VersaOne NONB12STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 10884521546882), received between Dec 9, 2016 and Aug 11, 2026 — classified as 4 injuries, 125 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (61 reports).

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 129 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Break

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

  MAUDE report 50201363 ↗
• MalfunctionMar 3, 2026Leak/Splash; Decrease in Pressure

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, THE DEVICE EXHIBITED MATERIAL LEAKAGE THAT COMPROMISED PNEUMOPERITONEUM. IT WAS NOTED THAT THERE WAS A RAPID LOSS OF PNEUMOPERITONEUM NECESSITATING IMMEDIATE PRODUCT REPLACEMENT TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497342 ↗
• MalfunctionFeb 18, 2026Leak/Splash; Decrease in Pressure

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TROCAR LEAKED WHICH RESULTED IN A RAPID LOSS OF PNEUMOPERITONEUM. TO RESOLVE THE ISSUE, A NEW DEVICE OF THE SAME TYPE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379826 ↗
• MalfunctionDec 22, 2025Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  IT WAS REPORTED THAT DURING A VENTRAL LAPAROSCOPIC (VLP) RECTOSIGMOIDECTOMY, HEAVY LEAKING FROM THE TROCAR OCCURRED AT THE BEGINNING OF SURGERY WHEN THE TROCAR WAS INSERTED. THIS RESULTED IN A RAPID LOSS OF PNEUMOPERITONEUM. THE TROCAR WAS REPLACED TO ALLOW THE PR OCEDURE TO CONTINUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865659 ↗
• MalfunctionDec 17, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TROCAR WAS LEAKING GAS, AND THE SEAL ON THE DEVICE WAS DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 23826413 ↗
• MalfunctionDec 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, AIR OR GAS LEAKED FROM THE SEAL OF MULTIPLE TROCARS. THE LEAKING SOUND COULD BE HEARD FROM ONE OF THE TROCARS AND ONE TROCAR HAD A LOOSE SEAL. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 23730384 ↗
• MalfunctionDec 5, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE TROCAR EXHIBITED A DEFECT IN THE CARBON DIOXIDE (CO2) CONNECTOR, RESULTING IN A CO2 LEAK FROM THE TROCAR. THE CANNULA MEMBRANE WAS FOUND TO BE PERFORATED, WHICH CONTRIBUTED TO THE CO2 LEAK. UPON TESTING, THE CANNULA MEMBRANE PERFORATION WAS VERIFIED. THE TROCAR WAS REPLACED WITH A COMPLETE NEW UNIT TO RESOLVE THE ISSUE AND ALLOW THE PROCEDURE TO CONTINUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23726078 ↗
• MalfunctionNov 5, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTROPLASTY BYPASS, THE TROCAR WAS LEAKING PROFUSELY AT THE BEGINNING OF THE PROCEDURE AND THE SEAL WAS DAMAGED. IT WAS NECESSARY TO OPEN ANOTHER TROCAR TO COMPLETE THE SURGERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23473996 ↗
• MalfunctionNov 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHILE THE DEVICE WAS BEING PLACED IN PATIENT, THE SURGEON REALIZED AN AIR OR GAS LEAKED FROM THE SEAL DUE TO A BROKEN VALVE SEAL. THE NURSE OPENED ANOTHER NEW TROCAR TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 23468845 ↗
• MalfunctionOct 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GALLBLADDER SURGERY, TWO TROCARS WERE FOUND TO HAVE A DAMAGED SEAL AND THE VALVE WAS NOT TIGHT, RESULTING IN GAS LEAKAGE DURING THE INSUFFLATION STEP OF THE PROCEDURE. THE ISSUE WAS RESOLVED BY REPLACING THE PRODUCT WITH ANOTHER MANUFACTURER'S DEVICE, AND THE CASE WAS COMPLETED WITHOUT ADDITIONAL OPERATIONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23341259 ↗
• MalfunctionOct 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GALLBLADDER SURGERY, TWO TROCARS WERE FOUND TO HAVE A DAMAGED SEAL AND THE VALVE WAS NOT TIGHT, RESULTING IN GAS LEAKAGE DURING THE INSUFFLATION STEP OF THE PROCEDURE. THE ISSUE WAS RESOLVED BY REPLACING THE PRODUCT WITH ANOTHER MANUFACTURER'S DEVICE, AND THE CASE WAS COMPLETED WITHOUT ADDITIONAL OPERATIONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23341161 ↗
• MalfunctionOct 15, 2025Leak/Splash; Detachment of Device or Device Component; Material Split, Cut or Torn; Leak/Splash; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC APPENDECTOMY, THE SEAL OF THE PORT WAS DAMAGED AND DISENGAGED WHICH CAUSED AIR OR GAS TO LEAK FROM THE SEAL. THE CANNULA ALSO DETACHED FROM THE TOP PORTION OF THE PORT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23297557 ↗
• MalfunctionSep 8, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THERE WAS DIFFICULTY PENETRATING AND FAILURE OF THE SEALING MECHANISM WHEN PASSING THE CLIPPER. THE CLAMP WOULD FALL DUE TO THE FORCE USED TO PASS THE CLIPPER THROUGH THE TROCAR, AND THE SEAL WOULD BECOME OBLITERATED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22999479 ↗
• MalfunctionSep 8, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA, AT THE START OF THE PROCEDURE, THE SURGEON NOTICED THAT THE TROCAR WAS CRACKED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993870 ↗
• MalfunctionAug 5, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDICECTOMY, THE TROCAR BROKE AND A MATERIAL FROM THE TROCAR COMPONENT DEVICE FELL INTO THE CAVITY OF THE PATIENT. THE MATERIAL WAS RETRIEVED AND AN X-RAY WAS NOT NECESSARY TO LOCATE OR CONFIRM RETRIEVAL OF THE COMPONENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22717391 ↗
• MalfunctionJun 19, 2025Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTROPLASTY BYPASS, THE SURGEON USED A CLIPPER BUT IT DID NOT FIT IN THE TROCAR. ANOTHER DEVICE FROM OTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294324 ↗
• MalfunctionJun 10, 2025Break; Break

