VersaOne NONB5STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10884521546844), received between Nov 15, 2017 and Feb 5, 2026 — classified as 5 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 5, 2026Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, BOTH TROCARS LEAKED TOWARDS THE END OF THE CASE. THE BLUE SEAL OF THE FIRST TROCAR WAS PARTIALLY PUSHED DOWN, CAUSING THE LEAK. THE SURGEON PLACED A FINGER ON THE SIDE OF THE TROCAR TO REDUCE AIR LOSS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268548 ↗
• MalfunctionDec 3, 2025Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MYOMECTOMY PROCEDURE, TWO DEVICES HAD A DIFFICULTY WITH SMOOTH INSERTION AND REMOVAL. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708646 ↗
• MalfunctionDec 3, 2025Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MYOMECTOMY PROCEDURE, TWO DEVICES HAD A DIFFICULTY WITH SMOOTH INSERTION AND REMOVAL. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708630 ↗
• MalfunctionApr 4, 2025Product Quality Problem; Material Split, Cut or Torn; Product Quality Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, A FILM WAS DISCOVERED ON THE MEMBRANE OF THE TROCAR. IT WAS NOTED THAT SIX TROCARS WAS USED AND HAD THE SAME ISSUE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21771160 ↗
• MalfunctionApr 4, 2025Product Quality Problem; Material Split, Cut or Torn; Product Quality Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, A FILM WAS DISCOVERED ON THE MEMBRANE OF THE TROCAR. IT WAS NOTED THAT SIX TROCARS WAS USED AND HAD THE SAME ISSUE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21771145 ↗
• MalfunctionApr 4, 2025Product Quality Problem; Material Split, Cut or Torn; Product Quality Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, A FILM WAS DISCOVERED ON THE MEMBRANE OF THE TROCAR, THE SEAL WAS DAMAGED. IT WAS NOTED THAT SIX TROCARS WERE USED AND HAD THE SAME ISSUE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21771123 ↗
• MalfunctionApr 4, 2025Product Quality Problem; Material Split, Cut or Torn; Product Quality Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, A FILM WAS DISCOVERED ON THE MEMBRANE OF THE TROCAR, THE SEAL WAS DAMAGED. IT WAS NOTED THAT SIX TROCARS WAS USED AND HAD THE SAME ISSUE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21770888 ↗
• MalfunctionApr 4, 2025Product Quality Problem; Material Split, Cut or Torn; Product Quality Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, A FILM WAS DISCOVERED ON THE MEMBRANE OF THE TROCAR, THE SEAL WAS DAMAGED. IT WAS NOTED THAT SIX TROCARS WAS USED AND HAD THE SAME ISSUE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21770866 ↗
• MalfunctionApr 4, 2025Product Quality Problem; Material Split, Cut or Torn; Product Quality Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, A FILM WAS DISCOVERED ON THE MEMBRANE OF THE TROCAR. IT WAS NOTED THAT FOUR TROCAR HAD THE SAME ISSUE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21770848 ↗
• InjuryApr 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RIGHT INGUINAL HERNIA REPAIR, THE TIP OF A 5 MM LAPAROSCOPIC TROCAR WAS FOUND TO BE NOT INTACT, WITH A SMALL PIECE MISSING. THE DEVICE COMPONENT, SPECIFICALLY THE TIP OF THE CANNULA, FELL INTO THE CAVITY OF THE PATIENT. SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM. AN EXTENSIVE SEARCH WITHIN THE SURGICAL AREA WAS CONDUCTED TO LOCATE THE MISSING PIECE, AND AN X-RAY WAS ATTEMPTED TO LOCATE THE MISSING PART BUT DID NOT YIELD ANY RESULTS. THE WOUND WAS CLOSED, DRESSING WAS DONE, THE PATIENT WAS EXTUBATED AND SHIFTED TO RECOVERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21736783 ↗
• MalfunctionMay 17, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC GASTRIC BYPASS, WHEN INSERTING THE TROCARS THROUGH THE ABDOMINAL WALL, THE SEALS OF THREE TROCARS WERE BROKEN. CARBON DIOXIDE (CO2) LEAKED. ALL THREE TROCARS WERE REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19343537 ↗
• MalfunctionMar 5, 2024Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THERE WERE AUDIBLY AIR/GAS LEAKS FOR THE 5MM. AND 12MM. TROCARS. IT WAS ALSO MENTIONED THAT THE SEAL DISENGAGED FOR BOTH TROCARS.

