VersaOne NONB15STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10884521548091), received between Dec 8, 2016 and Oct 27, 2024 — classified as 3 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (20 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTROPLASTY (SLEEVE) PROCEDURE, THE MEMBRANE OF THE TROCAR FELL OFF WHEN REMOVING THE STAPLER. THE POWERED DEVICE THEN STOPPED WHILE REMOVING THE RECHARGE, SHOWING AN EXCLAMATION MARK ON THE DISPLAY. NO COMPONENT FELL INTO THE PATIENT'S CAVITY. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20541501 ↗
• MalfunctionSep 17, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHEN INSERTING THE 5MM DEVICE IN THE 15MM TROCAR, GAS LEAKED FROM THE SEAL AND THE SEAL WAS DAMAGED. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238414 ↗
• MalfunctionJul 3, 2024Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SEAL DISENGAGED INTO THE CAVITY. AIR OR GAS LEAKED FROM THE SEAL. THE SEAL WAS RETRIEVED FROM THE CAVITY WITH GRASPERS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19668305 ↗
• MalfunctionFeb 21, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN BUILDING UP THE PNEUMOPERITONEUM, THE OPTICAL AND BLADELESS TROCARS WERE NOT ABLE TO KEEP THE PNEUMOPERITONEUM STABLE. CARBON DIOXIDE (C02) ESCAPES AND BLOWS INTO THE SURGEON'S FACES. MOREOVER, THE SIX 15MM BLADELESS TROCARS WERE TRIED AND DID NOT KEEP THE PNEUMOPERITONEUM STABLE. ANOTHER 15MM BLADELESS TROCAR WITH A DIFFERENT LOT WAS USED BUT ALSO DID NOT HOLD THE AIR. IT WAS NOTED THAT ALL THE TROCARS HAD A DAMAGED SEAL. ANOTHER TROCARS WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754364 ↗
• MalfunctionFeb 21, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN BUILDING UP THE PNEUMOPERITONEUM, THE TROCARS WERE NOT ABLE TO KEEP THE PNEUMOPERITONEUM STABLE. CARBON DIOXIDE (C02) ESCAPES AND BLOWS INTO THE SURGEON'S FACES. IT WAS NOTED THAT ALL THE TROCARS HAD A DAMAGED SEAL. ANOTHER TROCARS WERE USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 18754257 ↗
• MalfunctionFeb 20, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN BUILDING UP THE PNEUMOPERITONEUM, THE OPTICAL AND BLADELESS TROCARS WERE NOT ABLE TO KEEP THE PNEUMOPERITONEUM STABLE. CARBON DIOXIDE (C02) ESCAPES AND BLOWS INTO THE SURGEON'S FACES. MOREOVER, THE SIX 15MM BLADELESS TROCARS WERE TRIED AND DID NOT KEEP THE PNEUMOPERITONEUM STABLE. ANOTHER 15MM BLADELESS TROCAR WITH A DIFFERENT LOT WAS USED BUT ALSO DID NOT HOLD THE AIR. IT WAS NOTED THAT ALL THE TROCARS HAD A DAMAGED SEAL. ANOTHER TROCARS WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18744422 ↗
• MalfunctionFeb 20, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN BUILDING UP THE PNEUMOPERITONEUM, THE OPTICAL AND BLADELESS TROCARS WERE NOT ABLE TO KEEP THE PNEUMOPERITONEUM STABLE. CARBON DIOXIDE (C02) ESCAPES AND BLOWS INTO THE SURGEON'S FACES. MOREOVER, THE SIX 15MM BLADELESS TROCARS WERE TRIED AND DID NOT KEEP THE PNEUMOPERITONEUM STABLE. ANOTHER 15MM BLADELESS TROCAR WITH A DIFFERENT LOT WAS USED BUT ALSO DID NOT HOLD THE AIR. IT WAS NOTED THAT ALL THE TROCARS HAD A DAMAGED SEAL. ANOTHER TROCARS WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18744405 ↗
• MalfunctionFeb 20, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN BUILDING UP THE PNEUMOPERITONEUM, THE OPTICAL AND BLADELESS TROCARS WERE NOT ABLE TO KEEP THE PNEUMOPERITONEUM STABLE. CARBON DIOXIDE (C02) ESCAPES AND BLOWS INTO THE SURGEON'S FACES. MOREOVER, THE SIX 15MM BLADELESS TROCARS WERE TRIED AND DID NOT KEEP THE PNEUMOPERITONEUM STABLE. ANOTHER 15MM BLADELESS TROCAR WITH A DIFFERENT LOT WAS USED BUT ALSO DID NOT HOLD THE AIR. IT WAS NOTED THAT ALL THE TROCARS HAD A DAMAGED SEAL. ANOTHER TROCARS WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18744364 ↗
• MalfunctionFeb 20, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN BUILDING UP THE PNEUMOPERITONEUM, THE OPTICAL AND BLADELESS TROCARS WERE NOT ABLE TO KEEP THE PNEUMOPERITONEUM STABLE. CARBON DIOXIDE (C02) ESCAPES AND BLOWS INTO THE SURGEON'S FACES. MOREOVER, THE SIX 15MM BLADELESS TROCARS WERE TRIED AND DID NOT KEEP THE PNEUMOPERITONEUM STABLE. ANOTHER 15MM BLADELESS TROCAR WITH A DIFFERENT LOT WAS USED BUT ALSO DID NOT HOLD THE AIR. IT WAS NOTED THAT ALL THE TROCARS HAD A DAMAGED SEAL. ANOTHER TROCARS WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18744344 ↗
• MalfunctionFeb 20, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN BUILDING UP THE PNEUMOPERITONEUM, THE OPTICAL AND BLADELESS TROCARS WERE NOT ABLE TO KEEP THE PNEUMOPERITONEUM STABLE. CARBON DIOXIDE (C02) ESCAPES AND BLOWS INTO THE SURGEON'S FACES. MOREOVER, THE SIX 15MM BLADELESS TROCARS WERE TRIED AND DID NOT KEEP THE PNEUMOPERITONEUM STABLE. ANOTHER 15MM BLADELESS TROCAR WITH A DIFFERENT LOT WAS USED BUT ALSO DID NOT HOLD THE AIR. IT WAS NOTED THAT ALL THE TROCARS HAD A DAMAGED SEAL. ANOTHER TROCARS WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18744330 ↗
• MalfunctionFeb 20, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN BUILDING UP THE PNEUMOPERITONEUM, THE OPTICAL AND BLADELESS TROCARS WERE NOT ABLE TO KEEP THE PNEUMOPERITONEUM STABLE. CARBON DIOXIDE (C02) ESCAPES AND BLOWS INTO THE SURGEON'S FACES. MOREOVER, THE SIX 15MM BLADELESS TROCARS WERE TRIED AND DID NOT KEEP THE PNEUMOPERITONEUM STABLE. ANOTHER 15MM BLADELESS TROCAR WITH A DIFFERENT LOT WAS USED BUT ALSO DID NOT HOLD THE AIR. IT WAS NOTED THAT ALL THE TROCARS HAD A DAMAGED SEAL. ANOTHER TROCARS WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18744250 ↗
• MalfunctionDec 11, 2023

  SEALS ON VERSAONE BLADELESS TROCAR WITH FIXATION CANNULA X 2 ARE LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18300606 ↗
• InjuryMay 10, 2023Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE CANNULA TIP BROKE OR SNIPPED OFF. WHEN THE SURGEON PULLED OUT THE TROCARS TO CLOSE THE ABDOMEN, IT WAS NOTICED THAT A PIECE WAS MISSING OFF THE CANNULA TIP OF THE REPORTED TROCAR. AN XRAY WAS PERFORMED TO SEE IF THE TROCAR TIP WAS INSIDE THE ABDOMEN BUT IT WAS NOT FOUND. THE SURGICAL TIME WAS EXTENDED FOR 25 MINUTES DUE TO THE PRODUCT PROBLEM.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 16903953 ↗
• MalfunctionMay 3, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE PROCEDURE, THE SEAL TO BE LIFTED INSIDE THE TROCAR WAS TORN WHEN AN INSTRUMENT (MANUAL STAPLER) WAS REMOVED. RESULTING IN A DEFECT IN PRODUCT SEALING AND THE RISK THAT THE SEAL WILL REMAIN IN THE VISCERA OF THE OPERATED PATIENT. THE TROCAR WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16862128 ↗
• MalfunctionMar 17, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE SEAL WAS DAMAGED AND AIR EXCESSIVELY LEAKED OUT WHEN A 5MM INSTRUMENT WAS BEING USED AND INSERTED; THIS LED TO THE TANK OF GAS TO BE USED UP. THE SURGEON USED A NEW TROCAR AND NEW GAS TANK TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13791039 ↗
• MalfunctionMar 10, 2022Difficult to Insert; Leak/Splash; Difficult to Insert; Leak/Splash

