VersaOne NONB8STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10884521593459), received between Oct 27, 2022 and Sep 16, 2024 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (21 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2024Break; Break

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC ROBOTIC XI SACROCOLPOPEXY, THE TROCAR BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20232565 ↗
• MalfunctionFeb 29, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE AIR WAS LEAKING AND WOULD NOT HOLD INSUFFLATION FOR THE TWO TROCARS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18813501 ↗
• MalfunctionFeb 29, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE AIR WAS LEAKING AND WOULD NOT HOLD INSUFFLATION FOR THE TWO TROCARS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18813476 ↗
• MalfunctionSep 12, 2023Leak/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, DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHILE USING THE TROCAR, THE SEAL WAS DAMAGED AND DISENGAGED. AIR ALSO LEAKED FROM THE SEAL. THE SURGEON CONTINUED USING THE DEVICE AND COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17732141 ↗
• MalfunctionAug 16, 2023Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GYNECOLOGY PROCEDURE, THE SEAL DISENGAGED AND AIR LEAKED. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561287 ↗
• MalfunctionAug 11, 2023Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GYNECOLOGICAL SURGERY, THE SEAL DISENGAGED, THERE WAS AIR OR GAS LEAKED FROM THE SEAL. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 17515789 ↗
• MalfunctionMay 24, 2023Leak/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, DURING A LAPAROSCOPIC PROCEDURE, THE TROCAR STARTED TO LEAK AIR OR GAS. IT WAS ALSO MENTIONED THAT THE SEAL WAS DAMAGED AND DISENGAGED. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991892 ↗
• MalfunctionMay 8, 2023Leak/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, ON A LAPAROSCOPIC HYSTERECTOMY, AT THE BEGINNING OF THE CASE, THE TROCAR WAS WORKING FINE. AS THE CASE WENT ON THE TROCAR STARTED TO LEAK MORE AND MORE. THE SEAL OR THE DEVICE WAS DAMAGED AND DISENGAGED. THE INSUFFLATION TUBE WAS ATTACHED TO THE TROCAR TO KEEP THE PRESSURE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16886443 ↗
• MalfunctionMay 3, 2023Leak/Splash; Detachment of Device or Device Component; Noise, Audible; Material Split, Cut or Torn; Leak/Splash; Detachment of Device or Device Component; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC HYSTERECTOMY, AT THE BEGINNING OF THE CASE, THE DEVICE STARTED LEAKING. THE AIR OR GAS COULD BE HEARD LEAKING FROM THE TROCAR. THE SEAL OR THE DEVICE WAS DAMAGED AND DISENGAGED. ANOTHER DEVICE WAS USED BUT THE DEVICE CONTINUED TO LEAK AND COULD NOT HOLD PRESSURE. THE SURGEON ENDED UP HAVING TO VAGINAL CLOSE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16865717 ↗
• MalfunctionMay 3, 2023Leak/Splash; Detachment of Device or Device Component; Noise, Audible; Material Split, Cut or Torn; Leak/Splash; Detachment of Device or Device Component; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC HYSTERECTOMY, AT THE BEGINNING OF THE CASE, THE DEVICE STARTED LEAKING. THE SEAL OR THE DEVICE WAS DAMAGED AND DISENGAGED. ANOTHER DEVICE WAS USED BUT THE DEVICE CONTINUED TO LEAK AND COULD NOT HOLD PRESSURE. THE SURGEON ENDED UP HAVING TO VAGINAL CLOSE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16865714 ↗
