VersaOne ONB12SHFRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10884521657700), received between Nov 16, 2017 and Feb 2, 2026 — classified as 1 injury, 35 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (17 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, AFTER A LAPAROSCOPIC TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE WAS COMPLETED, THE SURGICAL TEAM ATTEMPTED TO RE-INFLATE THE ABDOMEN TO CHECK FOR BLEEDING, THE SURGEON INSERTED THE SCOPE INTO THE CAMERA PORT OF THE TROCAR AND FOUND A BLUE FOREIGN OBJECT. THE SURGICAL TEAM NOTED THAT THE OBJECT MIGHT BE A PIECE OF EQUIPMENT RESULTING FROM DAMAGE TO THE SEAL OF TROCAR OR A FRAGMENT DETACHED FROM THE GLOVES INCLUDED WITH THE FOLEY TRAY. TO RESOLVE THE ISSUE, THE PROCEDURE CONCLUDED WITH THE COLLECTION OF THE GLOVES USED DURING THE CASE AND THE DISPOSABLE SUPPLIES USED WITH THE PORT DEVICE AND THE FOREIGN OBJECT WAS RETRIEVED, THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241908 ↗
• MalfunctionJan 28, 2026Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING PREPARATION, THE SEAL WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24198697 ↗
• MalfunctionOct 27, 2025Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPY DISTAL GASTRECTOMY, THERE WAS A RAPID AND SEVERE PNEUMOPERITONEUM LEAK THAT THE PNEUMOPERITONEUM PRESSURE COULD NOT BE MAINTAINED WHEN THE TROCAR INSERTION FORCEPS WAS PASSED THROUGH. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393449 ↗
• MalfunctionOct 21, 2025Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC GASTRECTOMY, AFTER THE TROCAR INSERTION, WHEN THE FORCEPS WAS INSERTED AND OPERATED, THERE WAS A PNEUMOPERITONEUM LEAK SO SEVERE IT COULD NOT BE MAINTAINED. THERE WAS SUDDEN, RAPID LOSS OF PNEUMOPERITONEUM. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23349040 ↗
• MalfunctionJun 27, 2025Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE OBTURATOR AND CANNULA (SLEEVE) COULD NOT BE DOCKED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22349589 ↗
• MalfunctionFeb 20, 2025Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, IN THE TROCAR PUNCTURE IMMEDIATELY AFTER THE START OF THE OPERATION, THE OBTURATOR (INNER TUBE) COULD NOT BE REMOVED OR DETACHED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428731 ↗
• MalfunctionSep 17, 2024Leak/Splash; Decrease in Pressure; Noise, Audible; Leak/Splash; Decrease in Pressure; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTAL RESECTION, APPROXIMATELY FIVE HOURS AFTER THE START OF THE SURGERY, AN AIR LEAK OCCURRED WITH A SOUND DUE TO THE PNEUMOPERITONEUM COULD NOT BE MAINTAINED. THERE WAS A RAPID LOSS OF ABDOMINAL PRESSURE DUE TO THE DEVICE ISSUE. THE TWO LEAKING TROCARS WERE REPLACED WITH NEW ONES TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239840 ↗
• MalfunctionJun 5, 2024Device Contamination with Chemical or Other Material; Material Split, Cut or Torn; Device Contamination with Chemical or Other Material; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE, THE TROCAR SEAL WAS DAMAGED AND THERE WAS A FOREIGN OBJECT, SOMETHING LIKE A TAPE WAS ATTACHED ON THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19468401 ↗
• MalfunctionMay 16, 2024Detachment 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 GASTRECTOMY, WHEN THE FORCEPS WERE INSERTED AND REMOVED, THE SEAL PART GOT DAMAGED, AND THE DAMAGED SEAL PART DROPPED INTO THE ABDOMINAL CAVITY. TO RESOLVE THE ISSUE, THE DAMAGED SEAL PART WAS COLLECTED LAPAROSCOPICALLY USING FORCEPS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19332417 ↗
• MalfunctionMay 8, 2024Device Contamination with Chemical or Other Material; Material Split, Cut or Torn; Device Contamination with Chemical or Other Material; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SEAL WAS DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19268444 ↗
• MalfunctionNov 29, 2023Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY, THE FORCEPS COULD NOT BE INSERTED AND REMOVED SMOOTHLY, THE SEAL WAS DAMAGED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18225556 ↗
• MalfunctionOct 10, 2023Detachment 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 LAPAROSCOPIC GASTRECTOMY, AT UPPER PANCREATIC BORDER DISSECTION, THE VALVE SEAL BROKE PARTIALLY AND FELL INTO THE PATIENT. THE COMPONENT WAS RETRIEVED USING FORCEPS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17907169 ↗
• MalfunctionAug 16, 2023Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTAL RESECTION, AIR LEAKED FROM THE TROCAR AND THERE WAS RAPID LOSS OF PNEUMOPERITONEUM. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17558208 ↗
• MalfunctionAug 4, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOID COLECTOMY, AIR LEAKED FROM THE DEVICE DURING DISSECTION IN THE AREA AROUND THE INFERIOR MESENTERIC ARTERY. WHEN THE HEAD OF THE TROCAR WAS REMOVED, IT WAS FOUND THAT THERE WAS A DAMAGE IN THE INNER 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 17466331 ↗
• MalfunctionJan 25, 2023Detachment 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, ON A LAPAROSCOPIC LEFT HEMICOLECTOMY, WHEN REMOVING THE TROCAR AT THE FINAL STAGE OF OPERATION, THE SEAL WAS DAMAGED. THE TIP OF THE OUTER TUBE FELL INTO THE PATIENT'S ABDOMINAL CAVITY AND WAS RETRIEVED WITH FORCEPS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16239997 ↗
• MalfunctionFeb 3, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING FORCEPS OPERATION IN A LAPAROSCOPIC PARTIAL LIVER RESECTION, THERE WAS A PNEUMOPERITONEUM GAS LEAK AFTER THE FORCEPS WERE INSERTED SEVERAL TIMES. IT WAS CONFIRMED THAT THERE WERE CRACKS IN THE SEAL AREA. IT WAS NOTED THAT THERE WAS NO DROP OF DEBRIS INSIDE THE BODY DUE TO DAMAGE TO THE SEAL. TO RESOLVE THE ISSUE, ANEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13440410 ↗
• MalfunctionJan 27, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRECTOMY, INTRAPERITONEAL WORK WAS PERFORMED. AFTER ABOUT 30 MINUTES OF USE, THE SEAL PART WAS DAMAGED AND AN AIR LEAK WAS NOTICED. THE USER CHANGED TO ANOTHER TROCAR TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13366009 ↗
• MalfunctionDec 29, 2021Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, AN HOUR AFTER THE START OF LAPAROSCOPIC LOW ANTERIOR RESECTION, THE SEAL OF THE DEVICE BROKE HAD AIR/GAS LEAKAGE. THE PNEUMOPERITONEUM COULD NOT BE MAINTAINED, SO A NEW PORT WAS TAKEN OUT. THE OPERATION WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13111247 ↗
• MalfunctionOct 26, 2021Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RECTAL AMPUTATION, THE SEAL BROKE ONE HOUR AFTER INSERTION. AIR LEAKAGE CAUSED REPLACEMENT WITH A NEW TROCAR. NO PATIENT INJURY.

