VersaOne ONB12STFCSRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10884521678712), received between Jun 21, 2019 and Oct 9, 2024 — classified as 2 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (9 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC PROCEDURE, THE PRODUCT DID NOT WORK. THE SEAL WAS DAMAGED. THE DEVICE WAS REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20405187 ↗
• MalfunctionJul 24, 2024Device Contamination with Chemical or Other Material; Material Protrusion/Extrusion; Device Contamination with Chemical or Other Material; Material Protrusion/Extrusion

  ACCORDING TO THE REPORTER, PREOPERATIVELY, BEFORE OPENING THE PACKAGE, THERE WAS FOREIGN OBJECT (BURR) CONTAMINATION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818099 ↗
• MalfunctionJan 11, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, AT THE TIME OF MAKING HOLES IN THE TISSUE, THE DEVICE BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18495770 ↗
• MalfunctionNov 22, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOID COLON RESECTION, AT THE START OF THE PROCEDURE, THE TROCAR HAD AN PNEUMOPER ITONEUM LEAK. THE SEAL WAS DAMAGED. ANOTHER TROCAR WAS USED TO CONTINUE THE CASE. MEANWHILE, WHEN CLIPPING THE BLOOD VESSEL, THE HANDLE WAS HARD TO SQUEEZE. UPON A STRONG SQUEEZE, THE TIP OF THE CLIP CLOSED A LITTLE, AND THE DEVICE COULD NOT BE USED. NO CLIP WAS ABLE TO LOAD PROPERLY. ANOTHER CLIP APPLIER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18196182 ↗
• MalfunctionOct 27, 2023Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRECTOMY, IMMEDIATELY AFTER THE START OF THE SURGERY, THE CARBON DIOXIDE LEAKED FROM THE SIDE WINDOW OR THE PART WHERE THE FORCEPS WERE INSERTED AND REMOVED. THE PNEUMOPERITONEUM PRESSURE DID NOT INCREASE TO THE SET VALUE AND CAUSED RAPID LOSS OF PNEUMOPERITONEUM. THESE HAPPENED ON THE TWO TROCARS. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18024661 ↗
• MalfunctionOct 24, 2023Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRECTOMY, IMMEDIATELY AFTER THE START OF THE SURGERY, THE CARBON DIOXIDE LEAKED FROM THE SIDE WINDOW OR THE PART WHERE THE FORCEPS WERE INSERTED AND REMOVED. THE PNEUMOPERITONEUM PRESSURE DID NOT INCREASE TO THE SET VALUE AND CAUSED RAPID LOSS OF PNEUMOPERITONEUM. THESE HAPPENED ON THE TWO TROCARS. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994863 ↗
• MalfunctionMar 7, 2023Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC GASTRECTOMY, THE INNER CYLINDER OF THE PRODUCT DID NOT COME OFF FROM THE OUTER CYLINDER. THE DEFECTIVE PRODUCT WAS REPLACED WITH ANOTHER PRODUCT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16494668 ↗
• MalfunctionNov 21, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RESECTION, ABOUT 20 MINUTES AFTER THE START, THE SEAL WAS DAMAGED OR THE PNEUMOPERITONEUM STARTED LEAKING. THE SURGEON COMMENTED THAT THERE WERE NOT MANY INSERTIONS AND WITHDRAWALS OF THE ENERGY 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 15835674 ↗
• MalfunctionOct 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LEFT COLORECTAL RESECTION, THE TIP OF THE CLIP APPLIER WAS CAUGHT ON THE THE UPPER SEAL OF THE TROCAR. THIS CAUSED THE UPPER SEAL TO COME OFF. 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 15523080 ↗
• MalfunctionAug 22, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN INSERTING HOOK DIATHERMY, THE SEAL OF PORT WAS BROKEN. THE PORT STARTED TO LEAK GAS AND INSUFFLATION AFFECTED. ANOTHER COMPETITOR PORT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15271695 ↗
• MalfunctionJun 23, 2022Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, PRIOR TO GASTRIC BYPASS, THE DEVICE PUNCH DOES NOT FIT INTO CANNULA. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14788319 ↗
• MalfunctionMay 6, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, AFTER A PROCEDURE, THERE WAS A HOUSING SEAL TEAR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14307138 ↗
• MalfunctionMay 6, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE HOUSING OF THE SEAL WAS TORN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14306747 ↗
• MalfunctionJan 11, 2022Difficult to Insert; Device Difficult to Setup or Prepare; Difficult to Insert; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE TESTING THE DEVICE BEFORE USING IT ON THE PATIENT, THE SURGEON WAS UNABLE TO INSERT INSTRUMENTS INTO THE TROCAR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13225884 ↗
• MalfunctionJan 4, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ANTERIOR RESECTION, WHILE TRANSACTING RECTUM AND THE STAPLER WAS INSERTED, THE CANNULA BROKE. THE COMPONENT DISENGAGED INTO PATIENT CAVITY. THE BROKEN PARTS WERE FOUND IN THE ABDOMEN AND RETRIEVED USING LAPAROSCOPIC GRASPERS. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13153559 ↗
• MalfunctionJan 4, 2022Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INTESTINUM CRASSUM PROCEDURE, THE TROCAR WAS WORKING WELL AT THE BEGINNING, BUT THE SEAL PART MAY HAVE MISALIGNED AND DAMAGED IN THE MIDDLE OF THE PROCEDURE, AND THE CAMERA COULD NOT BE INSERTED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13153221 ↗
• MalfunctionDec 8, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE SEAL WAS BROKEN AT THE ENTRANCE OF THE TROCAR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12962408 ↗
• MalfunctionOct 20, 2021Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, ON LAPAROSCOPIC ABDOMINAL INCISIONAL HERNIA REPAIR, DURING WOUND CLOSURE, THERE WAS PNEUMOPERITONEUM LEAKAGE. THERE WAS SEAL DAMAGE AND AIR OR GAS LEAKED FROM THE SEAL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12669212 ↗
• MalfunctionMay 25, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SUTURE PASSER DID NOT PASS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11875876 ↗
• MalfunctionMay 25, 2021Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE SUTURE PASSER WAS NOT ABLE TO PASS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11875790 ↗
• InjuryMar 1, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A CLOSURE TROCAR WAS USED FOR INCISIONAL WOUND CLOSURE OF THE 12 MM TROCAR DURING ABDOMINAL INCISIONAL HERNIA, THERE WAS AIR OR GAS LEAKAGE FROM THE SEAL, 4 DAYS AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PATIENT WENT THROUGH AN EMERGENCY TREATMENT DUE TO ABDOMINAL PAIN. THE FASCIA WAS FOUND NOT PROPERLY PICKED UP BY THE THREAD OF THE CLOSURE TROCAR, WHICH HAD BEEN PLACED WITH THE HERNIA FROM THE 12MM PORT WOUND. A 5 CM INCISION WAS MADE AS AN EMERGENCY PROCEDURE, AND THE FASCIA WAS CLOSED UNDER DIRECT VISION.

