Versaport Plus 179096PFRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20884521081311), received between Jul 17, 2017 and Nov 21, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2024Break; Retraction Problem; Break; Retraction Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, AT THE BEGINNING OF THE PROCEDURE, WHEN THE USER WAS TRYING TO ACTIVATE THE TROCAR, THE TROCAR WAS DAMAGED AND THE BLADE DID NOT LOWER, THE SCRUB NURSE MADE SEVERAL ATTEMPTS BUT IT DID NOT WORK. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745552 ↗
• MalfunctionOct 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE SEAL WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20419329 ↗
• MalfunctionApr 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN THE CLIP APPLIER WAS INSERTED, WHEN IT WAS EXTRACTED IT COMES OUT WITH REMAINS OF THE SEAL. TO RESOLVE THE ISSUE, THE SEAL REMAINS WAS REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19033627 ↗
• MalfunctionNov 21, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN A LAPAROSCOPIC CLAMP WAS INSERTED, THE DEVICE MEMBRANE OR SEAL RUPTURED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18188087 ↗
• MalfunctionFeb 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE WHITE PART (SEAL) DISCONNECTED FROM THE TROCAR.

  Patient problems: Insufficient Information

  MAUDE report 11272528 ↗
• MalfunctionJul 9, 2020Break; Break

  ACCORDING TO THE REPORTER, ON A RECTAL CANCER RESECTION, DURING INSERTION, THE CANNULA BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Information

  MAUDE report 10250260 ↗
• MalfunctionJan 29, 2020Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, AFTER OPENING THE PACKAGE PRIOR TO USE ON A LAPAROSCOPIC GALLBLADDER PROCEDURE, THE SEAL WAS DISENGAGED. A TROCAR WAS THEN REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9643155 ↗
• MalfunctionMay 31, 2019Leak/Splash; Packaging Problem; Leak/Splash; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL RESECTION OF THE RECTAL CANCER, WHEN ESTABLISHING THE PNEUMOPERITONEUM, THE PNEUMOPERITONEUM TUBE COLLAPSED AND LEAKED. THE REPLACEMENT OF THE NEW PUNCTURE DEVICE WAS DONE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8658717 ↗
• MalfunctionSep 5, 2018Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, THE BASE OF THE TROCAR IS BROKEN; RELEASED SO THAT WAS INSERTED INTO THE PATIENT. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7846636 ↗
• MalfunctionMay 7, 2018Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE TROCAR WAS LEAKING AND COULD NOT KEEP THE PNEUMO. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7490485 ↗
• MalfunctionNov 27, 2017Detachment Of Device Component; Mechanical Problem; Detachment Of Device Component; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHILE BEING APPLIED AT THE LAPAROSCOPIC ACCESS USING A TROCAR, THE DEVICE KNIFE WAS DIFFICULT TO ADVANCE AND THE LENS WERE DISCONNECTED. THEY CHANGED TO A NEW TROCAR TO COMPLETE THE CASE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7061104 ↗
• MalfunctionOct 23, 2017Leak/Splash; Packaging Problem; Leak/Splash; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE FIRST DEVICE HAD AIR OR GAS LEAKED FROM THE SEAL AND THE SECOND DEVICE HAD A BROKEN OBTURATOR/TROCAR. THEY REPLACED WITH ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6968911 ↗
• MalfunctionOct 20, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER: FOUND THAT THE SPRING HAD DETACHED FROM THE DEVICE. THE SEAL HAD DISENGAGED FROM THE PORT. COULD NOT USE THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6965773 ↗
• MalfunctionJul 17, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, PRIOR THE PROCEDURE, ONE DEVICE HAD A DISENGAGED SEAL. THE SECOND STAPLING DEVICE LEVER COULD NOT BE SQUEEZED, AND STAPLES PARTIALLY DEPLOYED BUT GOT STUCK IN THE END OF THE STAPLER. THIS ISSUE WAS NOTICED PRIOR TO USE AND THERE WAS NO PATIENT INVOLVED IN THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6719742 ↗