VersaOne ONB12STF (UDI 10884521181335)Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10884521181335), received between Aug 18, 2016 and Oct 23, 2025 — classified as 4 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (26 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 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Difficult to Insert; Detachment of Device or Device Component; Material Split, Cut or Torn; Difficult to Insert; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC ILEOCECAL RESECTION, IN THE EARLY STAGES OF SURGERY, WHEN THE INSTRUMENT WAS INSERTED THROUGH THE PORT AND THE PERITONEUM WAS BEING INCISED, THE TROCAR WAS INSERTED AND REMOVED SEVERAL TIMES, HOWEVER, IT WAS HARDER TO INSERT AND REMOVE THAN USUAL. WHEN THE SEAL PART WAS CHECKED, IT WAS FOUND THAT THE HOLE FOR INSERTING THE INSTRUMENT WITH THE SEAL WAS DAMAGED AND SHIFTED OR MISALIGNED TO THE SIDE MORE THAN USUAL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376257 ↗
• MalfunctionOct 17, 2025Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, THE TROCAR EXPERIENCED A SEAL LEAK, RESULTING IN THE RAPID LOSS OF ALL PNEUMOPERITONEUM AND A LOSS OF INSUFFLATION. THE CASE WAS STOPPED OPERATING TIME FOR THREE MINUTES. THE DEVICE CAP REQUIRED REPLACEMENT DURING THE PROCEDURE, AND BOTH 15MM AND 12MM TROCARS WERE INVOLVED. THE TEAM ATTEMPTED TO RESOLVE THE ISSUE BY REMOVINGTHE CAP FROM THE 12MM TROCAR, WHICH DID NOT RESTORE INSUFFLATION, AND THEN REINSERTED IT INTO THE 15MM TROCAR AND RESTARTED INSUFFLATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23330570 ↗
• MalfunctionSep 18, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC BARIATRIC PROCEDURE, THE SEAL OF THE TROCAR WAS DAMAGED AND GAS LEAKED FROM THE SEAL MIDWAY THROUGH THE SURGICAL PROCEDURE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23081519 ↗
• MalfunctionAug 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE FOR APPENDICITIS, DAMAGED SEALS WERE IDENTIFIED ON THE TWO DEVICES DURING TROCAR INSERTION. A NEW 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 22851111 ↗
• MalfunctionNov 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN THE STAPLER WAS INTRODUCED INTO THE TROCAR, THE BLUE PART POSITIONED AT THE ENTRANCE CAME LOOSE AND FELL INTO THE ABDOMINAL CAVITY.

  Patient problems: Insufficient Information

  MAUDE report 20800897 ↗
• MalfunctionFeb 8, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, AT THE TIME OF INCISION, THERE WAS A DAMAGED SEAL, AND AIR OR GAS LEAKED FROM THE SEAL. TO RESOLVE THE ISSUE, THE SURGEON CONTINUED USING THE TROCAR, AND TAKE A LAP AND WILL STUFF IT AROUND THE INSTRUMENT THAT WAS INSERTED TO HELP MAINTAIN PNEUMOPERITONEUM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18672795 ↗
• MalfunctionJan 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MINI GASTRIC BYPASS, THE SEAL WAS DAMAGED. OPENED ANOTHER DEVICE FROM A DIFFERENT MANUFACTURER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18481192 ↗
• MalfunctionDec 15, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC OOPHORECTOMY, THE MEMBRANE OF THE DEVICE WAS DAMAGED, AIR OR GAS LEAKED FROM THE SEAL OF THE DEVICE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18339030 ↗
• MalfunctionNov 10, 2023Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO A LAPAROSCOPIC FUNDOPLICATION, AT THE START OF THE PROCEDURE, THE CANNULA BROKE WHEN INTRODUCING THE TROCAR. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18115912 ↗
• MalfunctionNov 1, 2023Decrease in Pressure; Detachment of Device or Device Component; Material Split, Cut or Torn; Decrease in Pressure; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, THE SEAL WAS GETTING DAMAGE ON THE 12 MILLIMETER TROCAR, AFTER PROLONGED USE AND INSTRUMENT EXCHANGE ESPECIALLY WITH POWERED STAPLER AND 10 MILLIMETER CLIP APPLIER, THE SEAL IS NOT HOLDING UP, IT WAS TEARING AND NOT COMING COMPLETELY OFF, THE SEAL ON TROCAR STARTED LOSING PNEUMO MIDWAY THROUGH PROCEDURE. THE SURGEON MANAGE THE PRESSURE THROUGHOUT REMAINDER OF CASE. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18051857 ↗
• MalfunctionAug 2, 2023Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRECTOMY, AIR LEAKED FROM THE TROCAR SO MUCH THAT IT COULD BE FELT IN THE HAND. THE ISSUE LED TO RAPID LOSS OF PNEUMOPERITONEUM. 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 17443862 ↗
• MalfunctionJun 30, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC GASTRECTOMY, WHEN A 5 MM FORCEPS WERE INSERTED, THE PNEUMOPERITONEUM LEAKED, AND THE TROCAR COULD NO LONGER BE USED. THE SEAL WAS DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237514 ↗
• MalfunctionJun 15, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, LAPAROSCOPIC PROCEDURE, THE SEAL WAS DAMAGED. AFTER PASSING THE INSTRUMENT THROUGH THE PORTAL, THE VALVE WAS NOT SEALING, PRESENTING GAS LOSS AND CONSEQUENTLY UNABLE TO PROCEED WITH THE SURGERY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134354 ↗
• MalfunctionApr 13, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC BARIATRIC SURGERY AND HERNIA REPAIR, WHILE BEING APPLIED IN THE ABDOMEN, THERE WAS AN AIR OR GAS LEAKED FROM THE SEAL FOR BOTH DEVICES. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES SINCE THE SURGEON HAD TO MAKE SEVERAL ATTEMPTS WITH THE INSTRUMENTS AND EVEN PLACE GAUZE TO PREVENT THE GAS FROM LEAKING. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16734435 ↗
• MalfunctionSep 29, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RESECTION, AT MESENTERIC DETACHMENT, THE VALVE WAS DAMAGED, CAUSING AIR LEAKAGE ABOUT FIVE MINUTES AFTER THE START OF THE PROCEDURE. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15502116 ↗
• MalfunctionDec 28, 2021Leak/Splash; Noise, Audible; Material Split, Cut or Torn; Leak/Splash; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE TROCAR SEAL WAS DAMAGED. THE DEVICE WAS LEAKING AND CREATING A LOUD SOUND.

