VersaOne ONB5STBRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10884521809017), received between Aug 13, 2024 and Apr 1, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (9 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A TOTAL HYSTERECTOMY, THE BALLOON TROCAR SEAL WAS DAMAGED AND WAS REPEATEDLY DEFLATING DURING THE PROCEDURE. THE CASE WAS ABLE TO BE COMPLETED WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750722 ↗
• MalfunctionMar 31, 2026Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BALLOON TROCAR SEAL WAS DAMAGED AND WAS REPEATEDLY DEFLATING DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750518 ↗
• MalfunctionNov 19, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE BALLOON TROCAR WAS INSERTED INTO THE ABDOMEN OF THE PATIENT, AFTER WHICH THE BALLOON WAS INFLATED BUT IMMEDIATELY DEFLATED AND COULD NOT BE REINFLATED. THE TROCAR POPPED OUT ONCE TENSION WAS APPLIED. A NEW TROCAR WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23592116 ↗
• MalfunctionSep 9, 2025Break; Break

  IT WAS REPORTED THAT DURING A LEFT DONOR NEPHRECTOMY, THE BALLOON WOULD NOT STAY INFLATED, AND THE BALLOON SEAL WAS BROKEN. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006609 ↗
• MalfunctionSep 4, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC SLEEVE TO ROUX EN Y CONVERSION, DURING PLACEMENT OF THE TROCAR INTO THE ABDOMEN, THE BALLOON WAS INFLATED AND SOON AFTER THE BALLOON DEFLATED AND WOULD NOT HOLD AIR AS IF IT ALMOST HAD HOLE IN IT. THE BALLOON TROCAR WAS LEFT DEFLATED AND ANOTHER REGULAR 5 MM TROCAR WAS USED TO 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 22967319 ↗
• MalfunctionJul 14, 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

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SALPINGECTOMY, A PLASTIC COMPONENT FELL INTO THE ABDOMINAL CAVITY WHILE GAINING ACCESS WITH THE TROCAR. THE ACCESS PORT DEVICE EXHIBITED A DAMAGED SEAL AND GAS LEAKED FROM THE SEAL. THE PLASTIC MATERIAL THAT DROPPED INTO THE ABDOMEN WAS REMOVED FROM THE PATIENT USING A GRASPER, AND THE PROCEDURE RESUMED AS NORMAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22502507 ↗
• MalfunctionApr 21, 2025Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH), CO2 LEAKAGE OCCURRED INTO THE PATIENT'S RIGHT LABIA DUE TO A DEFLATED BALLOON ON A BALLOON TIP TROCAR. THIS RESULTED IN TISSUE DAMAGE AND SIGNIFICANT POST-OPERATIVE PAIN. THE CO2 TRAVELED THROUGH THE SUBCUTANEOUS LAYER, INFLATING THE PATIENT'S LABIA. THE ISSUE WAS DISCOVERED AT THE END OF THE PROCEDURE WHEN REMOVING THE BALLOON TIP TROCAR. THE SURGEON STOPPED USING THE BALLOON-TIPPED TROCAR TO RESOLVE THE ISSUE AND COMPLETE THE CASE.