  Patient problems: Insufficient Information

  MAUDE report 18837516 ↗
• MalfunctionMar 1, 2024Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC ROUX EN Y GASTRIC BYPASS, ABOUT HALFWAY THROUGH THE PROCEDURE,  THE SURGEON'S LEFT HAND 12MM. PORT BEGAN TO AUDIBLY LEAK CO2 WHILE AN INSTRUMENT WAS INSERTED INTO THE PORT. THE LEAK STARTED AFTER MULTIPLE INSTRUMENT EXCHANGES FROM 5MM TO 12MM SHAFTED DEVICES. THE CO2 LEAK WAS EXACERBATED WHEN TORQUE WAS PUT ON THE PORT SITE, BUT STILL PRESENT WITHOUT TORQUE. IT WAS NOTED THAT THE SEAL DISENGAGED FOR BOTH TROCARS, FOR THE 12MM IT WAS THE UPPER DISC VALVE AND FOR THE 5MM IT WAS THE LOWER VALVE. SHORTLY THE 5MM ASSIST PORT BEGAN TO LEAK WHEN THERE WAS NO INSTRUMENT PLACED INSIDE THE TROCAR WHICH WAS LIKELY CAUSED BY DEBRIS BEING LODGE IN THE VALUE. IT WAS IDENTIFIED THAT THE ROUTE OF THE PROBLEM WAS THE DISK VALVE, SO THE TROCAR CAP WAS REPLACED BY A NEW 12MM TROCAR CAP, AND THE LEAK CEASED. NO DEVICE COMPONENT FELL INTO THE CAVITY OF THE PATIENT. THERE WAS NO P ATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18820345 ↗
• MalfunctionFeb 7, 2024Leak/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 CHOLECYSTECTOMY, THE MEMBRANE WAS RUPTURED AND WAS LEAKING. IT WAS ALSO NOTED THAT THE SEAL DISENGAGED WHILE INTRODUCING THE CLIP APPLIER. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18663076 ↗
• MalfunctionJan 30, 2024Leak/Splash; Detachment of Device or Device Component; Insufficient Device Problem Information; Material Split, Cut or Torn; Leak/Splash; Detachment of Device or Device Component; Insufficient Device Problem Information; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC GASTRIC BYPASS, THREE TROCARS HAVE FAILED TO FILTER CO2. THE SEALS WERE DAMAGED AND DISENGAGED. THE DEVICES LEAK AIR OR GAS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18604023 ↗
• MalfunctionJan 30, 2024Leak/Splash; Detachment of Device or Device Component; Insufficient Device Problem Information; Material Split, Cut or Torn; Leak/Splash; Detachment of Device or Device Component; Insufficient Device Problem Information; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC GASTRIC BYPASS, THE TROCARS HAVE FAILED TO FILTER CO2. THE SEALS WERE DAMAGED AND DISENGAGED. THE DEVICES LEAK AIR OR GAS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18604011 ↗
• MalfunctionJan 5, 2024Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE, THE TIP OF THE TROCAR HAD ARRIVED BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18459074 ↗
• InjuryDec 8, 2022Break; Detachment of Device or Device Component; Material Split, Cut or Torn; Break; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDICECTOMY, WHEN THE SURGEON PUT THE TROCAR INSIDE THE PATIENT, A PIECE OF THE TROCAR HAS DISINTEGRATED IN THE PATIENT CAVITY AND THE SEAL WAS DAMAGED. LEAVING BLUE PARTICLES IN THE STOMACH AND A LESION OF AN ARTERIOLE FOLLOWING THE BLUNTING OF THE TROCAR. THE BLUE PARTICLES WERE RETRIEVED USING A LAPAROSCOPIC GRASPING FORCEPS. THE SURGEON STOPPED A LITTLE BLEEDING BY USING A LAPAROSCOPIC BIPOLAR AND USED A NEW TROCAR TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15942378 ↗
• MalfunctionApr 27, 2022Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, PREOPERATIVELY, 2 TROCARS BROKE. WHEN THE NURSE TOOK UP THE TROCAR, BOTH WHERE OILY. NEW TROCARS WERE USED TO CONTINUE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14220191 ↗
• MalfunctionMar 31, 2020Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THERE WAS A DAMAGED SEAL ON ALL PORTS AND A FOREIGN SUBSTANCE IN THE PACKAGE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9902298 ↗
• MalfunctionFeb 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PARTIAL COLECTOMY, A PLASTIC FRAGMENT OF ABOUT 5 X 2 MM WAS FOUND. THE PRODUCTS WERE DISASSEMBLED AND CHECKED AFTER THE PROCEDURE COMPLETED, BUT WHERE THE FRAGMENT FELL FROM COULD NOT BE IDENTIFIED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9660037 ↗
• MalfunctionJun 24, 2019Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE TROCAR WAS INSERTED INTO THE ABDOMEN, THE PROBLEM IS THAT THE INSTRUMENTS WERE STOCKING INTO THE TROCAR ALL THE TIME. IT WAS A BIT TRICKY TO INSERT AND PULL THEM WITHOUT STOCKING. THE SMOOTH PASSAGE WAS MISSING. USE ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8726783 ↗
• MalfunctionJun 20, 2019Difficult to Remove; Detachment of Device or Device Component; Human-Device Interface Problem; Difficult to Remove; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN THE SUCTION WAS PULL OUT, IT WAS STUCK IN THE SEAL SO EVERYTHING HAD TO BE REMOVED. THE SEAL DISENGAGED AND THERE WAS NO GAS IS COMING OFT OF THE PNEUMOPERITONEUM. TO COMPLETE THE PROCEDURE, TOOK OUT THE TROCAR AND GOT A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8717494 ↗
• MalfunctionMar 11, 2019Leak/Splash; Packaging Problem; Leak/Splash; Packaging Problem

  ACCORDING TO THE REPORTER, DURING TROCAR INSERTION ON A LAPAROSCOPIC BARIATRIC, AIR OR GAS LEAKED FROM THE SEAL. IT WAS STATED THAT THE SEAL WAS DAMAGED. IT WAS ALSO STATED THAT THERE WAS A NOTICEABLE LOSS OF ABDOMINAL PRESSURE. THEY OPENED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8407963 ↗
• MalfunctionMar 6, 2019Difficult to Insert; Packaging Problem; Difficult to Insert; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A SLEEVE PROCEDURE, WHILE INSERTING INSTRUMENT THROUGH PORTS, INSTRUMENTS WERE STICKING ON THE TWO 5MM TROCARS THAT LED TO BREAKAGE THE SEALS OF THE TWO 5MM TROCARS. THERE WAS ALSO A LEAK ON THE 15MM TROCAR. WHILE SUTURING, THE SURGEON EXPERIENCED DIFFICULTY IN LOADING, TOGGLING AND UNLOADING THE SUTURING DEVICE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8395434 ↗