Versaport Plus NB15STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10884521076549), received between Mar 30, 2017 and Jun 11, 2026 — classified as 43 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (23 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE PROCEDURE AT INSERTION, THE DEVICE HAD A DAMAGED SEAL. THE TROCAR 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 25467321 ↗
• MalfunctionMar 7, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, UPON INTRODUCTION OF TROCAR INTO PATIENT, THE TROCAR BROKE. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18860458 ↗
• MalfunctionNov 10, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, THE TROCAR BROKE ITS MEMBRANE AND LEAKED OUT. RE-POSITIONING AND RE-RUPTURE OF THE MEMBRANE WERE PERFORMED. ANOTHER TROCAR WAS GIVEN TO THE SURGEON TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18114653 ↗
• MalfunctionSep 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, WHEN FINALLY FINISHING THE CASE AND CHECKING EVERYTHING BEFORE REMOVING THE TROCARS, IT WAS NOTICED THAT THE SEALING PART ON TOP OF THE TROCAR BROKE OFF AND FELL INTO THE PATIENT CAVITY. TO RESOLVE THE ISSUE, THE BROKEN PART WAS REMOVED FROM THE CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17811483 ↗
• MalfunctionMay 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ESOPHAGECTOMY IVOR LEWIS, WHEN INSTRUMENT WAS BEING INSERTED INTO THE TROCAR, THE 15 MILLIMETER SEAL DISENGAGED AND FELL INTO THE PATIENT'S ABDOMEN. THE SURGEON WAS ABLE TO RETRIEVE THE SEAL WITH A GRASPER. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16853733 ↗
• MalfunctionJan 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC SALPINGO OOPHORECTOMY PROCEDURE, THE SPECIMEN WAS BEING REMOVED FROM PATIENT TROUGH 25MM TROCAR. THE SEAL FROM THE TROCAR WAS DISLODGED AND FELL INTO PATIENT CAVITY. INITIALLY THIS WAS NOT OBSERVED BY SURGEON UNTIL LATER OF THE CASE. THE BLUE SEAL FROM THE TROCAR WAS RETRIEVED AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16107815 ↗
• MalfunctionDec 12, 2022Break; Detachment of Device or Device Component; Material Split, Cut or Torn; Break; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHILE STAPLING THE STOMACH, THE DEVICE DID NOT FIRE, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE EVEN WHEN THE GREEN BUTTON WAS PRESSED. A NEW HANDLE WAS USED TO RESOLVE THE ISSUE. THE SEAL OF THE PORT USED WAS DAMAGED, THE CANNULA BROKE, AND THE CANNULA DETACHED FROM THE TOP PORTION OF THE PORT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15960639 ↗
• MalfunctionNov 23, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE, DURING TROCAR INSERTION, 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 15856618 ↗
• MalfunctionNov 17, 2022Leak/Splash; Detachment of Device or Device Component; Noise, Audible; Leak/Splash; Detachment of Device or Device Component; Noise, Audible

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, AS SOON AS THE PHYSICIAN INTRODUCE THE INSTRUMENT INSIDE THE TROCAR, THE SEAL FROM THE 5MILLIMETER CONVERTER FELL OFF INTO THE ABDOMINAL CAVITY. IT WAS ALSO STATED THAT THE TROCAR VALVE FELL INTO THE CAVITY AND WAS RETRIEVED BY USING A GRASPER. THERE WAS ALSO AIR OR GAS LEAK FROM THE SEAL AND THE DEVICE MADE A STRANGE NOISE. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15816629 ↗
• MalfunctionOct 31, 2022Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, UPON INSERTION TO THE PATIENT'S BODY, THE TROCAR PORT (ONE PIECE OBTURATOR) BROKE INTO THREE PIECES.