  Patient problems: Insufficient Information

  MAUDE report 13093494 ↗
• MalfunctionDec 7, 2021Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO REPORTER, DURING A PROCEDURE, THE TROCAR WAS LEAKING AND THE SEAL WAS DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 12951731 ↗
• MalfunctionDec 7, 2021Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC BARIATRIC SURGERY, WHEN PUTTING ON THE VIDEO TWEEZERS, THE SEAL WAS DAMAGED AND LEAKING WAS CONTINUOUS. THE SURGEON CONTINUED USING THE REPORTED DEVICE THROUGHOUT THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12945987 ↗
• MalfunctionNov 2, 2021Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, THE TROCAR WAS INSTALLED TO THE PATIENT WITHOUT INCIDENT, BUT AT THE TIME THE STAPLER ENTERED THE TROCAR MEMBRANE, THE SEAL RUPTURED AND BEGAN TO LEAK CARBON DIOXIDE. ANOTHER PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12738840 ↗
• MalfunctionOct 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING ROBOTIC LAPAROSCOPIC PARTIAL NEPHRECTOMY, THE SEAL CAME APART FROM THE CANNULA WHILE THE SURGEON WAS PASSING A NEEDLE THROUGH THE PORT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12658837 ↗
• MalfunctionOct 5, 2021Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SEAL WAS DAMAGED CAUSING A LEAKAGE OF CO2.

  Patient problems: Insufficient Information

  MAUDE report 12577111 ↗
• InjurySep 13, 2021Break; Decrease in Pressure; Noise, Audible; Break; Decrease in Pressure; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BYPASS, THE FIVE INSTRUMENTS MADE STRANGE NOISE AND DUE TO ENTERING OF DIFFERENT SIZE OF DEVICES, THE SEAL FIRST WAS EXTENDED AND THEN BROKE. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE RAPID LOSS OF PNEUMOPERITONEUM. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12465619 ↗
• MalfunctionAug 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING GYNECOLOGICAL LAPAROSCOPIC ADNEXAL RESECTION, THE DEVICE HAD AN ISSUE WHEN INSERTING A PORT AND INSERTING LIGASURE. THE DEVICE HAD SEAL DAMAGE. INSPECTING THE ABDOMINAL CAVITY WITH A CAMERA, IT WAS NOTICED THAT A BLUE FOREIGN MATERIAL WAS ATTACHED TO THE ABDOMINAL WALL. THE PLASTIC THAT WAS USED TO ORGANIZE THE OPTICAL TROCAR OR LIGASURE CORD MAY HAVE SLIGHTLY ATTACHED TO THE TIP DUE TO FRICTION, WHICH MIGHT HAVE FALLEN INTO THE CAVITY. THE DROPPED MATERIAL WAS REMOVED WITH FORCEPS. IF THE FOREIGN MATERIAL WAS NOT A COVIDIEN PRODUCT, THE CAUSE WAS BELIEVED TO BE THE OTHER MANUFACTURER'S TROCAR. THE HOSPITAL THOUGHT IT WAS NOT A PROBLEM WITH THE MAIN UNIT, SO ONLY THE VINYL WAS RETURNED. THE MAIN UNIT OF LIGASURE HAS ALREADY BEEN DISPOSED OF. THE CAPSULE WAS OPENED AT THE START OF THE EXAMINATION, BUT IT DID NOT ILLUMINATE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12269379 ↗
• MalfunctionJun 29, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING RIGHT COLECTOMY, THE DEVICE WAS DIFFICULT TO ARTICULATE. THE JOINT FROM THE RELOAD BROKE OFF. THE ADAPTER ALSO COULD NOT BE REMOVED FROM THE TROCAR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089640 ↗
• MalfunctionMay 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPY, WHEN THE TROCAR WAS IN THE PATIENT, THE RUBBER SEAL DISENGAGED AND FELL INTO THE PATIENT CAVITY AND WAS RETRIEVED WITH LAPAROSCOPIC INSTRUMENTS. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11892505 ↗