VersaOne ONB12STF (UDI 10884521657687)Recalls & reported problems

Summary

The FDA's MAUDE database contains 531 adverse event reports that list this exact device (DI 10884521657687), received between Feb 3, 2017 and Sep 24, 2026 — classified as 21 injuries, 510 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (331 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 531 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Material Split, Cut or Torn

  According to the reporter, the device seal ruptured during the procedure while in use on the patient.

  Patient problems: Insufficient Information

  MAUDE report 50883990 ↗
• MalfunctionAug 28, 2026Leak/Splash; Material Split, Cut or Torn

  According to the reporter, during a laparoscopic colon lowering, it was observed that the sealing mechanism of the 11 mm disposable trocar failed, making it impossible to maintain the pneumoperitoneum due to recurrent air leakage. Another trocar of the same brandwas exchanged to resolve the issue after making more than three attempts. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50495241 ↗
• MalfunctionAug 24, 2026Break; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50420506 ↗
• MalfunctionAug 10, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50193309 ↗
• MalfunctionAug 7, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50175207 ↗
• MalfunctionAug 7, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50175046 ↗
• MalfunctionAug 5, 2026Leak/Splash; Detachment of Device or Device Component; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147932 ↗
• MalfunctionMay 4, 2026Leak/Splash; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY, THE RING OF THE DEVICE SHIFTED MAKING IT IMPOSSIBLE TO INSERT THE STAPLER INTO THE TROCAR. THE DEVICE ALSO LEAKED SIGNIFICANTLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072430 ↗
• InjuryApr 30, 2026Leak/Splash; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A GYNECOLOGIC LAPAROSCOPY, A TROCAR ACCESS PORT WAS USED FOR ENTRY AND, DURING INSUFFLATION, THE SKIN RAISED AND AIR WAS REPORTED TO HAVE LEAKED FROM THE SEAL, WITH GAS ENTERING AND TRACKING WITHIN THE SUBCUTANEOUS TISSUE CAUSING SUBCUTANEOUS EMPHYSEMA. BRUISING OVER THE ABDOMINAL AREA WAS REPORTED. THE PORT WAS REMOVED AND THE SURGEON RE-ENTERED USING ANOTHER PORT FROM A DIFFERENT MANUFACTURER TO COMPLETE THE CASE. IT WAS ALSO NOTED THAT THE INCISION WAS EXTENDED BY LESS THAN AN INCH. THE SURGEON UPDATED THAT THE PATIENT WAS RE ADMITTED TO THE HOSPITAL WITH PORT SITE HERNIA, AND CURRENTLY THE PATIENT IS UNWELL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bruise/Contusion; Hernia; Laceration(s)

  MAUDE report 25040401 ↗
• InjuryApr 20, 2026Melted; Environmental Particulates

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SURGICAL PROCEDURE, AT THE BEGINNING OF THE SURGERY AND DURING THE LAPAROSCOPY PROCESS USING THE ENERGY PLATFORM AND A NON-MEDTRONIC MONOPOLAR SPATULA, THE ENERGY WAS INITIALLY SET AT 20W FOR PURE CUT AND COAGULATION AND WAS THEN INCREASED TO 30W DUE TO INSUFFICIENT TISSUE EFFECT, AFTER WHICH A MATCH-SIZED FLAME OCCURRED AT THE NON-MEDTRONIC MONOPOLAR INSTRUMENT UPON ACTIVATION VIA THE MONOPOLAR FOOT SWITCH. THE DEVICE ALSO CAUGHT ON FIRE. THE MONOPOLAR INSTRUMENT WAS IMMEDIATELY WITHDRAWN FROM THE PATIENT¿S CAVITY AND DISCONTINUED, AND A DEVICE WAS INTRODUCED; UPON ACTIVATING DEVICE ENERGY INSIDE THE PATIENT¿S CAVITY, AN ENERGY OVERLOAD WAS REPORTED AND THERMAL DAMAGE (BURNING) TO THE SURGICAL CANNULA OCCURRED. THE DEVICE WAS ACTIVATED MULTIPLE TIMES IN SUCCESSION JUST PRIOR TO THE BURN. AN EXPLORATORY LAPAROSCOPIC INSPECTION OF THE ABDOMINAL CAVITY IDENTIFIED THERMAL LESIONS (BURN) ON THE ABDOMINAL WALL WITH ASSOCIATED TISSUE DAMAGE OR UNEXPECTED TISSUE LOSS, AND MELTED POLYMER DEBRIS INSIDE THE ABDOMINAL CAVITY THAT WAS REPORTED TO ORIGINATE FROM THE STRUCTURALLY COMPROMISED CANNULA. THE BURN WAS LOCATED AROUND THE TROCAR AND IN A REGIO

