEY TRIED TO LOCATE THE FRAGMENT BY SEARCHING AROUND THE LESION WITH THE HELP OF A CAMERA, A LARGE AMOUNT OF SYNOVIUM HINDERED THE SEARCHING. THEY COMPLETED THE PROCEDURE AS SCHEDULED WITHOUT FINDING THE POSSIBLE FRAGMENT. AS OF MAY 8, THE PATIENT WAS STABLE WITHOUT PAIN. THE DEVICE WAS THE FIRST USE WHEN THE ISSUE OCCURRED. THE SALES REP TOOK AN ENLARGED IMAGE OF THE CANNULA¿S INNER CYLINDER WITH HIS SMARTPHONE AND NOTICED A TINY CHIPPED AREA ON THE CYLINDER¿S TIP. FURTHER MEDICAL INTERVENTION IS NOT PLANNED. NO SURGICAL DELAY REPORTED. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 10077162 ↗