Versaport Plus 177995PRecalls & reported problems
Covidien LP · Trocar Sleeve · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884521094502), received between May 25, 2021 and May 25, 2021 — classified as 1 injury.
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
- Detachment of Device or Device Component1
- Packaging Problem1
Patient problems
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 25, 2021Break; Detachment of Device or Device Component; Packaging Problem; Break; Detachment of Device or Device Component; Packaging Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC REMOVAL OF ECTOPIC PREGNANCY, ON ACCESS, THE 10MM TROCAR SLEEVE BROKE OFF AND WAS FOUND IN THE PATIENT'S ABDOMINAL CAVITY AND WAS RETRIEVED BY USING A GRASPER. THE SEARCH FOR THE BROKEN PART FROM THE TIP OF THE TROCAR TOOK LONGER THAN THE PROCEDURE. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE. ANOTHER SLEEVE WAS OPENED TO RESOLVE THE ISSUE.
Patient problems: Unspecified Tissue Injury
MAUDE report 11880928 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.