Versaport ONB5LGFRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521134218), received between Mar 28, 2019 and Aug 30, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionAug 30, 2022Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE OBTURATOR WAS STUCK INSIDE CANNULA, THE CLIPS WOULD NOT RELEASE ONCE IT WAS INSIDE THE ABDOMEN, AND DID NOT WORK. THE TROCAR WAS EVENTUALLY RELEASED WITH SOME FORCE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324493 ↗
• MalfunctionNov 13, 2020Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING INSERTION OF TROCAR IN A ROBOTIC SLEEVE GASTRECTOMY, THE OBTURATOR OF THE DEVICE SEPARATED FROM THE UPPER HUB WHEN INSERTING THE TROCAR. THE SURGEON USED ANOTHER TROCAR TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10835729 ↗
• MalfunctionMar 28, 2019Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHEN THEY OPENED THE PACKAGE, THE UPPER PART OF OBTURATOR SHAFT WAS ALREADY BENT. THEY CHANGED TO A DIFFERENT PRODUCT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8461034 ↗

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-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
• 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-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-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-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-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,