Versaport ONB12SHFRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10884521181366), received between Jul 5, 2018 and Feb 17, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (10 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY WITH ROBOT-ASSISTED LIVER RESECTION, THE DEVICE SEAL WAS DAMAGED RESULTING IN PNEUMOPERITONEUM AIR/GAS LEAKAGE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24361707 ↗
• MalfunctionSep 19, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SEAL WAS BROKEN AND THERE WAS AN AIR LEAK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23093821 ↗
• MalfunctionJul 22, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOID COLECTOMY, AN ISSUE OCCURRED WITH THE DEVICE INVOLVING SEAL DAMAGE AND SEAL DETACHMENT DURING THE MESOCOLON TREATMENT PHASE AFTER LAPAROTOMY. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563996 ↗
• MalfunctionJan 31, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HIATAL HERNIA PROCEDURE, THE TROCAR WAS INVOLVED IN AN INCIDENT WHERE THE OBTURATOR/TROCAR BROKE, CREATING A HOLE IN THE DIAPHRAGM AND RESULTING IN A TEMPORARY INJURY.

  Patient problems: Perforation

  MAUDE report 21282699 ↗
• MalfunctionSep 9, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, AIR LEAKED FROM THE DEVICE AND THE SEAL 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 20169278 ↗
• MalfunctionJan 15, 2024Break; Detachment of Device or Device Component; Noise, Audible; Break; Detachment of Device or Device Component; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTAL RESECTION, AFTER THE STAPLER FOR THE 2ND FIRING WAS INSERTED AND ATTEMPTING TO APPROACH THE TISSUE A CRACKING SOUND WAS HEARD AND IT WAS FOUND THAT THE TIP OF THE INNER TUBE WAS BROKEN, AND A 5 MM TO 1 CM SEMICIRCULAR FRAGMENT FELL INTO THE ABDOMINAL CAVITY. AFTER ABOUT 20 MINUTES OF SEARCHING INSIDE THE ABDOMINAL CAVITY, THE FRAGMENT WAS CLAMPED WITH GRASPING FORCEPS AND REMOVED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18513734 ↗
• MalfunctionSep 28, 2023Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN THE GAUZE WAS CLAMPED WITH FORCEPS AND AN ATTEMPT WAS MADE TO INSERT IT INTO THE ABDOMINAL CAVITY, THE BLUE UPPER SEAL OF THE PORT GOT DAMAGED AND HAS COME OFF. IT FELL OFF INSIDE THE BODY, BUT WAS REMOVED WITH FORCEPS. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17836833 ↗
• MalfunctionSep 26, 2023Decrease in Pressure; Noise, Audible; Material Split, Cut or Torn; Decrease in Pressure; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ASSISTED DISTAL GASTRECTOMY DISSECTION, THERE WAS A PNEUMOPERITONEUM LEAKAGE DUE TO A DAMAGE TO THE SEAL PART, AND THE DEVICE MADE AN ABNORMAL SOUND. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17817615 ↗
• MalfunctionSep 28, 2022Break; Leak/Splash; Noise, Audible; Material Split, Cut or Torn; Break; Leak/Splash; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC RECTAL RESECTION, DURING THE LIGAMENT PROLAPSE, THE DEVICE WAS CRACKING, HAD AIR LEAKAGE, AND ABNORMAL NOISE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15496966 ↗
• MalfunctionSep 7, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, AIR LEAKED FROM THE TWO DEVICES DUE TO THE SEAL DAMAGE ON BOTH 5 MM AND 12 MM PORTS. THE BROKEN PIECE OF THE SEAL DID NOT FALL OFF; IT ONLY HAD A CRACK. EACH DEVICES WERE REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITHOUT AN PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374939 ↗
• MalfunctionMay 6, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LIVER RESECTION, APPROXIMATELY FOUR HOURS AFTER START OF THE PROCEDURE, BOTH DEVICES HAD SEAL DAMAGE AND AN AIR LEAKAGE OCCURRED. A NEW PRODUCT WAS TAKEN OUT AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14306389 ↗
• MalfunctionMar 28, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROXIMAL GASTRECTOMY PROCEDURE, AFTER STARTING TO USE THE DEVICE FOR ABOUT 30 MINUTES, THERE WAS A PNEUMOPERITONEUM LEAKAGE THAT OCCURRED. WHEN THE SEAL PART WAS CHECKED, IT WAS FOUND TO BE BROKEN LIKE TEARING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13929038 ↗