• MalfunctionMay 1, 2023Leak/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, DURING LAPAROSCOPIC SURGERY, THE SEAL WAS DAMAGED AND DISENGAGED. THE AIR LEAKED. THE PNEUMOPERITONEUM CANNOT BE KEPT IN. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16845762 ↗
• MalfunctionApr 18, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY, THE SEAL WAS DAMAGED AND AIR LEAKED. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761966 ↗
• MalfunctionApr 10, 2023Leak/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, DURING A LAPAROSCOPIC PROCEDURE, THE TROCAR HAD AN ISSUE WITH THE SEAL. THE ISSUES WERE A DAMAGED SEAL, A DISENGAGED SEAL AND AIR OR GAS LEAKING FROM THE SEAL. IT WOULD NOT KEEP THE PNEUMOPERITONEUM IN. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16705421 ↗
• MalfunctionApr 7, 2023Leak/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, ON A LAPAROSCOPIC PROCEDURE, THE SEAL OF THE DEVICE WAS DAMAGED. THE SEAL DISENGAGED AND AIR OR GAS LEAKED FROM THE SEAL. THE DEVICE WOULD NOT KEEP THE PNEUMO IN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16701220 ↗
• MalfunctionMar 10, 2023Leak/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, DURING A LAPAROSCOPIC PROCEDURE, THE TWO TROCARS HAD AN ISSUE WITH THE SEAL. THE ISSUES WERE DAMAGED SEAL, DISENGAGED SEAL, AND AIR OR GAS LEAKED FROM THE SEAL. IT WOULD NOT KEEP THE PNEUMO IN. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522809 ↗
• MalfunctionMar 10, 2023Leak/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, DURING A LAPAROSCOPIC PROCEDURE, THE TWO TROCARS HAD AN ISSUE WITH THE SEAL. THE ISSUES WERE DAMAGED SEAL, DISENGAGED SEAL, AND AIR OR GAS LEAKED FROM THE SEAL. IT WOULD NOT KEEP THE PNEUMO IN. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522765 ↗
• MalfunctionFeb 15, 2023Leak/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, DURING A LAPAROSCOPIC PROCEDURE, THE TROCAR HAD AN ISSUE WITH THE SEAL. IT WAS NOTED THAT THERE WAS A DAMAGED SEAL, A DISENGAGED SEAL, AND AIR OR GAS LEAKING FROM THE SEAL. THE DEVICE WOULD NOT KEEP THE PNEUMO IN. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16380121 ↗
• MalfunctionFeb 8, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, WHEN BEING USED ON ABDOMEN, THE SEAL WAS DAMAGED. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16324435 ↗
• MalfunctionJan 25, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE STOPCOCK BROKE AND THE PIECES FELL OFF THE TROCAR AT THE TIP. ANOTHER PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16240473 ↗
• MalfunctionDec 21, 2022Delivered as Unsterile Product; Packaging Problem; Material Split, Cut or Torn; Delivered as Unsterile Product; Packaging Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THERE WAS A "GREASE¿ LOOKING SPOT ON A PART OF THE INNER STERILE PACKAGING AND THE SEAL WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16026976 ↗
• MalfunctionNov 23, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, DURING INSERTION OF INSTRUMENTS, THE SEAL WAS DAMAGED AND THERE WAS EXCESSIVE AIR OR GAS LEAKED FROM THE SEAL. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15858020 ↗
