Versaport ONB5SHFRecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10884521134225), received between Oct 10, 2016 and Jun 20, 2025 — classified as 48 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (29 reports).

6 other recalls cover devices cleared under the same FDA submission (K112349); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE CANNULA, OBTURATOR, AND TROCAR BROKE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302737 ↗
• MalfunctionJun 25, 2024Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE INNER TUBE HEAD WAS CRACKED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19607234 ↗
• MalfunctionMar 22, 2024Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TRANSABDOMINAL PRE-PERITONEAL (TAPP) INGUINAL HERNIA REPAIR SURGERY, DURING RESECTION OF THE PREPERITONEAL SPACE, AIR LEAKAGE OCCURRED FROM THE SEAL PART, AND PNEUMOPERITONEUM COULD NO LONGER BE MAINTAINED. IT WAS NOTED THAT THERE WAS RAPID A LOSS OF ABDOMINAL PRESSURE. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961764 ↗
• MalfunctionFeb 14, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL (TAPP) INGUINAL HERNIA, THE SEAL PORTION WAS DAMAGED AND T HE GAS IN THE PNEUMOPERITONEUM LEAKED. THE DEVICE WAS USED AS IS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707681 ↗
• MalfunctionJan 3, 2024Leak/Splash; Noise, Audible; Material Split, Cut or Torn; Leak/Splash; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC RECTAL RESECTION, WHILE ON RESECTION THE SURROUNDINGS OF RECTUM, THERE WAS SEAL DAMAGE, AIR OR GAS LEAKAGE FROM THE SEAL AND ABNORMAL SOUND FROM THE DEVICE FOR THE FOUR DEVICES. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18438480 ↗
• MalfunctionJan 3, 2024Leak/Splash; Noise, Audible; Material Split, Cut or Torn; Leak/Splash; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC RECTAL RESECTION, WHILE ON RESECTION THE SURROUNDINGS OF RECTUM, THERE WAS SEAL DAMAGE, AIR OR GAS LEAKAGE FROM THE SEAL AND ABNORMAL SOUND FROM THE DEVICE FOR THE FOUR DEVICES. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18438400 ↗
• MalfunctionMay 18, 2023Leak/Splash; Noise, Audible; Material Split, Cut or Torn; Leak/Splash; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC RECTAL RESECTION, THERE WAS A CRACK INTO THE SEAL OF TWO TROCARS. AIR HAS LEAKED. ABNORMAL NOISE ALSO OCCURRED WHEN THE FORCEPS WERE INSERTED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16956109 ↗
• MalfunctionMay 18, 2023Leak/Splash; Noise, Audible; Material Split, Cut or Torn; Leak/Splash; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC RECTAL RESECTION, THERE WAS A CRACK INTO THE SEAL OF TWO TROCARS. AIR HAS LEAKED. ABNORMAL NOISE ALSO OCCURRED WHEN THE FORCEPS WERE INSERTED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16956068 ↗
• MalfunctionMay 10, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC HERNIA PROCEDURE, WHILE DISSECTING THE CAVITY THROUGH THE TROCAR, THERE WAS AIR OR GAS LEAKED FROM THE SEAL. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE SINCE THE SURGEON NEEDED TO FIND WHERE THE LEAK WAS FROM THE PRESSURE. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 16903026 ↗
• MalfunctionApr 28, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RECTAL RESECTION, 2 HOURS AFTER BEING USED ON PERIRECTAL RESECTION, THE SEAL OF THE TWO TROCARS WERE DAMAGED, CAUSING AIR LEAKAGE. ABNORMAL SOUND WAS ALSO HEARD FROM THE DEVICES. TWO MORE TROCARS WERE TAKEN OUT TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16838752 ↗
