Versaport 179094FRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20884521081274), received between Jul 12, 2016 and Nov 20, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE FOR ENDOMETRIOSIS, WHEN A LAPAROSCOPIC CLAMP WAS INSERTED, THE MEMBRANE OR SEAL WAS RUPTURED. ANOTHER PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18171173 ↗
• MalfunctionSep 22, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, THE DEVICE CANNULA BROKE. 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 12512572 ↗
• MalfunctionAug 25, 2020Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, ON LAPAROSCOPIC CHOLECYSTECTOMY, AT THE TIME OF REMOVING THE TROCAR FROM THE PACKAGING, THE OBTURATOR BROKE, SEPARATION WAS OBSERVED FROM THE SHUTTER HEAD AT THE POINT WHERE THE SHUTTER SYSTEM WAS ACTIVATED. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10451471 ↗
• MalfunctionJul 17, 2019Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRECTOMY PROCEDURE, THE SEAL WAS DAMAGED WHEN THE SUCTION TUBE WAS PLUGGED IN THE TROCAR. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8798897 ↗
• MalfunctionJul 16, 2019Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC NEPHRECTOMY, THE SURGEON WAS TRYING TO TAKE OUT THE SPECIMEN, BUT THE BAG DIDN'T FORM A DRAWSTRING BAG. WHEN WE TRIED TO PULL THE GREEN CIRCLE, THE BAG HAVE ALREADY TORE APART. THE TROCAR'S SEAL WAS DAMAGED. CHANGED THE RETRIEVAL BAG TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8793861 ↗
• MalfunctionJun 11, 2019Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE SURGEON TRIED TO REMOVE THE SUCTION/IRRIGATION SYSTEM FROM THE 5MM-TROCAR HE WAS NOT ABLE NOT PULL THE INSTRUMENT OUT OF THE TROCAR. HE HAD TO REMOVE THE WHOLE TROCAR WITH THE INSTRUMENT. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8687975 ↗
• MalfunctionSep 18, 2018Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE PROTECTOR BLUE PLASTIC PART THAT WAS AT THE TIP OF THE TROCAR DEVICE STAYED INSIDE, WHILE PULLING BACK AND IT SEPARATED FROM THE TIP PART OF THE TROCAR. THE DEVICE REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7886042 ↗
• MalfunctionJun 29, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HYSTERECTOMY, THE END OF THE CANNULA BROKE. THEY CHANGED IN TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7650868 ↗
• MalfunctionJun 29, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HYSTERECTOMY, THE END OF THE CANNULA BROKE. THEY CHANGED IN TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7650565 ↗
• MalfunctionJul 12, 2016Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A DONOR NEPHRECTOMY, AT THE FIRST USAGE THERE WERE DIFFICULTIES WHILE ENTERING TO THE ABDOMEN AND THE DEVICE COULD NOT CUT. THERE IS NO PROBLEM RELATED CANNULA. KNIFE/CUTTER DID NOT CUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5786616 ↗