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

  MAUDE report 15704377 ↗
• MalfunctionDec 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY, THE RUBBER SEAL OF THE TROCAR DISENGAGED INTO THE PATIENT'S CAVITY. THE SURGEON DISCOVERED THE ISSUE AT THE END OF THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13042777 ↗
• MalfunctionJun 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHILE CHECKING THE CAVITY THE SURGEON NOTICED THAT A RUBBER PART OF THE DEVICE DISENGAGED AND FELL INTO PATIENT CAVITY. THE SURGEON MANAGED TO REMOVE THE RUBBER PART BY USING A GRASPER THROUGH THE PORT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12066838 ↗
• MalfunctionJun 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHILE CHECKING THE CAVITY THE SURGEON NOTICED THAT A RUBBER PART OF THE DEVICE DISENGAGED AND FELL INTO PATIENT CAVITY. THE SURGEON MANAGED TO REMOVE THE RUBBER PART BY USING A GRASPER THROUGH THE PORT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12066755 ↗
• MalfunctionApr 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, THE TOILET SEAT WAS PUT ONTO THE INSTRUMENT AS A 5MM GRASPER WAS BEING INSERTED INTO THE DEVICE. PER THE SURGEON THE GRASPER MUST HAVE DISENGAGED THE SEAL AND WAS IN THE CANNULA OF THE TROCAR, THE TOILET SEAT WAS FLIPPED UP AND AN 8-10MM DEVICE WAS THEN INSERTED INTO THE TROCAR. THE WHITE SEAL WRAPPED AROUND THE INSTRUMENT AND WAS PRESENT ON THE CAMERA. IT WAS IMMEDIATELY REMOVED FROM THE DEVICE AND THE PATIENT. A NEW DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11723949 ↗
• MalfunctionApr 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, A RUBBER STOPPER COMPONENT FROM DEVICE FELL INTO THE PATIENT'S CAVITY. TO RESOLVE THE ISSUE, THE SURGEON HAD TO RETRIEVE THE COMPONENT FROM THE CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716400 ↗
• MalfunctionOct 2, 2020Leak/Splash; Detachment of Device or Device Component; Packaging Problem; Leak/Splash; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, WHILE USING THE SUTURING DEVICE IT WAS DIFFICULT TO TOGGLE. WHEN THE STAPLER WAS FIRED, THERE WERE INCOMPLETE STAPLE LINE CENTRALLY. THE DEVICE TROCAR ALSO HAD DAMAGE SEAL, AND HAD AN AIR OR GAS LEAK FROM THE SEAL. IN ADDITION THE GASKET FROM THE TROCAR FELL INTO THE ABDOMINAL CAVITY. TO RESOLVE THE ISSUE ANOTHER SUTURING DEVICE WAS USED, ANOTHER STAPLER FROM OTHER COMPANY WAS USED, AND THE TROCAR WAS CONTINUED TO USED BY THE SURGEON EVEN THOUGH IT WAS LEAKING. THE DEVICE COMPONENT FROM THE TROCAR ABLE TO RETRIEVED BY THE SURGEON USING GRASPER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10618480 ↗
• MalfunctionAug 5, 2020Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE RESECTION OF THE STOMACH, THE SEAL OF THE TROCAR WAS DAMAGED. IT WAS ALSO STATED THAT THE SURGEON USED A STAPLER, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT THE HANDLE COULD NOT BE SQUEEZED. THE STAPLER WAS NOT ABLE TO FIRE. A NEW TROCAR, HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10370413 ↗
• MalfunctionJul 9, 2020Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING TROCAR INSERTION ON A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE SEAL OF THE DEVICE DISENGAGED AND WAS DAMAGED. THE CANNULA ALSO DETACHED FROM THE TOP PORTION OF THE PORT. THE TOP DID NOT ¿SEAT¿ PROPERLY. ANOTHER TROCAR WAS THEN USED. IT WAS ALSO STATED THAT THE STAFF DID NOT REALIZE THAT THE PLASTIC PIECE HAD FALLEN OFF INTO THE PATIENT¿S CAVITY UNTIL THEY WERE IRRIGATING AT THE END OF THE PROCEDURE. THE PLASTIC PIECE WAS RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10251259 ↗
• MalfunctionJun 26, 2020Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, THE CANNULA DETACHED FROM TOP OF THE PORT. IT WAS THEN REPLACED WITH A NEW ONE, BUT THE SEAL KEEPS POPPING OFF. THE CLEAR WHITE RUBBER SEAL FINALLY CAME OUT AND COULD NOT BE ATTACHED. A THIRD PORT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10203685 ↗
• MalfunctionApr 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING INSERTION OF INSTRUMENTS ON A LAPAROSCOPIC PROCEDURE, THE WHITE SEAL ON THE TOILET SEAT DISENGAGED AND FELL INTO THE PATIENT¿S CAVITY. THE DEVICE WAS FULLY RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988993 ↗
• MalfunctionMar 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, WHILE GAINING ACCESS INTO THE ABDOMEN, THE ENTIRE HUB OF THE TROCAR POPPED OFF. A NEW PRODUCT WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9795973 ↗
• MalfunctionFeb 5, 2020Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, DURING TRANSACTION OF ANTRUM, THE WHITE RUBBER ON THE CONVERTER FELL INTO THE CAVITY OF THE PATIENT. IT WAS FOUND ON THE OMENTUM AND THE AN ABNORMALITY WAS FOUND ON THE CONVERTER. THE SURGEON RETRIEVED THE FALLEN PART. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9670648 ↗
• MalfunctionDec 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LEFT NEPHRECTOMY, WHILE DISSECTING THE TISSUES AROUND THE KIDNEY, THE RUBBER IN THE PORT DISLOCATED, THE SEAL ON THE REDUCER WAS DISLODGED. THEY REPLACED WITH ANOTHER PORT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9410769 ↗
• MalfunctionAug 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, THE EYEBALL OF THE TROCAR DISLOCATED FROM ITS PLACE. THE LENS DISENGAGED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8928888 ↗
• MalfunctionJun 18, 2019Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, WHEN THE SURGEON PLACE THE DEVICE TO THE PATIENT, THE DEVICE BROKE AND THE SEAL DISENGAGED FROM THE CANNULA. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707863 ↗