  Patient problems: Laceration(s)

  MAUDE report 24925528 ↗
• MalfunctionApr 2, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC CHOLECYSTECTOMY WITHOUT CHOLANGIOGRAPHY, A DEFECT IN THE SEALING RUBBER WAS NOTED. THE TROCAR WAS CHANGED TO RESOLVE THE ISSUE AND ALLOW COMPLETION OF THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767505 ↗
• MalfunctionMar 19, 2026Leak/Splash; Decrease in Pressure

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HERNIA REPAIR, AT THE TIME OF FORCEPS OPERATION, AIR LEAKED FROM THE SEAL. PNEUMOPERITONEUM LEAKAGE BECAME SEVERE IMMEDIATELY AFTER THE START OF THE SURGERY. A NEW PRODUCT OF THE SAME STANDARD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642840 ↗
• MalfunctionMar 18, 2026Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS, WHEN THE TWO TROCARS WERE PLACED, GAS LEAKED THROUGH THE VALVES, PREVENTING VISUALIZATION. ADDITIONALLY, THE SEAL OF THE DEVICES WERE DAMAGED. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES BECAUSE THE CARBON DIOXIDE COULD NOT ENTER THE CAVITY, PREVENTING THE SURGERY FROM BEGINNING. TO RESOLVE THE ISSUE, ANOTHER BATCH OF THE SAME DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630708 ↗
• MalfunctionMar 18, 2026Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, RIGHT AT THE BEGINNING, WHEN USING THE POWERED STAPLER, THE INTERNAL VALVE RUPTURED, CAUSING A LEAK. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628565 ↗
• MalfunctionMar 16, 2026Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC PROCEDURE, 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 24612311 ↗
• MalfunctionMar 16, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VERTICAL GASTROPLASTY, THE SEAL DISENGAGED AND THE DEVICE LEAKED. THE SEAL FELL INTO THE CAVITY, AND IT WAS RETRIEVED BY USING A LAPAROSCOPIC FORCEPS. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES TO RETRIEVE A NEW DEVICE FROM THE STOREROOM AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604432 ↗
• MalfunctionMar 13, 2026Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS, WHEN THE TWO TROCARS WERE PLACED, GAS LEAKED THROUGH THE VALVES, PREVENTING VISUALIZATION. ADDITIONALLY, THE SEAL OF THE DEVICES WERE DAMAGED. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES BECAUSE THE CARBON DIOXIDE COULD NOT ENTER THE CAVITY, PREVENTING THE SURGERY FROM BEGINNING. TO RESOLVE THE ISSUE, ANOTHER BATCH OF THE SAME DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24595748 ↗
• MalfunctionMar 10, 2026Leak/Splash; Decrease in Pressure