• MalfunctionApr 28, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RECTAL RESECTION, 2 HOURS AFTER BEING USED ON PERIRECTAL RESECTION, THE SEAL OF THE TWO TROCARS WERE DAMAGED, CAUSING AIR LEAKAGE. ABNORMAL SOUND WAS ALSO HEARD FROM THE DEVICES. TWO MORE TROCARS WERE TAKEN OUT TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16838608 ↗
• MalfunctionDec 20, 2022Leak/Splash; Noise, Audible; Material Split, Cut or Torn; Leak/Splash; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING THE LOWER ANTERIOR RESECTION, WHILE ON DETACHMENT AROUND THE RECTUM, A TOTAL OF FOUR TROCARS HAD AN AIR LEAKAGE. IT WAS ALSO STATED THAT THERE WAS ABNORMAL NOISE DUE TO SEAL DAMAGE. A NEW ONE WAS BROUGHT OUT, BUT THE SEAL WAS DAMAGED AGAIN. ALL DEFECTIVE PRODUCTS WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16019422 ↗
• MalfunctionDec 20, 2022Leak/Splash; Noise, Audible; Material Split, Cut or Torn; Leak/Splash; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING THE LOWER ANTERIOR RESECTION, WHILE ON DETACHMENT AROUND THE RECTUM, A TOTAL OF FOUR TROCARS HAD AN AIR LEAKAGE. IT WAS ALSO STATED THAT THERE WAS ABNORMAL NOISE DUE TO SEAL DAMAGE. A NEW ONE WAS BROUGHT OUT, BUT THE SEAL WAS DAMAGED AGAIN. ALL DEFECTIVE PRODUCTS WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16018931 ↗
• MalfunctionDec 20, 2022Leak/Splash; Noise, Audible; Material Split, Cut or Torn; Leak/Splash; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING THE LOWER ANTERIOR RESECTION, WHILE ON DETACHMENT AROUND THE RECTUM, A TOTAL OF FOUR TROCARS HAD AN AIR LEAKAGE. IT WAS ALSO STATED THAT THERE WAS ABNORMAL NOISE DUE TO SEAL DAMAGE. A NEW ONE WAS BROUGHT OUT, BUT THE SEAL WAS DAMAGED AGAIN. ALL DEFECTIVE PRODUCTS WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16018894 ↗
• MalfunctionDec 20, 2022Leak/Splash; Noise, Audible; Material Split, Cut or Torn; Leak/Splash; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING THE LOWER ANTERIOR RESECTION, WHILE ON DETACHMENT AROUND THE RECTUM, A TOTAL OF FOUR TROCARS HAD AN AIR LEAKAGE. IT WAS ALSO STATED THAT THERE WAS ABNORMAL NOISE DUE TO SEAL DAMAGE. A NEW ONE WAS BROUGHT OUT, BUT THE SEAL WAS DAMAGED AGAIN. ALL DEFECTIVE PRODUCTS WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16018571 ↗
• MalfunctionDec 20, 2022Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRECTOMY, THE SEAL WAS DAMAGED AND WHEN USING THE POWER DEVICE, IT COULD NOT BE SMOOTHLY INSERTED AND RETRACTED FROM THE TROCAR. A GEL WAS APPLIED ON THE POWER DEVICE SHAFT TO DEAL WITH IT, BUT IT WAS NOT QUITE GOOD. A NEW DEVICE WAS USED BUT THE SAME SITUATION OCCURRED, SO THE PRODUCT FROM ANOTHER COMPANY WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16014284 ↗
• MalfunctionDec 20, 2022Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRECTOMY, THE SEAL WAS DAMAGED AND WHEN USING THE POWER DEVICE, IT COULD NOT BE SMOOTHLY INSERTED AND RETRACTED FROM THE TROCAR. A GEL WAS APPLIED ON THE POWER DEVICE SHAFT TO DEAL WITH IT, BUT IT WAS NOT QUITE GOOD. A NEW DEVICE WAS USED BUT THE SAME SITUATION OCCURRED, SO THE PRODUCT FROM ANOTHER COMPANY WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16014249 ↗
• MalfunctionDec 20, 2022Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRECTOMY, THE SEAL WAS DAMAGED AND WHEN USING THE POWER DEVICE, IT COULD NOT BE SMOOTHLY INSERTED AND RETRACTED FROM THE TROCAR. A GEL WAS APPLIED ON THE POWER DEVICE SHAFT TO DEAL WITH IT, BUT IT WAS NOT QUITE GOOD. A NEW DEVICE WAS USED BUT THE SAME SITUATION OCCURRED, SO THE PRODUCT FROM ANOTHER COMPANY WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16014219 ↗