  Patient problems: Pain; Tissue Breakdown

  MAUDE report 21874515 ↗
• MalfunctionMar 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY, AT THE BEGINNING OF THE PROCEDURE, THE SEAL AT THE END OF THE BALLOON WAS BROKEN AND IT DID NOT INFLATE. A NEW PORT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21679741 ↗
• MalfunctionMar 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, THE BALLOON TROCAR WAS USED AS THE SECOND PORT. THE BALLOON DEFLATED OR POPPED WITHIN 5 MINUTES OF BEING INFLATED. THE SURGEON ATTEMPTED TO REINFLATE THE BALLOON, BUT IT WENT FLAT AGAIN. ANOTHER BALLOON TROCAR WAS USED AND IT DEFLATED. THE ISSUE WAS RESOLVED BY OPENING A NEW BALLOON TROCAR AND REPLACING THE PORT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21615791 ↗
• MalfunctionFeb 3, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC NON-CANCER GYNECOLOGICAL PROCEDURE, THERE WAS A PRODUCT FAILURE INVOLVING THE BALLOON TROCAR. THE BALLOON WOULD NOT INFLATE. TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE, THE TROCAR WAS REPLACED WITH ANOTHER 5MM TROCAR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21291149 ↗
• MalfunctionJan 24, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE FOR A GIANT HIATAL HERNIA, A BALLOON 5MM STANDARD EXPERIENCED ISSUES. THE BALLOON BURST WHILE AIR WAS BEING INSERTED AFTER ITS PLACEMENT, AND THERE WAS A DAMAGED SEAL. THE DEVICE WAS BEING APPLIED DURING THE STEP OF BLOWING UP THE BALLOON. TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE, ANOTHER DEVICE WAS OPENED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229010 ↗
• MalfunctionJan 13, 2025Inflation Problem; Human-Device Interface Problem; Inflation Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE BALLOON TIP TROCAR HAD DEFLATED AT THE END OF THE PROCEDURE. IT WAS NOTED THAT THE TROCAR HAD ISSUES INSUFFLATING THE ABDOMINAL CAVITY. AS A RESOLUTION, THE INSUFFLATION TUBE WAS TAKEN FROM THE TROCAR USING THE RETRACTABLE L HOOK AND PLACED ON THE SCOPE TROCAR TO CONTINUE THE INFLATION OF THE ABDOMINAL CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143375 ↗
• MalfunctionNov 27, 2024Break; Gas/Air Leak; Break; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE, AT THE END OF THE PROCEDURE, WHILE TAKING OUT THE THREE DEVICES, THE BALLOON DEFLATED. ADDITIONALLY, THE CANNULA BROKE. NO RESOLUTION WAS NEEDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798828 ↗
• MalfunctionNov 27, 2024Break; Gas/Air Leak; Break; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE, AT THE END OF THE PROCEDURE, WHILE TAKING OUT THE THREE DEVICES, THE BALLOON DEFLATED. ADDITIONALLY, THE CANNULA BROKE. NO RESOLUTION WAS NEEDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798812 ↗
• MalfunctionNov 27, 2024Break; Gas/Air Leak; Break; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE, AT THE END OF THE PROCEDURE, WHILE TAKING OUT THE THREE DEVICES, THE BALLOON DEFLATED. NO RESOLUTION WAS NEEDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798734 ↗
• MalfunctionNov 8, 2024Break; Gas/Air Leak; Break; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE BALLOON DEFLATED BEFORE THE CASE WAS OVER. IT WAS ALSO NOTED THAT THE OBTURATOR/ TROCAR BROKE. A COMPETITOR'S TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20645722 ↗
• MalfunctionOct 2, 2024Break; Gas/Air Leak; Break; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SACROCOLPOPEXY, SHORTLY AFTER INSERTING THE BALLOON TIP TROCAR, THE BALLOON DEFLATED. A NEW BALLOON TIP TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20351529 ↗