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

  MAUDE report 12700245 ↗
• MalfunctionAug 22, 2021Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING THE MIDDLE OF A PROCEDURE, THERE WAS SEAL BREAKAGE AND AN AIR LEAK OCCURRED. TO RESOLVE THE ISSUE, A NEW PORT WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 12352096 ↗
• MalfunctionAug 12, 2021Break; Leak/Splash; Break; Leak/Splash

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THERE WAS AIR LEAKAGE, THE SEAL PART GOT DAMAGED BY THE FORCEPS AND CLIP. THE SPECIFIC REASON FOR THE DAMAGE WAS UNKNOWN. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 12315261 ↗
• MalfunctionJul 14, 2021Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NEPHRECTOMY, THE SEAL PART GOT DAMAGED AND ABOUT 2MMX2MM OF BROKEN PIECE DROPPED INTO THE ABDOMINAL CAVITY. THE DEVICE WAS USED AS IT WAS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12168699 ↗
• MalfunctionApr 2, 2021Device Misassembled During Manufacturing /Shipping; Packaging Problem; Device Misassembled During Manufacturing /Shipping; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC OVARIAN CYSTECTOMY, WHEN SETTING UP TROCAR, THE CANNULA BROKE IN ADDITION, THE SLEEVE INCLUDED IN THE PACKAGE WAS FROM A DIFFERENT PRODUCT ID. ANOTHER DEVICE 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 11607824 ↗
• MalfunctionSep 22, 2019Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE OBTURATORS WERE UNABLE TO BE TAKEN OUT OR INSERTED SMOOTHLY BY THE DOCTOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9102225 ↗
• InjuryJul 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN A SLIGHTLY WIDER CLIP APPLIER WAS REMOVE-INSERTED THROUGH THE TROCAR, THE BLUE VALVE INSIDE THE TROCAR BROKE. IT WAS FOUND TO HAVE BEEN ATTACHED TO THE TIP OF THE CLIP APPLIER, BUT THEN WENT MISSING. THE PART FELL INTO THE PATIENT'S CAVITY AND COULD NOT BE RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8823470 ↗