Versaport UNVCA12STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 373 adverse event reports that list this exact device (DI 10884521215399), received between Apr 4, 2017 and Aug 31, 2026 — classified as 9 injuries, 364 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (216 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 373 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Leak/Splash; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50516411 ↗
• MalfunctionAug 31, 2026Leak/Splash; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50516390 ↗
• MalfunctionAug 4, 2026Material Split, Cut or Torn

  It was reported that during a laparoscopic procedure, the seal was damaged on twelve cannulas. To resolve the issue and complete the case, the cannula was removed. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50129090 ↗
• MalfunctionAug 4, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50129046 ↗
• MalfunctionAug 4, 2026Material Split, Cut or Torn

  It was reported that during a laparoscopic procedure, the seal was damaged on twelve cannulas. To resolve the issue and complete the case, the cannula was removed. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50128987 ↗
• MalfunctionAug 4, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50128763 ↗
• MalfunctionAug 4, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50128730 ↗
• MalfunctionAug 4, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50128650 ↗
• MalfunctionAug 4, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50128521 ↗
• MalfunctionJul 31, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50107764 ↗
• MalfunctionMay 19, 2026Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, A GAS WAS OBSERVED ESCAPING THROUGH THE TROCAR VALVE AT THE START OF SURGERY. THE VALVE ON THE CANNULA JACKET WAS REPORTED TO BE DAMAGED AND LEAKING GAS. THE TROCAR SLEEVE WAS REPLACED WITH ANOTHER SLEEVE FROM THE SAME BATCH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216219 ↗
• InjuryApr 20, 2026Melted; Environmental Particulates

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SURGICAL PROCEDURE, AT THE BEGINNING OF THE SURGERY AND DURING THE LAPAROSCOPY PROCESS USING THE ENERGY PLATFORM AND A NON-MEDTRONIC MONOPOLAR SPATULA, THE ENERGY WAS INITIALLY SET AT 20W FOR PURE CUT AND COAGULATION AND WAS THEN INCREASED TO 30W DUE TO INSUFFICIENT TISSUE EFFECT, AFTER WHICH A MATCH-SIZED FLAME OCCURRED AT THE NON-MEDTRONIC MONOPOLAR INSTRUMENT UPON ACTIVATION VIA THE MONOPOLAR FOOT SWITCH. THE DEVICE ALSO CAUGHT ON FIRE. THE MONOPOLAR INSTRUMENT WAS IMMEDIATELY WITHDRAWN FROM THE PATIENT¿S CAVITY AND DISCONTINUED, AND A DEVICE WAS INTRODUCED; UPON ACTIVATING DEVICE ENERGY INSIDE THE PATIENT¿S CAVITY, AN ENERGY OVERLOAD WAS REPORTED AND THERMAL DAMAGE (BURNING) TO THE SURGICAL CANNULA OCCURRED. THE DEVICE WAS ACTIVATED MULTIPLE TIMES IN SUCCESSION JUST PRIOR TO THE BURN. AN EXPLORATORY LAPAROSCOPIC INSPECTION OF THE ABDOMINAL CAVITY IDENTIFIED THERMAL LESIONS (BURN) ON THE ABDOMINAL WALL WITH ASSOCIATED TISSUE DAMAGE OR UNEXPECTED TISSUE LOSS, AND MELTED POLYMER DEBRIS INSIDE THE ABDOMINAL CAVITY THAT WAS REPORTED TO ORIGINATE FROM THE STRUCTURALLY COMPROMISED CANNULA. THE BURN WAS LOCATED AROUND THE TROCAR AND IN A REGIO

  Patient problems: Laceration(s)