• MalfunctionFeb 2, 2022Leak/Splash; Decrease in Pressure; Noise, Audible; Leak/Splash; Decrease in Pressure; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRECTOMY, PNEUMOPERITONEUM LEAK OCCURRED AND THE PNEUMOPERITONEUM COULD NOT BE M AINTAINED ON THE FIVE DEVICES. IT WAS NOTED AIR OR GAS LEAKAGE FROM THE SEAL OCCURRED AT THE FIRST 12 MM TROCAR, THEN IT WAS ALSO OCCURRED TO OTHER TROCARS. AT THE END OF THE SURGERY, A PNEUMOPERITONEUM LEAK SOUND WAS HEARD FROM THE 5 MM TROCAR. THERE WAS A RAPID LOSS OF PNEUMOPERITONEUM NOTED. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13422725 ↗
• MalfunctionFeb 2, 2022Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRECTOMY, PNEUMOPERITONEUM LEAK OCCURRED AND THE PNEUMOPERITONEUM COULD NOT BE MAINTAINED ON THE FIVE DEVICES. IT WAS NOTED AIR OR GAS LEAKAGE FROM THE SEAL OCCURRED AT THE FIRST 12 MM TROCAR, THEN IT WAS ALSO OCCURRED TO OTHER TROCARS. AT THE END OF THE SURGERY, A PNEUMOPERITONEUM LEAK SOUND WAS HEARD FROM THE 5 MM TROCAR. THERE WAS A RAPID LOSS OF PNEUMOPERITONEUM NOTED. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13422709 ↗
• MalfunctionJul 7, 2021Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY, THE PORT SEAL WAS DAMAGED RESULTING IN AN INTERNAL FALL EVENT. A FOREIGN OBJECT WAS FOUND IN THE ABDOMINAL CAVITY AT THE END OF THE OPERATION. IT WAS STATED THAT COMPONENT WAS PART OF THE PORT¿S SEAL AND WAS COMPLETELY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12127276 ↗
• MalfunctionMay 13, 2021Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING IN OR OUT OF FORCEPS IN DISSECTION OF MEMBRANE IN A LAPAROSCOPIC RIGHT HEMICOLECTOMY, SURGEON NOTICED A BLACK MATERIAL AND SOON WAS KNOWN THAT IT WAS A FRAGMENT DUE TO SEAL DAMAGE. SURGEON USED ANOTHER TROCAR TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816921 ↗
• MalfunctionJan 6, 2021Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ASSISTED DISTAL GASTRECTOMY, WHEN CLIPPED TO A VESSEL, THE SEAL GOT DAMAGED WHEN A 10 MM CLIP MADE BY ANOTHER MANUFACTURER WAS INSERTED. IT DROPPED INTO THE BODY. THE DAMAGED SEAL'S FRAGMENT WAS NOTED AND IT WAS RETRIEVED WITH FORCEPS AND THE SURGICAL TIME WAS EXTENDED BY 15 MINUTES. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11123185 ↗
• MalfunctionDec 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LATTER HALF OF A PROCEDURE, THE CANNULA CAME OFF FROM THE TOP PORTION OF THE PORT. WHEN SEARCHING THE ABDOMINAL CAVITY, A MATERIAL LIKE BROKEN PIECE WAS FOUND. THE REPORTED TROCAR AND THE BROKEN PIECE WILL BE RETURNED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096227 ↗
• MalfunctionSep 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GYNE, THERE WAS A BLUE OBJECT IN THE SURGICAL FIELD. THE SEAL PART OF THE TROCAR WAS FOUND TO BE DAMAGED WHEN CHECKED. THE PART FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED WITH FORCEP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10513575 ↗
• MalfunctionNov 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN USING A 12MM PORT AT THE END OF A LAPAROSCOPIC RIGHT HEMICOLECTOMY, THE DOCTOR REMOVED THE UPPER SEAL AND TRIED TO REATTACH IT BUT THERE WAS NO CLICK SOUND FROM THE LOCK. WHEN CHECKED BY VISION, THE LEVER WHICH SHOULD RELEASE THE LOCK WENT DOWN SLIGHTLY AND WAS BENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8104535 ↗
• MalfunctionJul 5, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, 3 DEVICES WERE USED. A COMPETITOR'S TROCAR FOR SCOPE WAS ALSO BEING USED. DURING THE SURGERY, THE SURGEON FOUND A TRANSPARENT MATERIAL FALLEN IN THE PATIENT'S ABDOMINAL CAVITY AND RETRIEVED THE IT IMMEDIATELY. IT LOOKS LIKE A PLASTIC PIECE, BUT THEY COULDN'T IDENTIFY WHERE IT CAME FROM. AS THE PATIENT HAS NO MEDICAL HISTORY, THE MATERIAL IS THOUGHT TO HAVE FALLEN IN THIS SURGERY. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7663996 ↗