• MalfunctionOct 29, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION, DURING THE ENTIRE PROCEDURE, THE TROCAR DID NOT HOLD PNUEMO WHEN A 5MM INSTRUMENT WAS INSERTED. THE DEVICE LEAKED AIR AND CAN BE HEARD THE ENTIRE CASE. THE SURGEON HAD TO SWITCH OUT TROCARS BECAUSE THE DEVICE COULD NOT KEEP THE ABDOMEN INFLATED. PULLED OUT THE 5MM GRASPER TO TRY AND LET THE ABDOMEN FILL UP WITH PNEUMO AGAIN SO THAT THE SURGEON COULD CONTINUE WITH THE PROCEDURE. WHEN THE TROCAR SEAL LEAKED, THE ABDOMEN DEFLATED AND THE SURGEON CANNOT PERFORMED THE PROCEDURE, IT CAME TO A HALT AND THE SURGEON HAD TO WAIT AGAIN TO INFLATE THE ABDOMEN BEFORE PROCEEDING. THE SURGEON CONTINUED TO OPEN A NEW 8MM TROCARS TO COMPLETE THE PROCEDURE. SOME DEVICE LEAKED MORE THAN THE OTHERS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15696674 ↗
• MalfunctionOct 29, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION, DURING THE ENTIRE PROCEDURE, THE TROCAR DID NOT HOLD PNUEMO WHEN A 5MM INSTRUMENT WAS INSERTED. THE DEVICE LEAKED AIR AND CAN BE HEARD THE ENTIRE CASE. THE SURGEON HAD TO SWITCH OUT TROCARS BECAUSE THE DEVICE COULD NOT KEEP THE ABDOMEN INFLATED. PULLED OUT THE 5MM GRASPER TO TRY AND LET THE ABDOMEN FILL UP WITH PNEUMO AGAIN SO THAT THE SURGEON COULD CONTINUE WITH THE PROCEDURE. WHEN THE TROCAR SEAL LEAKED, THE ABDOMEN DEFLATED AND THE SURGEON CANNOT PERFORMED THE PROCEDURE, IT CAME TO A HALT AND THE SURGEON HAD TO WAIT AGAIN TO INFLATE THE ABDOMEN BEFORE PROCEEDING. THE SURGEON CONTINUED TO OPEN A NEW 8MM TROCARS TO COMPLETE THE PROCEDURE. SOME DEVICE LEAKED MORE THAN THE OTHERS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15696496 ↗
• MalfunctionOct 27, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION, DURING THE ENTIRE PROCEDURE, THE TROCAR DID NOT HOLD PNUEMO WHEN A 5MM INSTRUMENT WAS INSERTED. THE DEVICE LEAKED AIR AND CAN BE HEARD THE ENTIRE CASE. THE SURGEON HAD TO SWITCH OUT TROCARS BECAUSE THE DEVICE COULD NOT KEEP THE ABDOMEN INFLATED. PULLED OUT THE 5MM GRASPER TO TRY AND LET THE ABDOMEN FILL UP WITH PNEUMO AGAIN SO THAT THE SURGEON COULD CONTINUE WITH THE PROCEDURE. WHEN THE TROCAR SEAL LEAKED, THE ABDOMEN DEFLATED AND THE SURGEON CANNOT PERFORMED THE PROCEDURE, IT CAME TO A HALT AND THE SURGEON HAD TO WAIT AGAIN TO INFLATE THE ABDOMEN BEFORE PROCEEDING. THE SURGEON CONTINUED TO OPEN A NEW 8MM TROCARS TO COMPLETE THE PROCEDURE. SOME DEVICE LEAKED MORE THAN THE OTHERS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15681858 ↗
• MalfunctionOct 27, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION, DURING THE ENTIRE PROCEDURE, THE TROCAR DID NOT HOLD PNUEMO WHEN A 5MM INSTRUMENT WAS INSERTED. THE DEVICE LEAKED AIR AND CAN BE HEARD THE ENTIRE CASE. THE SURGEON HAD TO SWITCH OUT TROCARS BECAUSE THE DEVICE COULD NOT KEEP THE ABDOMEN INFLATED. PULLED OUT THE 5MM GRASPER TO TRY AND LET THE ABDOMEN FILL UP WITH PNEUMO AGAIN SO THAT THE SURGEON COULD CONTINUE WITH THE PROCEDURE. WHEN THE TROCAR SEAL LEAKED, THE ABDOMEN DEFLATED AND THE SURGEON CANNOT PERFORMED THE PROCEDURE, IT CAME TO A HALT AND THE SURGEON HAD TO WAIT AGAIN TO INFLATE THE ABDOMEN BEFORE PROCEEDING. THE SURGEON CONTINUED TO OPEN A NEW 8MM TROCARS TO COMPLETE THE PROCEDURE. SOME DEVICE LEAKED MORE THAN THE OTHERS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15681827 ↗