  Patient problems: Abdominal Pain; Unspecified Tissue Injury

  MAUDE report 11395612 ↗
• MalfunctionJan 25, 2021Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SUTURE PASSER DID NOT PASS. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11222465 ↗
• MalfunctionDec 1, 2020Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC STOMACH SURGERY, WHEN CLOSING WOUND FROM PORT INCISION, PART OF THE WINDOW FELL INTO THE CAVITY AND WAS RETRIEVED BY USING FORCEPS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10926500 ↗
• MalfunctionOct 27, 2020Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC COLECTOMY, AFTER THE RECONSTRUCTION WAS COMPLETED, IT WAS DISCOVERED THAT ONE OF THE WINDOWS OF THE DEVICE DROPPED INTO THE CAVITY AFTER THE PNEUMOPERITONEUM. THE FALLEN PIECE WAS RETRIEVED WITH FORCEPS THROUGH THE TROCAR. THE SEAL WAS ALSO MISALIGNED, AND THE CANNULA BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10739293 ↗
• MalfunctionAug 24, 2020Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HEPATECTOMY, WHILE USING THE INSTRUMENT, THE ACTIVE BLADE WAS FOUND TO BE ADHERED WITH A BLUE MATERIAL AND IT WAS COLLECTED. IT WAS THE BLUE SEAL PART NEAR THE FORCEPS INSERTION PORT OF THE HEAD PART. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10440901 ↗