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC CHOLECYSTECTOMY, AT THE START OF THE SURGERY, THE TROCAR WAS BROKEN THE ISSUE WAS RESOLVED BY REPLACING THE TROCAR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175382 ↗
• MalfunctionMay 21, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A VIDEO LAPAROSCOPIC TOTAL SPLENECTOMY, THERE WAS A GAS LEAK FROM THE TROCAR AND THE SEAL WAS DAMAGED. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH ANOTHER IDENTICAL ITEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22058970 ↗
• MalfunctionMay 12, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, WHILE PASSING A FORCEPS THROUGH THE DEVICE, THE EXTERNAL VALVE WAS LOOSE AND TORN. IT THEN FELL INTO THE ABDOMINAL CAVITY OF THE PATIENT AND WAS REMOVED WITHOUT FURTHER DAMAGE. THE PRODUCT WAS REPLACED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006886 ↗
• MalfunctionMay 5, 2025Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC GASTROPLASTY BYPASS, THE TROCAR LEAKED AFTER THE ENDOSCOPIC STAPLER WAS PASSED. IT WAS IMPOSSIBLE TO CONTINUE USING THE TROCAR, BECAUSE WHEN USING THE 5MM FORCEPS, THE PNEUMOPERITONEUM WAS LOWERED AND LOST RAPIDLY. ANOTHER TYPE OF TROCAR WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21958209 ↗
• MalfunctionApr 30, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IN A VIDEO LAPAROSCOPIC GASTROPLASTY BYPASS WAS, WHEN TRYING TO PASS THE FORCEPS THROUGH THE TROCAR, THE RUBBER SEAL TORE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21939869 ↗
• MalfunctionApr 30, 2025Decrease in Pressure; Detachment of Device or Device Component; Decrease in Pressure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY, THERE WAS A LOSS OF PNEUMOPERITONEUM DUE TO A LOOSE EXTERNAL SEAL WHILE USING THE TROCAR. THE ISSUE WAS IDENTIFIED WHEN PASSING THE ENDOSTAPLER, AND AIR OR GAS LEAKED FROM THE SEAL. THE PRODUCT WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934497 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE MATERIAL BROKE, NECESSITATING THE USE OF ANOTHER TROCAR TO CONTINUE THE SURGERY, WHICH RESULTED IN A DELAY OF THE ENTIRE SURGICAL PROCESS.

  Patient problems: Insufficient Information

  MAUDE report 21886338 ↗
• MalfunctionApr 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE RUBBER OF THE TROCAR CAME OFF.

  Patient problems: Insufficient Information

  MAUDE report 21884748 ↗
• MalfunctionApr 21, 2025Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE RUBBER ON THE TROCAR CAME LOOSE WHEN THE CLIPPER PASSED THROUGH, AND AIR OR GAS LEAKED FROM THE SEAL. THE PRODUCT WAS REPLACED BY ANOTHER ONE TO RESOLVE THE ISSUE AND COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21874739 ↗