Versaport Plus 179078PFRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 20884521082684), received between Aug 21, 2017 and Nov 5, 2025 — classified as 1 death, 21 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Difficult to Insert; Leak/Splash; Difficult to Insert; Leak/Splash

  ACCORDING TO THE CLINICAL STUDY, INTRA-OPERATIVELY, WHEN THE INSTRUMENTS WERE INTRODUCED THROUGH THE TROCAR, GAS LEAKS WERE NOTICED. THE JOINT WAS STUCK IN THE DEVICE AND NOT WATERPROOF, LEADING TO GAS LOSSES AND THE LOSS OF PNEUMOPERITONEUM. THE PROCEDURE WAS EXTENDED DUE TO THE ISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476659 ↗
• MalfunctionSep 20, 2023Difficult to Insert; Retraction Problem; Difficult to Insert; Retraction Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE ISSUE OCCURRED DURING TROCAR INSERTION. THE DEVICE FAILED TO WORK AS IT WAS INTRODUCED INTO THE PATIENT'S STOMACH DUE TO A BLOCKAGE IN THE TROCAR. THIS BLOCKAGE MADE IT IMPOSSIBLE TO PASS THE STOMACH USING THE DEVICE. THE SPRING WAS BLOCKED AND SHOWED NO SIGNS OF DAMAGE BEFORE THE DEVICE WAS USED, PREVENTING THE BLADE FROM EXTENDING. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17781985 ↗
• MalfunctionAug 18, 2021Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER DURING LAPAROSCOPIC SURGICAL PROCEDURE OF THE ABDOMEN, THE TROCAR SLEEVE IS UNSEALED AT THE TIME OF ITS IMPLANTATION AT THE ABDOMEN. TO FIX THE ISSUE, ANOTHER TROCAR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338766 ↗
• MalfunctionMar 31, 2021Protective Measures Problem; Protective Measures Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, BLADE ON TROCAR DID NOT RETRACT WHEN WENT THROUGH ABDOMINAL WALL AND IT STAYED STICKING OUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11599057 ↗
• MalfunctionJul 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, THE SUTURING DEVICE WAS DIFFICULT TO LOAD, TOGGLE, AND UNLOAD. THE SURGEON THEN USED ANOTHER DEVICE IN ORDER TO RESOLVE THE ISSUE. THE PART OF TROCAR DEVICE APPEARS TO BE A SEAL OR O-RING OF SOME TYPE DISENGAGED AND FELL INTO THE CAVITY. THE SURGEON ABLE TO RETRIEVED THE COMPONENT AND THE DEVICE WAS ABLE TO BE USED FOR THE REST OF THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8799161 ↗
• MalfunctionJun 20, 2019Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THERE WAS SOMETHING THAT BLOCKED THE INSIDE OF THE TROCAR WHEN THEY WANTED TO PASS THE BAD. IT SHOULD BE NOTED THAT THE TROCAR HAS NOT BEEN USED AT ALL BEFORE. THEY FORCED THE PASSAGE IN THE TROCAR WITH GRASPING FORCEPS AND THEN CAN FIT THE BAG WITHOUT DIFFICULTY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8717847 ↗
• MalfunctionApr 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE PROCEDURE, WHILE DEVICE WAS BEING APPLIED ON THE ABDOMEN FOR ACCESS, THE SURGEON COMPLAINED THAT THE CANNULA BROKE OFF, IT WAS SEPARATED FROM THE TOP PORTION OF THE TROCAR AND THE SEAL DETACHED. NEW TROCAR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8530095 ↗
• MalfunctionApr 11, 2019Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING SLEEVE GASTRECTOMY, THE TROCAR WAS LOCKED IN THE SAFETY POSITION. THE BLADE DOES NOT COME OUT AND CANNOT PERFORATE THE PATIENT¿S ABDOMINAL WALL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8504890 ↗
• MalfunctionApr 4, 2019Break

