VersaOne RONB11STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521717688), received between Dec 7, 2021 and Dec 17, 2025 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  ACCORDING TO THE REPORTER, DURING CLINICAL, DURING UTEROLYSIS WITH EXCISION OF ENDOMETRIOSIS WHEN THE PORT WAS PLACED ON THE 11MM ADAPTER, IT RESULTED IN A RAPID LOSS OF PNEUMOPERITONEUM AND INABILITY TO MAINTAIN THE IT. THE SURGEON TRIED MULTIPLE TECHNIQUES FOR TROUBLE SHOOTING INCLUDING CHANGING INSUFFLATION EQUIPMENT TO AIR SEAL (WHICH PROVIDES MORE RAPID REPLACEMENT OF PNEUMOPERITONEUM TO MATCH LOSSES), WRAPPING THE TROCAR WITH GAUZE TO IMPROVE THE FIT BETWEEN ADAPTER DESIGNED FOR 12 MM STANDARD TROCAR AND THE 11 MM ROBOTIC TROCAR BUT IT MOVED THROUGH THE GAS QUICKLY. THE 11MM TROCAR BEING INCOMPATIBLE WITHOUT ADJUSTMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23831899 ↗
• InjuryNov 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A TOTAL PROSTATECTOMY WITH ROBOT SUPPORT, WHEN THE CAMERA ARM WAS UNDOCKED AT THE END OF OPERATION, THE SEAL WAS BROKEN WHEN THE ARM WAS RAISED IN A DOCKED STATE AFTER THE CAMERA WAS REMOVED. IT WAS NOTED THAT THE DAMAGED PART WAS COLLECTED, NO PIECES WERE DROPPED IN THE BODY CAVITY, AND AN X-RAY WAS PERFORMED FOR SEARCHING AND CONFIRMING THE REMNANT. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 20619797 ↗
• MalfunctionJul 7, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC TRANS OBTURATOR TAPE REMOVAL AND FIX OF FASCIA LATA SLING, THERE WERE MULTIPLE ISSUES. FIRST, DURING DOCKING, THE ROBOTIC TROCAR WAS BURPED TO CREATE SOME SPACE INSIDE THE CAVITY AND THE HEAD OF THE TROCAR BROKE AND WAS REPLACED WITH A NEW ONE. LATER, DURING THE CUTTING OF TISSUES, THE SURGEON MADE A FAST CUTTING MOVEMENT WITH THE MONOPOLAR CURVED SHEARS (MCS) AND AN ERROR OCCURRED. THE MCS WAS REMOVED BY THE SCRUB NURSE FOLLOWING THE OFFICIAL MEDTRONIC BROKEN INSTRUMENT QUICK REFERENCE GUIDE. THE INSTRUMENT WAS REPLACED WITH A NEW ONE. WHILE THE INSTRUMENT WAS REMOVED, AN ERROR OCCURRED ON ARM CART ASSEMBLY (ACA) #2. THE ACA WAS RESTARTED BECAUSE IT WAS NOT RESPONDING. AFTER THE RESTART AND SUCCESSFUL CALIBRATION, THE NEW MCS WAS ATTACHED. DURING THE COAGULATION OF THE TISSUE, THE BIPOLAR FENESTRATED GRASPER (BFG) CABLE BROKE WITH A PULLEY DEVICE FALLING INTO THE CAVITY. THE BFG WAS REMOVED BY THE SCRUB NURSE FOLLOWING THE OFFICIAL MEDTRONIC BROKEN INSTRUMENT QUICK REFERENCE GUIDE. THE INSTRUMENT WAS REPLACED WITH A NEW ONE. WHILE THE INSTRUMENT WAS REMOVED, AN ERROR OCCURRED ON ARM CART ASSEMBLY (ACA) #1. THE ACA WAS RESTAR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19686842 ↗