• MalfunctionNov 4, 2022Leak/Splash; Noise, Audible; Material Split, Cut or Torn; Leak/Splash; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC AMPUTATION RECTI, A 5 MM TROCAR FOR EXCLUSION WITH THE FORCEPS HELD BY THE ASSISTANT WHEN SEPARATION OF THE PERIRECTAL, HAD AIR LEAK AND MADE AN ABNORMAL NOISE. IT WAS ALSO NOTED THAT THERE WAS CRACK IN THE SEAL. THE DEVICE WAS REPLACED WITH A NEW ONE AND THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15739603 ↗
• 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 15374952 ↗
• MalfunctionAug 31, 2022Leak/Splash; Noise, Audible; Material Split, Cut or Torn; Leak/Splash; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCTECTOMY, WHILE THE DEVICE WAS HANDLED BY AN ASSISTANT, THE PORT WHERE THE FORCEPS WERE NOT PUT IN AND TAKEN OUT SO MUCH, CRACKED IN THE FIRST SEAL AFTER ABOUT 2 HOURS OF USE, AND THERE WAS AN AIR LEAKAGE THAT OCCURRED. WHEN IT WAS SEVERE, THERE WAS A GRUNT SOUND SOUNDED, AND BUBBLES COME OUT FROM THE GAP IN THE INSERTION PORT WHEN INSERTING THE FORCEPS. THE DEVICE WAS REPLACED THAT COMPLETE THE CASE AND THERE WAS NO PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328500 ↗
• MalfunctionAug 30, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, AROUND TWO HOURS AFTER THE START OF THE SURGERY, ON TWO DEVICES, WHEN THE FORCEPS WERE INSERTED, THE PNEUMOPERITONEUM LEAKED. WHEN THE FORCEPS WERE REMOVED, THE PNEUMOPERITONEUM WAS MAINTAINED. IT WAS ALSO NOTED THAT THE SEAL WAS DAMAGED. TO RESOLVE THE ISSUE, A DIFFERENT PRODUCT WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15319787 ↗
• MalfunctionAug 17, 2022Leak/Splash; Noise, Audible; Material Split, Cut or Torn; Leak/Splash; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS 5 MM TROCAR SEAL DAMAGED AND GAS LEAK OCCURRED. THERE WAS AN ABNORMAL SOUND HEARD FROM THE DEVICE. TWO DEVICE HAD SEAL DAMAGED AND WERE USED IN ONE CASE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15241609 ↗
• MalfunctionJul 20, 2022Leak/Splash; Noise, Audible; Material Split, Cut or Torn; Leak/Splash; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, AIR LEAKAGE OCCURRED DUE TO SEAL DAMAGE FROM TWO 5MM PORTS DURING LAPAROSCOPIC RECTAL AMPUTATION. SOUND WAS ALSO HEARD. NEW PORTS WERE TAKEN OUT AS REPLACEMENT.

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

  MAUDE report 15068216 ↗
• MalfunctionJul 20, 2022Leak/Splash; Noise, Audible; Material Split, Cut or Torn; Leak/Splash; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, AIR LEAKAGE OCCURRED DUE TO SEAL DAMAGE FROM TWO 5MM PORTS DURING LAPAROSCOPIC RECTAL AMPUTATION. SOUND WAS ALSO HEARD. NEW PORTS WERE TAKEN OUT AS REPLACEMENT.

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

  MAUDE report 15068155 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112349. One submission often covers many models, so check the product and lot details in each record.

• Z-1472-2013 · May 6, 2013 · Terminated
  Versaport Bladeless Optical Fixation Cannula - 5mm Product Code: ONBFCA5ST The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general,
• Z-1467-2013 · May 6, 2013 · Terminated
  Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5LGF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gyneco
• Z-1469-2013 · May 6, 2013 · Terminated
  Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ONB5STF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic,
• Z-1470-2013 · May 6, 2013 · Terminated
  Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gyne
• Z-1471-2013 · May 6, 2013 · Terminated
  Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA5SH The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, ge
• Z-1468-2013 · May 6, 2013 · Terminated
  Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product Code: ONB5SHF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynec