VersaOne ONB12LGF (UDI 10884521657717)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521657717), received between Apr 22, 2019 and Aug 21, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2024Break; Leak/Splash; Material Split, Cut or Torn; Break; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO USE THE SEAL OF THE DEVICE WAS DAMAGED, AIR OR GAS LEAKED FROM THE SEAL AND THE STOPCOCK BROKE FOR ALL FOUR DEVICES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20010821 ↗
• MalfunctionSep 27, 2023Break; Leak/Splash; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Break; Leak/Splash; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC BARIATRIC SLEEVE GASTRECTOMY, THREE TROCARS FROM TWO BARIATRIC KITS HAD ISSUES. THE SEALS WERE DAMAGED, AIR OR GAS LEAKED FROM THE SEALS, AND THE STOPCOCKS BROKE. THE SEALS OF THE TROCARS BROKE OFF AFTER THE INSERTION OF CAMERA AND OTHER INSTRUMENTS. THE SEALS FELL INTO THE PATIENT CAVITY. DUE TO THIS EVENT, THE PNEUMOPERITONEUM WAS LOST, THE TROCARS HAD TO BE REPLACED, AND THE SEAL IN THE PATIENT'S CAVITY HAD TO BE LOOKED FOR AND REMOVED. THE SURGICAL TIME WAS DELAYED FOR FIVE MINUTES DUE TO CHANGING TROCARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17826343 ↗
• MalfunctionMar 24, 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, THERE WAS SOME LEAKING OF THE GAS. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES AS A RESULT. THE PHYSICIAN WAS STILL ABLE TO CONTINUE WITH THE PROCEDURE USING THE SAME DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16610723 ↗
• MalfunctionAug 12, 2021Break; Break

  ACCORDING TO THE REPORTER, AT THE BEGINNING OF A LAPAROSCOPIC RECTOSIGMOIDECTOMY, THE OBTURATOR OR TROCAR BROKE. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315246 ↗
• MalfunctionNov 12, 2019Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC LOW ANTERIOR RESECTION, THE ROBOTIC ARM COULD NOT BE DOCKED "CLAMP-PROOF" ON THE TROCAR. THE CASE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9312009 ↗
• MalfunctionMay 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN THE STAPLING RELOAD WAS INTRODUCED THROUGH THE TROCAR ON A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE DEVICE¿S BLUE RUBBER SEAL DISENGAGED INTO THE PATIENT¿S CAVITY. THEY RETRIEVE THE SEAL THAT FELL INTO THE PATIENT AND OPENED A NEW TROCAR TO FINISH THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8577875 ↗
• MalfunctionApr 22, 2019Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRECTOMY, WHILE SEALING THE VESSEL, THE DEVICE SEAL WAS DAMAGED. ALSO, THE SEALING DEVICE DID NOT SEAL, THERE WERE NO ALARMS HEARD. THE OTHER SEALING DEVICE DID NOT SEAL AS WELL, THOUGH REGRASP ALARMS WERE HEARD AND THERE WERE NO END TONES. THEY THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8536868 ↗