Versaport UNVCA11STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521215382), received between Nov 13, 2018 and Jan 2, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2024Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  ACCORDING TO THE REPORTER, WHEN THE 11-MM CANNULA PORT LEAKED, INSUFFLATION AIR FLOWED AT A HIGH RATE. WHEN AIR LEAKS, IT WILL LOSE PRESSURE IN THE ABDOMEN, CAUSING AN ISSUE WITH VISUALIZATION UNTIL THE INSUFFLATORS CAN CATCH UP.

  Patient problems: Insufficient Information

  MAUDE report 18429467 ↗
• MalfunctionDec 29, 2023Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE 11-MM CANNULA PORT LEAKED, INSUFFLATION AIR FLOWED AT A HIGH RATE. WHEN AIR LEAKS, IT WILL LOSE PRESSURE IN THE ABDOMEN, CAUSING AN ISSUE WITH VISUALIZATION UNTIL THE INSUFFLATORS CAN CATCH UP.

  Patient problems: Insufficient Information

  MAUDE report 18419565 ↗
• MalfunctionJul 8, 2019Leak/Splash; Packaging Problem; Leak/Splash; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY, THE PORT STARTED LEAKING IMMEDIATELY. THE TOP PORTION DETACHED FROM CANNULA DEPRESSING RELEASE LEVER ABOVE STOPCOCK. ANOTHER CANNULA WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8769801 ↗
• MalfunctionNov 30, 2018Detachment of Device or Device Component; Device Contamination with Chemical or Other Material; Packaging Problem; Detachment of Device or Device Component; Device Contamination with Chemical or Other Material; Packaging Problem

  ACCORDING TO THE REPORTER DURING LAPAROSCOPIC CHOLECYSTECTOMY, THERE WAS A LITTLE PIECE OF BLUE FABRIC, FROM THE SEAL WHICH IS SEEN IN THE ATTACHED PHOTOS. THE FABRIC FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8121049 ↗
• MalfunctionNov 13, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE SEAL DISENGAGED AND FELL INTO THE PATIENT CAVITY, IT WAS RETRIEVED BY THE SURGEON USING GRASPER. THEY THEN USED 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 8063849 ↗