Versaport Plus 177091PFRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20884521094281), received between Mar 14, 2022 and Nov 21, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.

• MalfunctionNov 21, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY FOR ENDOMETRIOSIS, WHEN THE CLAMP WAS INSERTED, THE MEMBRANE (CANNULA) RUPTURED. ANOTHER PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187382 ↗
• MalfunctionNov 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC TOTAL EXCISION OF ENDOMETRIOSIS, WHEN INSERTING A CLAMP, THE CANNULA MEMBRANE RUPTURED. ANOTHER PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18176403 ↗
• MalfunctionNov 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ENDOMETRIOSIS PROCEDURE, WHEN A LAPAROSCOPIC CLAMP WAS INSERTED, THE CANULA MEMBRANE (SEAL) RUPTURED. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18174315 ↗
• 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 18171207 ↗
• MalfunctionMar 14, 2022Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE OBTURATOR GOT STUCK IN THE CANNULA WHEN INSERTING. A DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13756227 ↗