VersaOne ONB5STF2CRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521657656), received between Jan 30, 2018 and May 20, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC SLEEVE, THE STOPCOCK AND CANNULA BROKE AND THE WHITE TOP PART PEEL OFF. THE PORT WAS REMOVED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19356406 ↗
• MalfunctionApr 26, 2024Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE OBTURATOR WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197243 ↗
• MalfunctionOct 13, 2022Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC CHOLECYSTECTOMY, DURING TROCAR INSERTION, THE OBTURATOR BROKE. THE OBTURATOR CANNOT BE WITHDRAWN FROM CANNULA AFTER INSERTION. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE SURGERY WAS INTERRUPTED.

  Patient problems: Insufficient Information

  MAUDE report 15597054 ↗
• MalfunctionMay 20, 2022Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING INCISION ON THE ABDOMEN WITH TROCAR TO REMOVE THE MANDRIN, SURGEON FAILED TO REMOVE THE STYLET FROM THE TROCAR. SURGEON USED ANOTHER TROCAR TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14464275 ↗
• MalfunctionSep 22, 2020Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING PLACEMENT OF TROCAR ON A LAPAROSCOPIC CHOLECYSTECTOMY, THE TROCAR DILATOR WENT STRICTLY TO REMOVE AND IT GOT STUCK IN THE TROCAR. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10565719 ↗
• MalfunctionJul 20, 2018Material Fragmentation; Unsealed Device Packaging; Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE DEVICE HAD A DAMAGED SEAL. WHEN INSERTING THE DEVICE INTO SLEEVE, A SMALL PIECE OF PLASTIC BLUE VALVE SHAVED OFF AND HAD TO BE RETRIEVED FROM PATIENT. THEY OPENED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7706415 ↗
• MalfunctionJan 30, 2018Break; Difficult to Insert; Break; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE WAS STICKING INSIDE THE TROCAR AND EXTREMELY DI FFICULT TO PUSH. THE DEVICE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7229279 ↗

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-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-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-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