VersaOne ONB5STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 143 adverse event reports that list this exact device (DI 10884521657632), received between May 9, 2017 and Aug 18, 2026 — classified as 1 death, 9 injuries, 133 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (44 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 25 most recent of 143 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50312249 ↗
• MalfunctionMar 2, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE TIP OF THE TROCAR COMPLETELY DETACHED DURING INSERTION AND CAUSED A TEAR IN THE ILIAC VEIN.

  Patient problems: Tissue Breakdown

  MAUDE report 24491303 ↗
• MalfunctionFeb 20, 2026Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPY, THE CLEAR TIP OF THE TROCAR BROKE OFF DURING INSERTION WHICH LED TO VASCULAR INJURY.

  Patient problems: Tissue Breakdown

  MAUDE report 24404139 ↗
• MalfunctionJan 21, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PLACEMENT OF THE UMBILICAL PORT, THE INTERNAL SEAL ON THE 5MM TROCAR WITH FIXATION CANNULA ACCIDENTALLY WENT INTO THE PATIENT¿S ABDOMEN. THE SEAL WAS PROMPTLY REMOVED FROM THE ABDOMEN, AND THE ENTIRE PORT WAS REMOVED FROM THE STERILE FIELD. ALL PIECES OF THE DEVICE WERE ACCOUNTED FOR AND SUBSEQUENTLY BAGGED AND HANDED OVER TO THE CHARGE NURSE.

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

  MAUDE report 24130702 ↗
• MalfunctionJul 24, 2025Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREADED TROCAR HAD A NON-VISIBLE INTERNAL DEFECT THAT PREVENTED THE INSTRUMENT FROM SLIDING EASILY THROUGH THE CANNULA. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 22591445 ↗
• MalfunctionJun 9, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE TROCAR BROKE UPON FIRST ENTRY/INTRODUCTION WITH THE CAMERA INSERTED INTO THE OPTICAL PORTION OF THE TROCAR. THE BROKEN PIECE FELL INTO THE BOTTOM OF THE OPTICAL PORTION OF THE TROCAR AND DID NOT ENTER THE PATIENT CAVITY. THE PROCEDURE WAS COMPLETED AFTER THE TROCAR WAS REMOVED AND REPLACED WITH ANOTHER OPTICAL OBTURATOR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22172035 ↗
• MalfunctionMar 21, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC GASTRIC BYPASS, AIR OR GAS LEAKED FROM THE SEAL. THERE WAS A SLIGHT TEAR IN THE SEAL. WHEN A GRASPER WAS PUT DOWN THE PORT, THE SEAL RIPPED AND THE TROCAR STARTED LEAKING AT THE END OF THE PROCEDURE. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. THE TROCAR STARTED LEAKING AT THE END OF THE PROCEDURE SO THE SURGEON FINISHED THE CASE WITH A SLIGHT PNEUMO LEAK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661383 ↗
• InjuryFeb 10, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC ADNEXECTOMY, THE SEAL OF TWO 5 MM TROCARS AND ONE 12 MM TROCAR WERE BROKEN. WHEN A ROUTINE CT (COMPUTED TOMOGRAPHY) SCAN WAS PERFORMED AFTER THE SURGERY, IT WAS REVEALED THAT THERE WERE METAL FRAGMENTS INSIDE THE BODY. THE FRAGMENTS HAVE A ROUND SHAPE OF ABOUT 3 MM. THE ORIGIN OF THE METAL FRAGMENTS COULD NOT BE DETERMINED. A SEALING DEVICE AND A SPECIMEN BAG WERE ALSO USED ALONG WITH THE THREE TROCARS. THE FRAGMENTS HAVE NOT BEEN COLLECTED. IT IS UNDECIDED WHETHER OR NOT TO COLLECT THE FRAGMENTS.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 21346096 ↗
• InjuryFeb 10, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC ADNEXECTOMY, THE SEAL OF TWO 5MM TROCARS AND ONE 12MM TROCAR WERE BROKEN. WHEN A ROUTINE CT (COMPUTED TOMOGRAPHY) SCAN WAS PERFORMED AFTER THE SURGERY, IT WAS REVEALED THAT THERE WERE METAL FRAGMENTS INSIDE THE BODY. THE FRAGMENTS HAVE A ROUND SHAPE OF ABOUT 3MM. THE ORIGIN OF THE METAL FRAGMENTS COULD NOT BE DETERMINED. A SEALING DEVICE AND A SPECIMEN BAG WERE ALSO USED ALONG WITH THE THREE TROCARS. THE FRAGMENTS HAVE NOT BEEN COLLECTED. IT IS UNDECIDED WHETHER OR NOT TO COLLECT THE FRAGMENTS.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 21345611 ↗
• MalfunctionOct 1, 2024Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLON RESECTION, THE INNER TUBE COULD NOT BE REMOVED AFTER INSERTING THE TROCAR AT THE BEGINNING OF THE PROCEDURE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343455 ↗
• MalfunctionMay 13, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, THE SEAL WAS DAMAGED. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305060 ↗
• MalfunctionFeb 7, 2024Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN THE DEVICE WAS INSERTED INTO THE CANNULA, IT GOT STUCK. IT WAS NOTICED THAT THE SEAL WAS DISENGAGED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18663211 ↗
• MalfunctionJan 12, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, AFTER BOTH TROCARS WERE PASSED THROUGH THE PERITONEUM, IT WAS NOTICED THAT THE TIP OF BOTH TROCAR WAS BROKEN. IT WAS ALSO REPORTED THAT THE TIP OF BOTH DEVICE FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18508059 ↗
• MalfunctionJan 12, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, AFTER BOTH TROCARS WERE PASSED THROUGH THE PERITONEUM, IT WAS NOTICED THAT THE TIP OF BOTH TROCAR WAS BROKEN. IT WAS ALSO REPORTED THAT THE TIP OF BOTH DEVICE FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18507613 ↗
• MalfunctionDec 15, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC APPENDECTOMY, UPON OBSERVING THE TROCAR AFTER BEING REMOVED FROM THE PACKAGING AT THE B EGINNING OF THE PROCEDURE, IT WAS NOTICED THAT THE TIP WAS BENT. THE CANNULA ALSO BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340711 ↗
• MalfunctionDec 11, 2023Break; Difficult to Remove; Break; Difficult to Remove

