Versaport ONB5STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10884521134232), received between Jun 13, 2016 and May 23, 2025 — classified as 6 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (17 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 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC SALPINGECTOMY, THE TOP OF THE 5MM. TROCAR BROKE OFF WHEN PULLING OUT THE 5MM. CAMERA. THE INCIDENT OCCURRED AT THE END OF THE CASE SO THE PROCEDURE WAS COMPLETED WITHOUT THE NEED FOR A NEW PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081705 ↗
• InjuryFeb 3, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Material Split, Cut or Torn; Detachment of Device or Device Component; Insufficient Device Problem Information; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC ADNEXECTOMY, THE SEAL OF TWO TROCARS WERE DAMAGED. A CT (COMPUTED TOMOGRAPHY) SCAN AFTER THE SURGERY REVEALED THAT THERE WERE METAL FRAGMENTS INSIDE THE BODY. THE FRAGMENTS HAVE A ROUND SHAPE OF ABOUT 3 MM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21292162 ↗
• InjuryFeb 3, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Material Split, Cut or Torn; Detachment of Device or Device Component; Insufficient Device Problem Information; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC ADNEXECTOMY, THE SEAL OF TWO TROCARS WERE DAMAGED. A CT (COMPUTED TOMOGRAPHY) SCAN AFTER THE SURGERY REVEALED THAT THERE WERE METAL FRAGMENTS INSIDE THE BODY. THE FRAGMENTS HAVE A ROUND SHAPE OF ABOUT 3 MM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21290738 ↗
• MalfunctionJan 24, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC SLEEVE GASTRECTOMY, WHILE INSERTION TO THE ABDOMEN, THE TIP OF TROCAR BROKE OFF. IT WAS NOTED THAT THE TIP OF THE DEVICE WAS FOUND ON THE PATIENT¿S FASCIA AND REMOVED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229412 ↗
• MalfunctionDec 26, 2024Precipitate in Device or Device Ingredient; Detachment of Device or Device Component; Precipitate in Device or Device Ingredient; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE IN A LAPAROSCOPIC PROCEDURE, THE SEAL OF THE TROCAR DISENGAGED. IT WAS ALSO REPORTED THAT WHEN THEY TOOK THE TROCAR OUT OF THE PACKAGING, IT HAD WHAT LOOKED LIKE LUBRICANT THAT LEAKED ALL OVER IT AND THE PAPER HOLDER. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21018531 ↗
• MalfunctionNov 27, 2024Detachment 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 PROCEDURE, THE SEAL OF THE THREE TROCARS WERE DAMAGED AND TRANSLUCENT DEBRIS FELL INTO THE CAVITY OF THE PATIENT. IT WAS CONFIRMED THAT THE FRAGMENTS WERE RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798185 ↗
• MalfunctionNov 27, 2024Detachment 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 PROCEDURE, THE SEAL OF THE THREE TROCARS WERE DAMAGED AND TRANSLUCENT DEBRIS FELL INTO THE CAVITY OF THE PATIENT. IT WAS CONFIRMED THAT THE FRAGMENTS WERE RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797899 ↗
• MalfunctionOct 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ABDOMINAL HYSTERECTOMY, THE TOP OF THE PORT DETACHED FROM THE CANNULA, AND IT COULD NOT BE RECONNECTED. THE SURGEON COULD NOT MAINTAIN THE INSUFFLATION, AND IT WAS NECESSARY TO REPLACE THE DEVICE WITH A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20429415 ↗
• MalfunctionAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PROCEDURE, THE TROCAR PUNCTURED THE BOWEL UPON INSERTION. THE DEVICE WAS REMOVED FROM THE INCISION SITE AND THE ISSUE WAS SURGICALLY FIXED. THE ISSUE LED TO 30 MINUTES OR MORE EXTENDED SURGICAL TIME.

  Patient problems: Tissue Breakdown; Unspecified Tissue Injury

  MAUDE report 19940031 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC OVARIAN CYST REMOVAL PROCEDURE, THE SURGEON PUNCTURED THE AORTA WITH THE DEVICE. THERE WAS A BLOOD LOSS OF MORE THAN 500CC DUE TO THE PRODUCT PROBLEM. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES, AND MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED TO PREVENT PERMANENT IMPAIRMENT OF FUNCTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 18812985 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE CLINICAL STUDY, THE SEAL CAME OFF FROM THE TOP OF THE TROCAR. IT THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18714726 ↗
• MalfunctionOct 21, 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 APPENDECTOMY, DURING TROCAR INSERTION, WHEN USING THE COMPETITOR'S DEVICES, A BLUE OBJECT CAME OUT AND ADHERED TO THE DISSECTOR. IT WAS NOTED THAT SOME DAMAGED HAD OCCURRED TO THE SEAL INSIDE THE THREE TROCARS. THERE WAS A SCRATCH THAT HIT THE BLADE OF THE COMPETITOR'S DEVICE. THE TROCAR WAS REMOVED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981623 ↗
• MalfunctionOct 21, 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 APPENDECTOMY, DURING TROCAR INSERTION, WHEN USING THE COMPETITOR'S DEVICES, A BLUE OBJECT CAME OUT AND ADHERED TO THE DISSECTOR. IT WAS NOTED THAT SOME DAMAGED HAD OCCURRED TO THE SEAL INSIDE THE THREE TROCARS. THERE WAS A SCRATCH THAT HIT THE BLADE OF THE COMPETITOR'S DEVICE. THE TROCAR WAS REMOVED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981620 ↗
• MalfunctionOct 2, 2023Difficult to Remove; Noise, Audible; Difficult to Remove; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRECTOMY, AT THE BEGINNING OF THE PROCEDURE, THE DEVICE MADE A STRANGE NOISE AND THE TROCAR COULD NOT BE DETACHED FROM THE CANNULA. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17857965 ↗
• MalfunctionMar 6, 2023Break; Product Quality Problem; Device Contamination with Chemical or Other Material; Break; Product Quality Problem; Device Contamination with Chemical or Other Material