• MalfunctionAug 28, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  ACCORDING TO THE REPORTER, DURING THE TOTAL LAPAROSCOPIC HYSTERECTOMY, THE  THREE DEFECTED UNITS WERE OBSERVED TO LEAK AT THE DISTAL END OF THE CANNULA WHEN TESTED UNDER A SALINE SOLUTION. SMALL BUBBLES WERE OBSERVED TO BE COMING FROM ONE SPOT ON THE INTERFACE OF THE BALLOON TO THE CANNULA. ALL THE BALLOON TIP TROCARS WERE INFLATED FOR A FEW MINUTES ON THE MAYO STAND TO OBSERVE ANY LEAKS IN THE BALLOON. BALLOONS WERE THEN DEFLATED AND PLACED INTO THE INCISION. THE FIRST BALLOON TIP DEFLATED IMMEDIATELY AFTER INSERTION THROUGH THE INCISION. THE SECOND BALLOON TIP DEFLATED WITHIN A FEW MINUTES ( ESTIMATED 2 - 3 MINS) AFTER INSERTION THROUGH THE INCISION. THE THIRD BALLOON DEFLATED WITHIN AN ESTIMATED 20 MINS AFTER INSERTION THROUGH THE INCISION. SURGEON ALSO NOTICED THAT THE CO2 HAD ENTERED THRU THE TISSUE LAYERS CAUSING THE RIGHT INGUINAL SIDE TO INFLATE SLIGHTLY. TO RESOLVE THE ISSUE, ANOTHER BALLOON WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20090077 ↗
• MalfunctionAug 28, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  ACCORDING TO THE REPORTER, DURING THE TOTAL LAPAROSCOPIC HYSTERECTOMY, THE  THREE DEFECTED UNITS WERE OBSERVED TO LEAK AT THE DISTAL END OF THE CANNULA WHEN TESTED UNDER A SALINE SOLUTION. SMALL BUBBLES WERE OBSERVED TO BE COMING FROM ONE SPOT ON THE INTERFACE OF THE BALLOON TO THE CANNULA. ALL THE BALLOON TIP TROCARS WERE INFLATED FOR A FEW MINUTES ON THE MAYO STAND TO OBSERVE ANY LEAKS IN THE BALLOON. BALLOONS WERE THEN DEFLATED AND PLACED INTO THE INCISION. THE FIRST BALLOON TIP DEFLATED IMMEDIATELY AFTER INSERTION THROUGH THE INCISION. THE SECOND BALLOON TIP DEFLATED WITHIN A FEW MINUTES ( ESTIMATED 2 - 3 MINS) AFTER INSERTION THROUGH THE INCISION. THE THIRD BALLOON DEFLATED WITHIN AN ESTIMATED 20 MINS AFTER INSERTION THROUGH THE INCISION. SURGEON ALSO NOTICED THAT THE CO2 HAD ENTERED THRU THE TISSUE LAYERS CAUSING THE RIGHT INGUINAL SIDE TO INFLATE SLIGHTLY. TO RESOLVE THE ISSUE, ANOTHER BALLOON WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20089993 ↗
• MalfunctionAug 28, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  ACCORDING TO THE REPORTER, DURING THE TOTAL LAPAROSCOPIC HYSTERECTOMY, THE  THREE DEFECTED UNITS WERE OBSERVED TO LEAK AT THE DISTAL END OF THE CANNULA WHEN TESTED UNDER A SALINE SOLUTION. SMALL BUBBLES WERE OBSERVED TO BE COMING FROM ONE SPOT ON THE INTERFACE OF THE BALLOON TO THE CANNULA. ALL THE BALLOON TIP TROCARS WERE INFLATED FOR A FEW MINUTES ON THE MAYO STAND TO OBSERVE ANY LEAKS IN THE BALLOON. BALLOONS WERE THEN DEFLATED AND PLACED INTO THE INCISION. THE FIRST BALLOON TIP DEFLATED IMMEDIATELY AFTER INSERTION THROUGH THE INCISION. THE SECOND BALLOON TIP DEFLATED WITHIN A FEW MINUTES ( ESTIMATED 2 - 3 MINS) AFTER INSERTION THROUGH THE INCISION. THE THIRD BALLOON DEFLATED WITHIN AN ESTIMATED 20 MINS AFTER INSERTION THROUGH THE INCISION. SURGEON ALSO NOTICED THAT THE CO2 HAD ENTERED THRU THE TISSUE LAYERS CAUSING THE RIGHT INGUINAL SIDE TO INFLATE SLIGHTLY. TO RESOLVE THE ISSUE, ANOTHER BALLOON WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20089806 ↗
• MalfunctionAug 13, 2024Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC POSSIBLE OPEN PARTIAL COLECTOMY, WHEN THE BALLOON TROCAR WAS OPENED AND PASSED OFF TO P HYSICIAN DURING ACCESS, THE PHYSICIAN INSERTED THE TROCAR AND INFLATED THE BALLOON WITH 5ML OF AIR FROM THE SYRINGE. AIR IMMEDIATELY DID NOT INFLATE. THE PHYSICIAN TRIED 5ML MORE OF AIR, BUT THE SAME ISSUE OCCURRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19978658 ↗