Versaport ONB5STF2CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521134249), received between Jan 3, 2023 and Jan 3, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K112349); they may or may not involve this specific model.

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

• MalfunctionJan 3, 2023Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTOSIGMOID RESECTION, AS SOON AS A CERTAIN FORCE WAS BUILT UP IN THE TROCAR BY LOWERING THE INSTRUMENT AGAINST AN OBESE ABDOMINAL WALL, THE RUBBER LEAKS AND THE CARBON DIOXIDE ESCAPES FROM THE TROCAR. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086950 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112349. One submission often covers many models, so check the product and lot details in each record.

• Z-1467-2013 · May 6, 2013 · Terminated
  Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5LGF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gyneco
• Z-1472-2013 · May 6, 2013 · Terminated
  Versaport Bladeless Optical Fixation Cannula - 5mm Product Code: ONBFCA5ST The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general,
• Z-1469-2013 · May 6, 2013 · Terminated
  Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ONB5STF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic,
• Z-1471-2013 · May 6, 2013 · Terminated
  Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA5SH The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, ge
• Z-1468-2013 · May 6, 2013 · Terminated
  Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product Code: ONB5SHF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynec
• Z-1470-2013 · May 6, 2013 · Terminated
  Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gyne