VersaOne ONB15STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 174 adverse event reports that list this exact device (DI 10884521185975), received between Mar 2, 2017 and Sep 29, 2026 — classified as 5 injuries, 169 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (107 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 174 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Difficult to Insert; Leak/Splash; Detachment of Device or Device Component

  According to the reporter, during a laparoscopic sleeve gastrectomy procedure using a trocar, while the surgeon was stapling the stomach, resistance was encountered when inserting a stapling device through the trocar. The surgeon had to remove the stapler and align it better with the trocar. During firing, the surgeon observed a loss of pressure in the abdominal space. The surgeon placed a finger over the trocar opening to maintain normal peritoneal pressure. Upon investigation, the trocar seal was found to have become dislodged and fallen into the patient¿s abdominal cavity. The dislodged seal was visualized intraoperatively, retrieved using a grasper, and removed through the trocar. The procedure was completed successfully with no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934713 ↗
• MalfunctionJul 21, 2026Detachment of Device or Device Component

  Patient problems: Insufficient Information

  MAUDE report 25885967 ↗
• MalfunctionMay 26, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, WHEN CONNECTING THE CARBON DIOXIDE HOSE, THE SEAL WAS DAMAGED. THE TROCAR WAS EXCHANGED FOR AN IDENTICAL REPLACEMENT, WHICH REPORTEDLY WORKED WITHOUT ANY PROBLEMS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279532 ↗
• MalfunctionMar 19, 2026

  WHEN INSERTING CATCH BAG INTO TROCAR, THE CATCH BAG BROKE THE SEAL TO THE TROCAR. PLASTIC PIECE GOT STUCK INSIDE THE TROCAR AND DID NOT ENTER ABDOMINAL CAVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638193 ↗
• MalfunctionMar 6, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE BLUE/TRANSLUCENT SEAL HOUSING FELL OUT OF THE DEVICE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532999 ↗
• MalfunctionMar 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC SLEEVE GASTRECTOMY, WHILE FIRING STAPLERS, THE TROCAR EXHIBITED A DISENGAGED SEAL. THE ISSUE WAS RESOLVED BY REPLACING THE TROCAR WITH A NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24526998 ↗
• MalfunctionFeb 24, 2026Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NEPHRECTOMY, IMMEDIATELY AFTER PUNCTURE, THE SEAL WAS DAMAGED. ANOTHER TROCAR WAS U SED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24426774 ↗
• MalfunctionFeb 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE INVOLVING REMOVAL OF A SPECIMEN, THE SEAL OF THE TROCAR BECAME DISENGAGED FROM THE OBTURATOR, AND FELL INTO THE CAVITY OF THE PATIENT. THE SEAL WAS RETRIEVED. THE ISSUE WAS RESOLVED BY USING A NEW TROCAR 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 24345558 ↗
• MalfunctionFeb 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC CYSTECTOMY PROCEDURE, THE ABDOMINAL WALL, THE BLUE SEAL RING DISENGAGED FROM THE TROCAR AND SUBSEQUENTLY FELL INTO THE CAVITY OF THE PATIENT AND WAS RETRIEVED WITH THE USED OF GASPER. THE ISSUE WAS RESOLVED BY USING A NEW TROCAR 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 24328448 ↗
• MalfunctionFeb 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE DEVICE SEAL DETACHED FROM THE TROCAR AND REMAINED STUCK TO THE OPTICS. THE DEVICE WAS REPLACED 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 24290216 ↗
• MalfunctionDec 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A ROBOTIC LAPAROSCOPIC PULMONARY SEGMENTECTOMY, THE BLUE SEAL OF THE TROCAR DISENGAGED. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843392 ↗
• MalfunctionDec 16, 2025Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, AIR OR GAS LEAKED FROM THE SEAL OF THE 15 MILLIMETER (MM) TROCAR WHEN A FIVE MILLIMETER DEVICE WAS INSERTED OR ANGLED. THE LEAK STARTED AS THE SEAL DETACHED. THERE WAS TOO MUCH SPACE SURROUNDING THE INSTRUMENT. TO ADDRESS THE ISSUE, THE SURGEON CHANGED TO A 12MM TOP, WHICH IMPROVED THE SITUATION BUT DID NOT FULLY RESOLVE THE PNEUMOPERITONEUM LEAK. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PLI 30: PRODUCT RECEIVED WITHOUT ACCOMPANYING INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816445 ↗
• MalfunctionDec 8, 2025Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC GASTRIC SLEEVE, BLACK AND PURPLE STAPLE RELOADS WERE PUT THROUGH THE TROCAR INTERMITTENTLY THROUGHOUT THE CASE, WHEN USING THE TROCAR AT THE UMBILICUS PORT, THE PORT WAS LEAKING AND THE BLUE SEAL BECAME DISLODGED FROM THE TROCAR. THE BLUE SEAL HOUSING FELL INTO THE PATIENT'S CAVITY. AFTER REPLACING THE 15MM TROCAR WITH ANOTHER AFTER RETRIEVING THE SPECIMEN, THE SEAL WAS RETRIEVED WITH GRASPERS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23752312 ↗
• MalfunctionNov 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, DURING THE TROCAR INITIAL PLACEMENT STEP, THE SEAL DISENGAGED. NO COMPONENT FELL INTO THE CAVITY OF THE PATIENT. ANOTHER DEVICE 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 23586441 ↗
• MalfunctionNov 10, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC GASTRIC SLEEVE, THE SEAL BROKE WHEN INSERTING A BLACK RELOAD INTO THE TROCAR. ADDITIONALLY, THERE WAS AIR OR GAS LEAKED FROM THE SEAL. THE TROCAR WAS REPLACED BY ANOTHER OF THE SAME SIZE 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 23518556 ↗
• MalfunctionNov 3, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE SEALS OF TWO TROCARS WERE DAMAGED. THE PNEUMOPERITONEUM LEAKED ALMOST IMMEDIATELY FROM THE SEALS, THEN LEAKED WORSE AFTER A STAPLER WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 23450424 ↗
• MalfunctionNov 3, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE SEALS OF TWO TROCARS WERE DAMAGED. THE PNEUMOPERITONEUM LEAKED ALMOST IMMEDIATELY FROM THE SEALS, THEN LEAKED WORSE AFTER A STAPLER WAS USED.