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE OBTURATOR WOULD NOT DISCONNECT FROM THE CANNULA. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18302497 ↗
• MalfunctionSep 20, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING ROBOTIC LAPAROSCOPIC HERNIOPLASTY VENTRAL PROCEDURE, WHEN THE DOCTOR PLACES THE TROCAR, THERE WAS A GAS LEAK AND THE SEAL WAS DAMAGED. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17780435 ↗
• MalfunctionJul 18, 2023Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE OBTURATOR/TROCAR BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17345707 ↗
• MalfunctionJul 5, 2023Break; Break

  ACCORDING TO THE REPORTER. PREOPERATIVELY, THE TROCAR WAS PASSED TO THE SURGICAL TABLE AND IDENTIFIED AS HAVING DAMAGE TO IT'S TIP. IT WAS PASTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17261666 ↗
• MalfunctionApr 24, 2023Break; Break

  ACCORDING TO THE REPORTER, AFTER A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE TROCAR WAS REMOVED, THE CANNULA BROKE. NOTHING WAS DONE IN PARTICULAR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16797889 ↗
• MalfunctionMar 21, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, FOR THE ENTIRE PROCEDURE, THE 5MM PORT HAD ONLY ONE FORCEPS IN IT BUT THE DEVICE LEAKED GAS. THE SEAL WAS DAMAGED. THE DEVICE WAS CONTINUED TO BE USED AS IT WAS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16585530 ↗
• MalfunctionFeb 1, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, THE DEVICE WAS STUCK INSIDE THE TROCAR. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16280132 ↗
• MalfunctionJan 6, 2023Device Contamination with Chemical or Other Material; Material Split, Cut or Torn; Device Contamination with Chemical or Other Material; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SEAL WAS DAMAGED AND FOREIGN OBJECT WAS OBSERVED IN THE STERILIZED BAG. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118837 ↗
• MalfunctionNov 28, 2022Precipitate in Device or Device Ingredient; Material Split, Cut or Torn; Precipitate in Device or Device Ingredient; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE DEVICE WAS OBSERVED VISUALLY AND WAS TOUCHED, EXCESSIVE AMOUNT OF LUBRICANT WAS FOUND ON THE ENTIRE TROCAR HOUSING PART, SO USE WAS DISCONTINUED JUST TO BE SAFE. THE SEAL OF THE DEVICE WAS DAMAGED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15870240 ↗
• MalfunctionOct 1, 2022Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN INSERTION OF THE PORTS AT THE START OF THE PROCEDURE. PRODUCT WAS INSERTED INTO THE PATIENT'S ABDOMINAL WALL AND WAS UNABLE TO REMOVE THE OBTURATOR AFTER INSERTION. OBTURATOR WAS NOT BROKEN BUT STUCK. ANOTHER NEW TROCAR PORT WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15525239 ↗

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-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-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,