VersaOne UNVCA5STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 30884521215423), received between Mar 31, 2017 and Aug 6, 2026 — classified as 4 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (23 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 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Leak/Splash; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50151353 ↗
• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, AT THE BEGINNING OF THE PROCEDURE, THE CANNULA WAS FOUND TO HAVE A RUPTURED MEMBRANE. THE DEVICE WAS URGENTLY REPLACED BY ANOTHER PRODUCT TO CONTINUE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284532 ↗
• MalfunctionOct 27, 2025Contamination

  CRUMBLY SUBSTANCE INSIDE PACKAGING. PATIENT NOT AFFECTED, CAUGHT BEFORE USE ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389933 ↗
• MalfunctionMay 26, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE UNVCA5STF UNIVERSAL 5MM STD FIX CANNULA WAS PULLED IN PREPARATION FOR A CASE BUT WAS NOT USED BECAUSE THE CANNULA WAS SMASHED AND BENT. ANOTHER CANNULA WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22083697 ↗
• MalfunctionJan 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC FUNDOPLICATION PROCEDURE, A SEAL WAS DAMAGED ON THE CANNULA AT THE BEGINNING OF THE SURGERY. THE TECHNICIAN PROVIDED ANOTHER CANNULA TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103250 ↗
• MalfunctionDec 6, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC SLEEVE, AT THE START OF THE SURGERY, THE CARBON DIOXIDE (CO2) BEGAN TO LEAK. WHEN THE DEVICE WAS OPENED, THE LUER-LOCK VALVE WAS TAPPED. THE DEVICE WAS REPLACED WITH NEW 5MM CANNULA TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20865689 ↗
• MalfunctionSep 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC SLEEVE, THE SEAL OF THE THREE DEVICES DISENGAGED. A NEW DEVICE OF THE SAME KIND WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20249923 ↗
• MalfunctionJun 28, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC DIAGNOSIS, WHEN ENTERING THE FORCEPS AT THE BEGINNING OF THE SURGERY TO MAKE THE DI AGNOSIS, THE TROCAR WAS PLACED ON THE ABDOMINAL WALL, THE SEAL DAMAGED AND WAS LEAKING. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19635360 ↗
• MalfunctionMay 17, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC GASTRIC BYPASS, WHEN INSERTING THE TROCARS THROUGH THE ABDOMINAL WALL, THE SEALS OF THREE TROCARS WERE BROKEN. CARBON DIOXIDE (CO2) LEAKED. ALL THREE TROCARS WERE REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19343688 ↗
• MalfunctionMar 19, 2024

  PERFORMING LAPAROSCOPIC HYSTERECTOMY WITH INSUFFLATION AND PRESSURE COULD NOT BE MAINTAINED. STRYKER REPS WERE CALLED FOR TROUBLESHOOTING. PROBLEM DID NOT RESOLVE. INSUFFLATION TUBING WAS REPLACED AND PROBLEM WITH MAINTAINING PRESSURE PERSISTED. THE STRYKER REPS SWAPPED OUT INSUFFLATION UNIT. TROCAR BEING USED WAS THE SUSPECTED ISSUE. TROCAR REMOVED FROM THE FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18928954 ↗
• MalfunctionFeb 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NEPHRECTOMY, WHEN INSERTING A NEEDLE, THE SEAL OF THE CANNULA RUPTURED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18771073 ↗
• MalfunctionFeb 22, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN A GRASPER CLAMP WAS INSERTED MIDWAY THROUGH THE PORT, THE MEMBRANE OR SEAL RUPTURED, RESULTING IN GAS LEAKAGE. THE DEVICE WAS REPLACED BY THE SAME LOT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18759616 ↗
• MalfunctionFeb 7, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CANNULA MEMBRANE RUPTURED, PREVENTING IT FROM CREATING A CAVITY AND ALLOWING CARBON DIOXIDE (CO2) TO ESCAPE. TO RESOLVE THE ISSUE, ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18663605 ↗
• MalfunctionFeb 7, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, BEFORE USING ON THE PATIENT, THE MEMBRANE WAS BROKEN AND LEAKING. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18661736 ↗
• MalfunctionJan 30, 2024Leak/Splash; Detachment of Device or Device Component; Insufficient Device Problem Information; Material Split, Cut or Torn; Leak/Splash; Detachment of Device or Device Component; Insufficient Device Problem Information; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC GASTRIC BYPASS, THREE TROCARS HAVE FAILED TO FILTER CO2. THE SEALS WERE DAMAGED AND DISENGAGED. THE DEVICES LEAK AIR OR GAS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18604029 ↗
• MalfunctionDec 18, 2023Detachment 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, DURING LAPAROSCOPIC BYPASS PROCEDURE,  WHEN INTRODUCING A LAPAROSCOPIC FORCEPS, THE 5MM THE MEMBRANE OF THE CANNULA RUPTURED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18351434 ↗
• MalfunctionDec 15, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC BYPASS PROCEDURE, WHEN INTRODUCING A LAPAROSCOPIC FORCEPS, THE TWO 12MM CANNULA MEMBRANE (SEAL) RUPTURED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18338562 ↗
• MalfunctionDec 14, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, AT THE BEGINNING OF THE PROCEDURE, THE CANNULA MEMBRANE RUPTURED AND AN AIR LEAK. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18327598 ↗
• MalfunctionDec 14, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, MONOPOLAR HOOK WAS INTRODUCED THROUGH THE CANNULA AND THE MEMBRANE OF THE CANNULA BY THE PHYSICIAN AT THE START OF THE PROCEDURE, BUT THE CANNULA MEMBRANE RUPTURED AND AIR OR GAS LEAKED FROM THE SEAL. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18327334 ↗
• MalfunctionDec 12, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ENDOMETRIOSIS PROCEDURE, THE MEMBRANE WAS RUPTURED WHEN A CLAMP WAS INSERTED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314608 ↗
• MalfunctionNov 21, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC BYPASS, WHEN THE CLAMP WAS INSERTED, THE CANNULA MEMBRANE RUPTURED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187793 ↗
• MalfunctionNov 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BYPASS PROCEDURE, WHEN A LAPAROSCOPIC CLAMP WAS INSERTED, THE CANULA MEMBRANE (SEAL) RUPTURED. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18174410 ↗
• MalfunctionNov 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BYPASS PROCEDURE, WHEN A CLAMP WAS INSERTED, THE MEMBRANE RUPTURED (SEAL DAMAGED). ANOTHER PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18174362 ↗
• MalfunctionNov 20, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BYPASS, WHEN INTRODUCING THE FORCEPS, THE CANNULA RUPTURED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18171251 ↗
• MalfunctionNov 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC SLEEVE, WHEN A CLAMP WAS INSERTED, THE TROCAR SEAL WAS DAMAGED. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18170445 ↗

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-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
• 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-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-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-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