  MAUDE report 24925167 ↗
• MalfunctionMar 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY IN THE ABDOMEN, THE DUCKBILL SEAL WAS DISLODGED. NO COMPONENT FELL INTO THE CAVITY OF THE PATIENT. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24696728 ↗
• MalfunctionMar 16, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING ENTRY OF THE ABDOMEN IN A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE SEAL OF THE DEVICE WAS DAMAGED AND AN AIR LEAK OCCURRED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605815 ↗
• MalfunctionFeb 6, 2026Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS A RUPTURE OF THE RUBBER MEMBRANE, WHICH CAUSED DEVICE LEAKAGE. THE DEVICE WAS DESCRIBED AS VERY FRAGILE, WITH THE MEMBRANE BREAKING EASILY. A NEW DEVICE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24282221 ↗
• MalfunctionDec 1, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC BYPASS PROCEDURE AT THE BEGINNING OF THE SURGERY, THE SEAL OF THE TROCAR WAS FOUND TO BE DAMAGED. THE TECHNICIAN PROVIDED ANOTHER CANNULA TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687911 ↗
• MalfunctionAug 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE FOR APPENDICITIS; DAMAGED SEALS WERE IDENTIFIED ON THE TWO DEVICES DURING TROCAR INSERTION. A NEW TROCAR WAS USED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851247 ↗
• MalfunctionJul 29, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC VIDEO GASTROPLASTY, WHEN THE 12 MM CANNULA WAS PASSING THROUGH THE CLIPPER, IT DAMAGED THE VALVE AND CAUSED AN AIR LEAK. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644820 ↗
• MalfunctionJul 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY USING THE SEAL DISENGAGED AND FELL INTO THE CAVITY OF THE PATIENT WHILE CHANGING INSTRUMENTS. THE SEAL WAS SUBSEQUENTLY RETRIEVED WITH THE GRASPER OUT OF THE CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586159 ↗
• MalfunctionJun 18, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE TROCAR EXHIBITED A SEALING DEFECT, RESULTING IN AIR OR GAS LEAKING FROM THE SEAL AND LOSS OF CO2 DURING THE PROCEDURE. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22285277 ↗
• MalfunctionJun 16, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, AT THE BEGINNING OF THE PROCEDURE, WHEN THE CLIPPER WAS INSERTED, THE DEVICE BEGAN TO LEAK CARBON DIOXIDE, AND THE CANNULA SEAL WAS DAMAGED. THE DEVICE WAS REPLACED WITH ANOTHER ONE TO RESOLVE THE ISSUE AND COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212473 ↗
• MalfunctionMay 30, 2025Decrease in Pressure; Detachment of Device or Device Component; Decrease in Pressure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A GASTROPLASTY BYPASS PROCEDURE, THE LENS DISENGAGED, AND THERE WAS A LOSS OF PNEUMOPERITONEUM. THE SURGICAL TIME WAS EXTENDED BY APPROXIMATELY TWENTY MINUTES DUE TO A PRODUCT PROBLEM. NO ADDITIONAL OPERATION WAS PLANNED TO CORRECT THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116668 ↗
• MalfunctionMay 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTROPLASTY BYPASS, THE SEAL DISENGAGED, BUT IT DID NOT FALL INTO THE PATIENT¿S CAVITY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22098905 ↗
• MalfunctionMay 5, 2025Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC VIDEO GASTROPLASTY PROCEDURE, THE DEVICE EXPERIENCED A DEVICE-RELATED ISSUE WHERE THE CANNULA LEAKED WITH THE INTRODUCTION OF FORCEPS, CAUSING A LOSS OF PNEUMOPERITONEUM. THE CANNULA BEGAN TO LEAK FROM THE START OF THE SURGERY. TO RESOLVE THE ISSUE, THE CANNULA WAS REPLACED WITH A TROCAR TO CONTINUE THE SURGERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965177 ↗
• MalfunctionApr 17, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A GASTROPLASTY BY VIDEOLAPAROSCOPY, A 12MM CANNULA HAD A SEALING DEFECT IN THE DIAPHRAGM, CAUSING CO2 LOSS AND AIR OR GAS LEAKAGE DURING THE LAPAROSCOPIC PROCEDURE. THE DEVICE WAS APPLIED TO THE DIAPHRAGM AT THE TIME OF THE ISSUE. THE CANNULA WAS REPLACED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21861477 ↗