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC DUODENAL SWITCH, THE SEAL BECAME INCREASINGLY DIFFICULT TO PASS THE STAPLER THROUGH IT. THE DEVICE WAS STICKY AND GRABBING THE SMOOTH SHAFT OF THE STAPLER MAKING IT DIFFICULT TO SLIDE THE STAPLER. SURGEON HAD TO USE EXTRA FORCE TO PUSH THE DEVICE INTO POSITION. THIS HAPPENED WITH MULTIPLE FIRING OF STAPLER. EACH USE NEEDED AN INCREASE FORCE TO PASS THE INSTRUMENT. ADDITIONALLY, THE SEAL WAS LEAKING GAS. THE SURGEON HAD TO REPLACED IT WITH A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13721142 ↗
• MalfunctionMar 10, 2022Leak/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 DUODENAL-JEJUNAL BYPASS WITH SLEEVE GASTRECTOMY, WHILE INSERTING THE STAPLING INSTRUMENT THROUGH THE DEVICE, THE SEAL WAS DAMAGED AND WAS DISENGAGED CAUSING AIR TO LEAK FROM THE SEAL. THE SURGEON USED A NEW TROCAR WRAPPED WITH GAUZE TO MAINTAIN PNEUMO AND RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13720430 ↗
• MalfunctionDec 29, 2021Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING AN OPEN GASTROPLASTY PROCEDURE, THE DEVICE WAS DEFECTIVE. A PIECE WAS PUT INTO THE PATIENT AND THE OPTIC WAS UNABLE TO ENTER. THE PRODUCT WAS REPLACED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13110415 ↗
• MalfunctionDec 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, WHEN INSERTING THE STAPLER, THE SEAL OF THE DEVICE DISENGAGED. THE DEVICE WAS REPLACED IN ORDER TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010043 ↗
• MalfunctionDec 15, 2021Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC DUODENAL SWITCH SURGERY, THE SURGEON HAD DIFFICULTY INSERTING INSTRUMENTS THROUGH THE PORT AND THE SEAL WAS DAMAGED. THE SURGEON USED ANOTHER TROCAR TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010022 ↗
• MalfunctionDec 7, 2021Leak/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 SLEEVE GASTRECTOMY, THE SEAL WAS LEAKING. WHILE INSERTING THE STAPLER, THE BLUE SEAL WAS DAMAGED AND DISENGAGED AND ENDED UP INSIDE THE PATIENT CAVITY. THE SURGEON RETRIEVED THE SEAL WITH A GRASPER TO RESOLVE THE ISSUE AND ANOTHER TROCAR WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12952190 ↗
• MalfunctionNov 24, 2021Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHEN INSERTING THE STAPLER INTO THE TROCAR TO STAPLE THE TISSUE, THE SEAL WAS DAMAGED AND DISENGAGED, THE BLUE VALVE BROKE OFF AND STUCK INTO THE STAPLER AND FELL INTO THE PATIENT CAVITY. THE USER PULLED THE STAPLER BACK OUT WITH BLUE VALVE PIECE STUCK ON IT TO RETRIEVE THE COMPONENT. THE OPERATOR GOT ANOTHER TROCAR TO COMPLETE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868492 ↗
• MalfunctionOct 27, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, A PIECE OF THE 15MM TROCAR THAT WAS INSIDE THE PATIENT BROKE OFF. ALL PIECES WERE REMOVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 12706754 ↗
• MalfunctionOct 5, 2021Break

  DURING THE LAPAROSCOPIC SURGICAL PROCEDURE A PIECE OF THE 15MM TROCAR THAT WAS INSIDE THE PATIENT BROKE OFF.

  Patient problems: Foreign Body In Patient

  MAUDE report 12576024 ↗
• MalfunctionJan 12, 2021Decrease in Pressure; Decrease in Pressure

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTROPLASTY, AFTER THE STAPLER PASSED THROUGH THE ACCESS, INTENSE LEAKS OCCURRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11154367 ↗