• MalfunctionJun 12, 2024Difficult to Insert; Product Quality Problem; Difficult to Insert; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC SLEEVE PROCEDURE, WHEN THE SURGEON PERFORMED BARIATRIC SURGERY ON AN OBESE PATIENT, IT WAS NECESSARY TO USE LONGER TROCARS. SINCE THE STANDARD TROCAR HAD TO BE INTRODUCED ENTIRELY TO REACH THE ABDOMINAL CAVITY, IT BECAME IMPOSSIBLE TO MOVE OR ADJUST THE TWO TROCARS WITHOUT EXERTING SIGNIFICANT FORCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19524399 ↗
• InjuryMay 23, 2024Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A LAPAROSCOPIC BYPASS WAS GOING TO BE PERFORMED WITH THE ROBOT. AT THE TIME OF PLACING THE ROBOTIC TROCARS, THE SURGEON REALIZED THAT THE TROCARS HAD TO BE FULLY INSERTED TO REACH THE ABDOMINAL CAVITY, WHICH MEANT THAT THE TROCAR HAD NO MOBILITY. THE TROCAR WAS NOT LONG ENOUGH TO PERFORM A ROBOTIC BARIATRIC SURGERY. FOR THIS REASON, THE SURGEON DECIDED TO CONVERT THE SURGERY TO LAPAROSCOPY. IN THE END, THE SURGERY HAS NOT BEEN CONVERTED TO LAPAROSCOPY EITHER BECAUSE THE PATIENT DECOMPENSATED, THUS SUSPENDING THE SURGERY. THE DECOMPENSATION WAS NOT RELATED TO THE DEVICE AND WAS RELATED TO THE ANESTHESIA.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19385844 ↗
• InjuryFeb 29, 2024Difficult to Insert; Product Quality Problem; Difficult to Insert; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROSTHETIC DEVICE EXTRACTION, THE STANDARD TROCAR APPEARED TO BE TOO SHORT FOR THE PATIENT. SWITCHING INSTRUMENTS WAS VERY DIFFICULT, AND THE LOSS OF POSITIONING OF THE TROCARS THROUGH THE WALL WAS RECURRENT AND RISKY. THIS IS DUE TO THE FACT THAT THE PATIENT HAD A HIGH BODY MASS INDEX (BMI), A PNEUMOPERITONEUM, AND TRENDELENBURG LIMITATIONS. THE PATIENT ALSO HAD A VERY THICK ABDOMINAL WALL WITH A LOT OF FAT LAYERS INSIDE THE ABDOMINAL WALL. THE SURGEON CONVERTED TO OPEN SURGERY FOR PATIENT SAFETY AND DUE TO THE DELAY GENERATED BY THE LIMITATIONS OF THE TROCARS, IN WHICH THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE. AN INCISION OF MORE THAN ONE INCH WAS MADE IN THE PUBIC AREA TO ACCESS THE TARGET ANATOMY. THE PATIENT HAD FIVE MORE DAYS POST-OP SURGERY AND HAD AN INFECTION RESULTING FROM THE LAPAROTOMY. MOREOVER, THE PATIENT EXTENDED HOSPITALIZATION FOR SEVEN DAYS MORE, AND AN ADDITIONAL OPERATION WILL BE PERFORMED TO CORRECT THE ISSUE. IT WAS NOTED THAT THE PATIENT WAS HOSPITALIZED FOR AN ABSCESS ON THE SCAR, INFECTION AND LACK OF HEALING OF THE BLADDER.