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ENDOMETRIOSIS PROCEDURE, SIGNIFICANT AIR OR GAS LEAKAGE OCCURRED FROM THE SEAL, RESULTING IN LOSS OF PNEUMOPERITONEUM IN THE ABDOMINAL CAVITY. IT WAS NOTED THAT THERE WAS A RAPID LOSS OF PNEUMOPERITONEUM. IMMEDIATE TROCAR REPLACEMENT WAS PERFORMED 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 24562625 ↗
• MalfunctionFeb 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE BLUE SILICONE VALVE BECAME INTRAPERITONEAL, LODGING IN THE PERITONEUM, AND THE CANNULA DETACHED FROM THE TOP PORTION OF THE PORT. IMMEDIATE REMOVAL OF THE INTRAPERITONEAL COMPONENT WAS PERFORMED, AND THE TROCAR WAS CHANGED TO ANOTHER FROM THE SAME LAB BUT A DIFFERENT BATCH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24449209 ↗
• MalfunctionFeb 24, 2026Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC HEPATECTOMY, PNEUMOPERITONEUM LEAKAGE OCCURRED AND THE PRODUCT'S DIAPHRAGM WAS DA MAGED. THE RELOAD JAMMED AT THE MOMENT OF FIRING AND THERE WAS NO FIRING WITH THE 45MM RELOAD USED WITH A POWERED STAPLER. THE ISSUE WAS RESOLVED BY EXCHANGING MATERIALS AND REPLACING THE DEVICE, ALLOWING THE CASE TO BE COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24426814 ↗
• MalfunctionFeb 20, 2026Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPICALLY ASSISTED DISTAL GASTRECTOMY, IMMEDIATELY AFTER INSERTING THE TROCAR, THAT THERE WAS PNEUMOPERITONEUM LEAKAGE. THE SEAL OF THE TROCAR WAS DAMAGED. ANOTHER TROCAR WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24403523 ↗
• MalfunctionFeb 18, 2026Decrease in Pressure

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THERE WAS GAS LEAKAGE AROUND THE SEAL CAUSING LOSS OF PNEUMOPERITONEUM. IT WAS NOTED THAT THERE WAS A RAPID LOSS OF PNEUMOPERITONEUM. THE SURGEON HAD TO DEAL WITH IT AND FINISHED THE CASE WITH A GAS LEAK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24381493 ↗
• MalfunctionFeb 18, 2026Leak/Splash; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROSTATECTOMY, AFTER AN HOUR, IT BEGAN TO LEAK. ANOTHER TROCAR WAS REPLACED BUT THE SAME ISSUE OCCURRED AND BEGAN TO SPURT BLOOD NOT MORE THAN 500CC. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24377784 ↗
• MalfunctionFeb 11, 2026Break; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS SURGERY, THE RELOAD LOCKED ON TISSUE AND COULD NOT BE REMOVED DURING THE SECOND STAPLING UPON RETURNING THE BLADE. ALL INSTRUCTIONS TO UNLOCK THE LOAD WERE FOLLOWED, INCLUDING HOLDING BOTH SIDE BUTTONS TO RESTART, REMOVING AND RECONNECTING THE ROD, AND USING THE KEY TO DISARTICULATE AND OPEN THE DEVICE, BUT THESE ACTIONS WERE UNSUCCESSFUL. THE SURGEON MANUALLY REMOVED THE TISSUE AND PERFORMED SUB-SUTURING AND STAPLE LINE REINFORCEMENT TO RESOLVE THE ISSUE. THE TROCAR EXPERIENCED A VALVE BREAK, CAUSING A LEAK, AND THE LENS DISENGAGED. THE TROCAR WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319671 ↗
• MalfunctionJan 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, DURING ENTRY USING THE TROCAR, THE VALVE SEAL BROKE OFF AND FELL INTO THE PATIENT'S CAVITY. INTERNAL BLEEDING OCCURRED DURING THE SURGERY DUE TO THE BROKEN FOREIGN BODY, RESULTING IN TEMPORARY INJURY AND BLOOD LOSS OF 500CC OR MORE. THE SURGICAL TIME WAS EXTENDED DUE TO THE TEAM SEARCHED FOR THE REDUCER FOR AN HOUR AND THEN STOPPED THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24085761 ↗