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

  MAUDE report 23450022 ↗
• MalfunctionSep 9, 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 ROBOTIC LAPAROSCOPIC SLEEVE GASTRECTOMY, DURING THE STAPLING STEP, THE TROCAR EXHIBITED A DAMAGED SEAL AND THE GASKET FELL INTO THE CAVITY OF THE PATIENT AND WAS RETRIEVED USING A GRASPER. THE CASE WAS COMPLETED BY OPENING A NEW TROCAR FROM ANOTHER MANUFACTURER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001963 ↗
• MalfunctionAug 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC MYOMECTOMY, DURING THE TRANS OPERATIVE PERIOD IN THE ABDOMINAL WALL AND UMBILICAL INCISION, THE ANTI-LEAK SEAL OF THE TROCAR FELL INTO THE ABDOMINAL CAVITY OF THE PATIENT AND THE SEAL WAS FOUND TO BE DAMAGED. THE ANTI-LEAK SEAL WAS IMMEDIATELY REMOVED UNDER LAPAROSCOPIC VISION. THE TROCAR WAS REPLACED BY ANOTHER OF THE SAME MODEL 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 22750345 ↗
• MalfunctionAug 4, 2025Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC GASTROPLASTY, AFTER STAPLING THE STOMACH PYLORUS, WHEN REMOVING THE STAPLER, THE SEALING RING BECAME LOOSE CAUSING A GAS LEAK. ANOTHER IDENTICAL MODEL WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709608 ↗
• MalfunctionJul 11, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC SLEEVE, WHEN INTRODUCING THE TROCAR AND CREATING THE FILTER PNEUMOPERITONEUM IMMEDIATELY, THE SURGEON REMOVED THE OBTURATOR, AND THE CO2 WAS IMMEDIATELY FILTERED. THE SEAL WAS DAMAGED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479846 ↗
• MalfunctionMay 16, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TROCAR BROKE. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22033868 ↗
• MalfunctionApr 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC SLEEVE GASTRECTOMY, DURING THE INSERTION OF THE ENDOSCOPIC STAPLER, THE VALVE SEAL DISENGAGED. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860261 ↗
• MalfunctionJan 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PROCEDURE, WHILE STARTING, THE VALVE DISENGAGED. ANOTHER DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21288902 ↗
• MalfunctionJan 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A PANCREATICODUODENECTOMY A STRONG IMPACT WAS GENERATED ON THE END OF THE VALVE, DAMAGING THE VALVE SEAL. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159379 ↗