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PARAESOPHAGEAL HERNIA REPAIR, WHILE ON INSERTION OF THE TROCARS, THE OBTURATOR BROKE. IT WAS MENTIONED THAT THE TROCARS SEEMED MORE BLUNT THAN USUAL AT THE TIP AND IT WAS VERY HARD TO PIERCE THROUGH THE TISSUE. THERE WAS SEEMED TO BE A ROUNDED PLASTIC PIECE ON THE OBTURATOR THAT IS NOT TYPICALLY THERE AND MADE IT VERY HARD TO ENTER THE ABDOMEN. THE TROCARS WERE INSERTED AND THE PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16491712 ↗
• MalfunctionNov 9, 2022Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE ROBOT ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY PROCEDURE, FROM THE START OF THE OPERATION, THE ACCESS PORT DID NOT MOVE FORWARD. THE INNER TUBE CANNOT BE REMOVED FROM THE OUTER TUBE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759776 ↗
• MalfunctionJul 1, 2022Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PART OF THE OBTURATOR WAS FOUND TO BE DENTED. THE OBTURATOR/TROCAR WAS RUPTURED ALSO.

  Patient problems: Insufficient Information

  MAUDE report 14893378 ↗
• MalfunctionJan 6, 2022Noise, Audible; Material Split, Cut or Torn; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC THORACOSCOPIC SUBTOTAL ESOPHAGECTOMY, WHILE IN THE ABDOMEN, THE PNEUMOPERITONEUM COULD NOT BE MAINTAINED, AND THE DEVICES MADE NOISE. THE SEALS WERE DAMAGED AND ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13180760 ↗
• MalfunctionDec 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SALPINGECTOMY PROCEDURE, WHILE ACCESSING, THE CANNULA BROKE AND A COMPONENT DISENGAGED INTO PATIENT CAVITY. THE COMPONENT WAS RETRIEVED AND REMOVED. THE TROCAR WAS REPLACED WITH A NEW ONE TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13054404 ↗
• MalfunctionNov 16, 2021Difficult to Insert; Detachment of Device or Device Component; Material Split, Cut or Torn; Difficult to Insert; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER DURING TOTAL LAPAROSCOPIC HYSTERECTOMY, WHEN INSERTING AND REMOVING SURGICAL DEVICE INTO AND OUT OF THE ABDOMINAL CAVITY, THE SLIPPAGE WAS POOR. IT WAS ALSO REPORTED THAT THE SEAL WAS DAMAGED AND COMING OFF. A NEW PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12819814 ↗
• MalfunctionJun 18, 2021Break; Packaging Problem; Break; Packaging Problem

  ACCORDING TO THE REPORTER, WHILE MAKING SKIN INCISION ANG INSERTING A PORT DURING A LAPAROSCOPIC SIGMOID RESECTION, THERE WAS A PROTRUDING PART ON THE PLASTIC NEAR THE TIP OF THE OBTURATOR. IT WAS ALSO VERY DIFFICULT TO INSERT AND REMOVE THE SLEEVE AND OBTURATOR. A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12025059 ↗
• MalfunctionJun 16, 2021Difficult to Remove; Packaging Problem; Difficult to Remove; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOM PROCEDURE, THE DEVICE'S OBTURATOR BROKE. THE TROCAR THAT BROKE WAS THE INITIAL TROCAR BEING PLACED, IN THE UMBILICUS. THE METAL TUBE PORTION OF THE OBTURATOR BROKE LOOSE FROM THE HUB. THE METAL TUBE WAS THEN STUCK INSIDE THE CANNULA. NOTHING FELL INTO THE PATIENT. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12011232 ↗
• MalfunctionJan 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHILE THE DOCTOR WAS INSERTING PRODUCT INTO THE TROCAR, THE BLUE SEAL INSIDE THE CANNULA BROKE OFF AND FELL INSIDE THE PATIENT. THE DOCTOR REMOVED THE TROCAR AND THE BLUE PIECES FROM THE PATIENT AND INSERTED A NEW TROCAR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11162819 ↗
• InjuryFeb 4, 2020Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPY, THE TROCAR BROKE, AND THE TROCAR TIP FELL INTO THE PATIENT'S CAVITY. THE TROCAR TIP WAS NOT RETRIEVED AND WAS LEFT IN PATIENT. THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9667215 ↗
• MalfunctionJul 1, 2019Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY FOR PROSTATE CANCER, WHEN THE BIPOLAR FORCEPS WAS INSERTED TO THE REPORTED TROCAR, A FOREIGN MATERIAL OF BLUE FIBROUS FORM WAS ADHERED TO THE FORCEPS. THE TIP OF THE FORCEPS WAS NOT SHARP BUT QUITE BLUNT. THE PART FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8747138 ↗

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-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-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-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-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-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-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