  Patient problems: Laceration(s); Unspecified Infection

  MAUDE report 18809066 ↗
• MalfunctionMar 24, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, THE EVENT OCCURRED DURING ROBOTIC PROSTATECTOMY PROCEDURE. PRIOR TO SURGERY, THERE WAS AN ISSUE WITH THE TROCAR. THE TROCAR WAS BENT AND HAD DAMAGED TIP. THE OBTURATOR WAS DAMAGED AND COULD NOT PASS THROUGH THE TROCAR, AND TROCAR¿S EDGE WAS CHIPPED. TROCAR WAS REPLACED PRIOR SURGERY THERE WAS A 5 MINUTE DELAY. DURING SEMINAL VESICLES DISSECTION, THE BIPOLAR MARYLAND FORCEPS (BMF) JAWS MISALIGNED PREVENTING PROPER FUNCTION TO MANAGE THE TISSUE. ENERGY DELIVERY REMAINED WORKING. THE BMF WAS REPLACED. THERE WAS A 5 MINUTE DELAY TO PROCEDURE. THERE WAS ALSO A TORN TIP COVER DURING NORMAL USE. THE TIP COVER WAS REPLACED. THERE WAS NO INJURY TO THE PATIENT. THERE WAS A TOTAL OF LESS THAN 10 MINUTE DELAY TO PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16615175 ↗
• MalfunctionFeb 8, 2023Entrapment of Device; Entrapment of Device

  ACCORDING TO THE CLINICAL STUDY, 6 DAYS POST-OPERATIVE OF A RADICAL PROSTATECTOMY, THE PATIENT HAD NAUSEA, VOMITING, ABDOMINAL PAIN, HEMATURIA, NO STOOLS, AND SCANTY FLATUS. ABDOMINAL COMPUTED TOMOGRAPHY (CT) SCAN SHOWED ILEUS OF THE SMALL INTESTINE. DIAGNOSTIC LAPAROSCOPY WHICH WAS DONE DUE TO THE COMPUTED TOMOGRAPHY (CT) SCAN, ALSO SHOWED ILEUS. THE PATIENT WAS TREATED WITH SURGERY AS INTERVENTION FOR THE ILEUS. THE PATIENT WAS FURTHER GIVEN INTRAVENOUS ANTIBIOTICS DUE TO HIGH INFECTION RATES CAUSED BY THE ILEUS. THE ADVERSE EVENTS ARE CAUSALLY RELATED TO THE STUDY PROCEDURE AND ARE NOT RELATED TO THE DEVICES. CONCURRENTLY, WITH THE COMPUTED TOMOGRAPHY (CT) SCAN AND REOPERATION, THE BOWEL WAS CONFIRMED TO HAVE BEEN STUCK TO THE SURGICAL PORT.

  Patient problems: Insufficient Information

  MAUDE report 16330314 ↗
• MalfunctionJan 3, 2022Break; Break

  ACCORDING TO THE REPORTER, FOLLOWING LAB EVALUATION, DAMAGED WAS NOTED TO THE DISTAL END OF THE PORT. THERE WAS NO DAMAGE OBSERVED AT THE BEGINNING OF THE EVALUATION WHEN THE PACKAGING OF THE PORT WAS FIRST OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142411 ↗
• MalfunctionDec 29, 2021Break; Break

  ACCORDING TO THE REPORTER, FOLLOWING LAB EVALUATION, IT WAS NOTED THAT THE DISTAL TIP OF A PORT HAD TWO INDENTATIONS. THERE WAS NO DAMAGE OBSERVED AT THE BEGINNING OF THE EVALUATION WHEN THE PACKAGING OF THE PORT WAS FIRST OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112435 ↗
• MalfunctionDec 7, 2021Break; Difficult to Insert; Detachment of Device or Device Component; Break; Difficult to Insert; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, FOLLOWING LAB EVALUATION, WHEN ATTEMPTING TO INSERT AN ENDOSCOPE INTO THE PORT, DID NOT GUIDE THE ENDOSCOPE DIRECTLY INTO THE PORT HOLE. THE ENDOSCOPE HIT THE PORT CAP, AND THE PORT CAP DETACHED FROM THE PORT. BOTH THE PORT AND PORT CAP HAD PIECES CHIPPED OFF. THERE WAS NO DAMAGE OBSERVED AT THE BEGINNING OF THE EVALUATION WHEN THE PACKAGING OF THE PORT WAS FIRST OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12954458 ↗