VersaOne RSEALRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10884521785816), received between May 20, 2021 and Feb 10, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (8 reports).

3 other recalls cover devices cleared under the same FDA submission (K201805); they may or may not involve this specific model.

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Break

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC PROXIMAL GASTRECTOMY SURGERY WITH ROBOT SUPPORT, WHILE ON DOCKING, TO CHANGE THE DIRECTION OF THE SMOKE EXHAUST TUBE, THE TROCAR WAS ROTATED, HOWEVER, DURING THAT TIME, THE PORT PART WAS DAMAGED. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310260 ↗
• MalfunctionDec 26, 2025Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC TOTAL GASTRECTOMY WITH ROBOT SUPPORT, WHEN ON LYMPH NODE RESECTION, THE TROCAR CAME INTO CONTACT WITH THE ADJACENT PORT. DURING THIS CONTACT, THE INSUFFLATION PORT BROKE OFF, CAUSING A PNEUMOPERITONEUM LEAK. THE DEVICE WAS REPLACED WITH A NEW SEAL TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23900707 ↗
• MalfunctionDec 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC SURGERY WITH ROBOT SUPPORT RADICAL PROSTATECTOMY, AFTER DOCKING WITH THE ROBOTIC ARM, THE INSUFFLATION PORT WAS FACING THE PATIENT'S ABDOMEN, AND A CRACKING SOUND WAS HEARD DURING THE ROTATION MANEUVER TO REPOSITION IT. ALTHOUGH THERE WERE NO MAJOR VISIBLE PROBLEMS, A PNEUMOPERITONEUM LEAK OCCURRED. THE SEAL OF THE TROCAR WAS DAMAGED. A NEW SEAL WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866091 ↗
• MalfunctionDec 11, 2025Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY WITH ROBOT SUPPORT, IN PERIUTERINE TISSUE TREATMENT, THE PNEUMOPERITONEUM DEVICE SHOWED A LOW VALUE. WHEN IT WAS CHECKED, THE SEAL'S EARLY PORT WAS DAMAGED, HAD COME OFF, AND WAS LEAKING AIR. NO COMPONENTS FELL INTO THE PATIENT'S ABDOMINAL CAVITY. TO RESOLVE THE ISSUE, THE DEVICE WAS REPLACED WITH A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23785580 ↗
• MalfunctionJul 25, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, AT THE START OF A ROBOTIC LAPAROSCOPIC RADICAL PROSTATECTOMY WHILE THE PATIENT WAS ON THE TABLE, UNDER ANESTHESIA, WITH THE TROCAR PLACED, THE ARM DOCKED, AND THE INSTRUMENT INSERTED, THE SINGLE USE VERSAONE "RSEAL" SEAL, BLOCKED THE INSTRUMENT'S INSERTION THROUGH THE PORT. THE BLUE INTERNAL LIPS OF THE SEAL WERE BLOCKING THE WAY FOR THE INSTRUMENT. A LAPAROSCOPIC INSTRUMENT WITH A SMALLER DIAMETER WAS INSERTED WITH NO ISSUE. THE SEAL WAS EXCHANGED AND THIS SOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 22613511 ↗
• MalfunctionJun 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC WITH ROBOT SUPPORT RADICAL PROSTATECTOMY, WHILE INSERTING A FORCEPS, IT WAS INSERTED WITH THE OUTER SIDE OF THE SEAL MATERIAL ATTACHED. IT WAS FOUND INSIDE THE BODY AS IS AND WAS TAKEN OUT BY LAPAROSCOPIC FORCEPS AND REPLACED WITH A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22360124 ↗
• MalfunctionFeb 10, 2025Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A RADICAL PROSTATECTOMY USING THE HUGO ROBOTIC ASSISTED SURGERY SYSTEM, THERE WAS AN INABILITY TO INSERT INSTRUMENTS THROUGH THE SEAL. BOTH INSTRUMENTS DID NOT ENTER DEEP ENOUGH TO CALIBRATE, AND THE SEAL WAS IDENTIFIED AS FAULTY FROM THE BEGINNING. THE ISSUE RESULTED IN A LOSS OF 5 TO 10 MINUTES DURING THE PROCEDURE. THE PATIENT WAS UNDER ANESTHESIA, AND THE ASSISTANT ATTEMPTED TO INSERT THE SHEARS THROUGH THE TROCARS WITHOUT SUCCESS. THERE WERE NO ALARMS, AND THE INSTRUMENT WAS RECOGNIZED. TROUBLESHOOTING STEPS INCLUDED UNDOCKING AND REDOCKING, AND ATTEMPTING TO INSERT A SMALLER DIAMETER LAPAROSCOPIC INSTRUMENT, WHICH WAS SUCCESSFUL. A RECOMMENDATION TO CHANGE THE SEAL RESOLVED THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344374 ↗
• MalfunctionDec 30, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IN A ROBOTIC LAPAROSCOPIC SIGMOIDECTOMY, WHILE MOBILIZING THE TISSUE TO REACH THE TARGET, TWO TROCARS WERE DAMAGED. THE SURGEON OBSERVED SOME BLUE OR PURPLE LINES ON THE SIDES OF THE INSTRUMENT JAW TIP. WHEN THE INSTRUMENT WAS REMOVED FROM THE PATIENT¿S BODY, THE LINE DISAPPEARED, BUT APPEARED AGAIN WHEN INSERTED INTO THE BODY. THE CUSTOMER SUSPECTED THAT THERE WERE MATERIAL TEAR FROM THE TWO TROCAR VALVES. ANOTHER DEVICE FROM SAME LOT NUMBER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21034827 ↗
• MalfunctionDec 30, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IN A ROBOTIC LAPAROSCOPIC SIGMOIDECTOMY, WHILE MOBILIZING THE TISSUE TO REACH THE TARGET, TWO TROCARS WERE DAMAGED. THE SURGEON OBSERVED SOME BLUE OR PURPLE LINES ON THE SIDES OF THE INSTRUMENT JAW TIP. WHEN THE INSTRUMENT WAS REMOVED FROM THE PATIENT¿S BODY, THE LINE DISAPPEARED, BUT APPEARED AGAIN WHEN INSERTED INTO THE BODY. THE CUSTOMER SUSPECTED THAT THERE WERE MATERIAL TEAR FROM THE TWO TROCAR VALVES. ANOTHER DEVICE FROM SAME LOT NUMBER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21034816 ↗
• MalfunctionDec 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING ROBOTIC LAPAROSCOPIC PROSTATECTOMY PROCEDURE, THERE WAS A DAMAGED SEAL ON THE TROCAR. PLASTIC RESIDUE FROM RSEAL WAS RETRIEVED WITH GRASPERS THROUGH ASSISTANT PORT. THERE WAS A TOTAL OF 10 MINUTES OF DELAY OF PROCEDURE DUE TO THE REPORTED EVENT. THERE WAS NO INJURY REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20898547 ↗
• MalfunctionFeb 22, 2022Break; Break

