Skip to content

Step S101005Recalls & reported problems

Covidien LP · Dilator and Cannula with Radially Expandable Sleeve · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884521090733), received between Sep 26, 2018 and Sep 26, 2018 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1
  • Packaging Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 26, 2018Break; Packaging Problem; Break; Packaging Problem

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, AT THE BEGINNING OF THE CASE, AS SOON AS SCOPE ENTERED TROCAR, THE OBTURA TOR/TROCAR BROKE. THE COATING INSIDE THE CANNULA FLAKED OFF. THEY GRABBED A NEW TROCAR TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7911272 ↗

Other Laparoscope, general & plastic surgery devices

All Laparoscope, general & plastic surgery devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.