NA 012421Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010073655), received between Oct 1, 2020 and Jan 20, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 20, 2021Break; Break

  IT WAS REPORTED THAT DURING ARTHROSCOPY SURGERY, THEIR S&N CANNULA TROCARS DID NOT SEEM TO FIT INSIDE THE CANNULA. THEY FELT AS IF THE CANNULA WAS NOT WIDE ENOUGH FOR THE TROCAR AND PIECES BROKE OFF IN THE JOINT WHEN INSERTING THE TROCAR IN THE CANNULA. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH NO DELAY OR OTHER COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11202616 ↗
• InjuryDec 17, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE S&N CANNULA TROCAR DID NOT SEEM TO FIT INSIDE THE CANNULA. THEY FELT AS IF THE CANNULA WAS NOT WIDE ENOUGH FOR THE TROCAR AND PIECES BROKE OFF IN THE JOINT WHEN INSERTING THE TROCAR IN THE CANNULA. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH NO DELAY OR OTHER COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11029667 ↗
• InjuryOct 1, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE WHITE OUTFLOW CAP ON THE SIDE OF THE CANNULA KEEPS POPPING OFF FROM THE PRESSURE OF THE FLUID IN THE JOINT. EVEN WHEN YOU FULLY TIGHTEN IT DOWN IT SLIPS/POPS OFF. YOU CANNOT OVER TIGHTEN THE CAP EITHER OR ELSE IT BECOMES LOOSE AS IF THE THREADS ARE STRIPPED. THIS IS A RECURRENT MALFUNCTION. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE WITH A DELAY SHORTER THAN 30 MINUTES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10613615 ↗