  WHILE SURGEON WAS PUTTING IN TROCAR WITH CANNULA, THE PIECES BROKE. ALL PIECES WERE RETRIEVED. NOTHING WAS RETAINED BY THE PATIENT. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO HARM TO THE PATIENT. THE DEVICE WAS SAVED AND WILL BE RETURNED FOR FAILURE ANALYSIS. MANUFACTURER RESPONSE FOR LAPAROSCOPE, GENERAL PLASTIC SURGERY, VERSAPORT PLUS (PER SITE REPORTER). THE DEVICE WILL BE RETURNED FOR FAILURE ANALYSIS. ANY FURTHER CORRESPONDENCE WILL BE SHARED AS IT IS MADE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8482100 ↗
• MalfunctionMar 27, 2019Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY WITH HIATAL HERNIA PROCEDURE, WHILE THE SURGEON WAS PUTTING IN TROCAR WITH CANNULA, THE PIECES BROKE. ALL PIECES WERE RETRIEVED AND NOTHING FELL INTO THE PATIENT'S CAVITY. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8456741 ↗
• MalfunctionMar 15, 2019Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, THE INSIDE DIAMETER REDUCER PART OF THE 15MM TROCAR FELL INTO THE PATIENT¿S ABDOMEN AND WAS RETRIEVED WITH THE HELP OF A GRASPER. THE SEAL WAS DAMAGED AND DISENGAGED. THEY OPENED ANOTHER PRODUCT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8424695 ↗
• MalfunctionFeb 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SEAL ON THE TROCAR TOILET SEAT CAME OFF WHEN THEY FLIPPED OPEN THE LID. WHEN THEY OPEN THE FLIP TOP ON THE TOILET SEAT, THE WHITE RUBBER SEAL IS NO LONGER CONNECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8350006 ↗
• MalfunctionJan 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE CANNULA WHICH IS THE VALVE LEAKPROOF OF THE DEVICE WAS DETACHED FROM THE TOP PORTION OF THE PORT AND FALL INTO THE PATIENT 'S CAVITY THAT WAS RETRIEVED WITH A CLAMP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8261236 ↗
• MalfunctionDec 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE THE WHITE RUBBER SEAL ON THE REDUCER CAP CAME OFF. THE PROCEDURE WAS CONTINUED AND COMPLETED WITHOUT THE CAP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8176980 ↗
• MalfunctionDec 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE THE WHITE RUBBER SEAL ON THE REDUCER CAP CAME OFF. THE PRO CEDURE WAS CONTINUED AND COMPLETED WITHOUT THE CAP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8176958 ↗
• MalfunctionDec 7, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE THE WHITE RUBBER SEAL ON THE REDUCER CAP CAME OFF. THE PROCEDURE WAS CONTINUED AND COMPLETED WITHOUT THE CAP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8142309 ↗
• MalfunctionNov 15, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A GASTRIC BYPASS THE WHITE RUBBER SEAL IN THE REDUCER CAP FELL OFF FROM THE DEVICE. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8073458 ↗
• MalfunctionNov 2, 2018Difficult to Insert; Packaging Problem; Difficult to Insert; Packaging Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE OBTURATOR/TROCAR BROKE. THE PROBLEM HAS BEEN NOTICED ON SEVERAL TROCARS FROM THE SAME BATCH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 8034599 ↗
• DeathMar 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PIERCING PROCESS IN A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE SURGEON INSERTED THE DEVICE INTO THE FLANK AND PRICKED THE INFERIOR VENA CAVA, WHICH CAUSED BLEEDING AND ULTIMATELY DEATH. BLOOD LOSS WAS GREATER THAN 500 CC AND BLOOD TRANSFUSION WAS REQUIRED. THE PATIENT DIED. THE SURGEON REPORTED THERE WAS NO ISSUE WITH THE DEVICE AND THE DEATH WAS CAUSED BY HIS FAULT FOR PUNCTURING THE VENA CAVA.

  Patient problems: Blood Loss; Death

  MAUDE report 7352264 ↗
• MalfunctionAug 24, 2017Detachment Of Device Component; Packaging Problem; Detachment Of Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, PER ADDITIONAL INFORMATION RECEIVED DURING A LAPAROSCOPIC BARIATRIC PROCEDURE, THE GAS INLET OF THE DEVICE WAS CRACKED/BROKEN. THE LENS DISENGAGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6816937 ↗
• MalfunctionAug 23, 2017Detachment Of Device Component; Packaging Problem; Detachment Of Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, ON (B)(6) 2017, INTRA-OPERATIVELY IN A LAPAROSCOPIC PROCEDURE, THE DEVICE OBURATOR/TROCAR BROKE, ALSO THE GAS INLET OF THE DEVICE CRACKED AND THE RUBBER PART UNDER THE COVER WAS LEAVING FROM ITS PLACE IN THE CASE USING A 5MM TOOL. THEY REPLACED THE DEVICE TO COMPLETE THE CASE AND RESOLVE THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6815174 ↗
• MalfunctionAug 21, 2017Detachment Of Device Component; Packaging Problem; Detachment Of Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY IN A LAPAROSCOPIC PROCEDURE, THE DEVICE¿S GAS INLET WAS CRACKED AND THE RUBBER PART LOCATED UNDER THE COVER WAS SEPARATING FROM ITS PLACE WHILE USING 5 MM TOOL. THEY REPLACED THE DEVICE TO COMPLETE THE SURGERY AND RESOLVED THE ISSUE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6807773 ↗