  ACCORDING TO THE REPORTER, FOLLOWING LAB EVALUATION, IT WAS NOTED THAT RELEASE TAB OF THE PLASTIC PORT SEAL THAT IS INSERTED INTO THE METAL PORT WAS CRACKED HALFWAY. 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 13582555 ↗
• MalfunctionFeb 7, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, FOLLOWING LABORATORY EVALUATION, IT WAS NOTED THAT THE STOPCOCK OF THE SEAL ON THE PORT WAS ALMOST COMPLETELY BROKEN OFF. THERE WAS NO DAMAGE OBSERVED AT THE BEGINNING OF THE EVALUATION WHEN THE PACKAGING OF THE PORT WAS FIRST OPENED. IT WAS NOTED THE DAMAGE WAS ONLY NOTICED IN THE POST-PROCEDURAL CHECKS AND THE DID NOT CAUSE ANY ISSUES DURING THE PROCEDURE, NOTHING WAS NEEDED TO RESOLVE TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13471674 ↗
• MalfunctionJan 3, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, FOLLOWING LABORATORY EVALUATION, IT WAS NOTED THAT THE SEAL OF THE METAL PORT HAD A SLIGHT TEAR IN IT. 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 13142471 ↗
• MalfunctionJan 3, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, FOLLOWING A CADAVERIC LABORATORY EVALUATION, IT WAS NOTED THAT THE SEAL OF THE METAL PORT HAD A SLIGHT TEAR IN IT. 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 13142447 ↗
• MalfunctionJul 13, 2021Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, FOLLOWING LAB EVALUATION, THE SEAL USED WITH THE METAL PORT HAD A SLIGHT TEAR. THERE WAS NO DAMAGE OBSERVED AT THE BEGINNING OF THE EVALUATION WHEN THE PACKAGING OF THE TWO PORTS WAS FIRST OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12164285 ↗
• MalfunctionJun 20, 2021Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, FOLLOWING LAB EVALUATION, THE SEAL USED WITH THE METAL PORT HAD A SLIGHT TEAR. THERE WAS NO DAMAGE OBSERVED AT THE BEGINNING OF THE EVALUATION WHEN THE PACKAGING OF THE TWO PORTS WAS FIRST OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12030510 ↗
• MalfunctionJun 18, 2021Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, FOLLOWING LABORATORY EVALUATION, THE SEAL USED WITH THE METAL PORT HAD A SLIGHT TEAR. THERE WAS NO DAMAGE OBSERVED AT THE BEGINNING OF THE EVALUATION WHEN THE PACKAGING OF THE TWO PORTS WAS FIRST OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12024271 ↗
• MalfunctionJun 16, 2021Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, FOLLOWING LAB EVALUATION, THE SEAL USED WITH THE METAL PORT HAD A SLIGHT TEAR. THERE WAS NO DAMAGE OBSERVED AT THE BEGINNING OF THE EVALUATION WHEN THE PACKAGING OF THE TWO PORTS WAS FIRST OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12012466 ↗
• MalfunctionMay 20, 2021Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, FOLLOWING LAB EVALUATION, A SLIGHT TEAR WAS FOUND AT THE PROXIMAL SEAL 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 11858085 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201805. One submission often covers many models, so check the product and lot details in each record.

• Z-1463-2023 · Mar 22, 2023 · Open, Classified
  VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
• Z-1464-2023 · Mar 22, 2023 · Open, Classified
  VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
• Z-1465-2023 · Mar 22, 2023 · Open, Classified
  VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS