Versaport NB5STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521076747), received between Dec 28, 2017 and May 14, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, IT WAS NOTED THAT THE SEAL WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19315936 ↗
• MalfunctionSep 6, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING SLEEVE GASTRECTOMY, AT THE TIME ACCESSING THE ABDOMINAL CAVITY, THE OBTURATOR/TROCAR BROKE . NEW P RODUCTS WERE OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366616 ↗
• MalfunctionJul 13, 2021Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE PRODUCT¿S PACKAGING WAS RECEIVED AS DAMAGED. IT WAS STATED THAT THE SEAL OF THE DEVICE WAS ALSO DAMAGED. THE MALFUNCTION OCCURRED ON TWO DEVICES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159722 ↗
• MalfunctionJul 13, 2021Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE PRODUCT¿S PACKAGING WAS RECEIVED AS DAMAGED. IT WAS STATED THAT THE SEAL OF THE DEVICE WAS ALSO DAMAGED. THE MALFUNCTION OCCURRED ON TWO DEVICES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159701 ↗
• MalfunctionNov 4, 2019Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING PREPARATION OF A LAPAROSCOPIC PROCEDURE, THE OBTURATOR COULD NOT BE INSERTED INTO THE CANNULA WHEN THE INSTRUMENT WAS ASSEMBLED. OPENED NEW PRODUCTS TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9274829 ↗
• MalfunctionJan 8, 2018Device Packaging Compromised; Device Packaging Compromised

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RADICAL NEPHRECTOMY, THE DEVICE¿S SEAL WAS DAMAGED WHILE PREPARING IT TO INSERT TROCAR TO ESTABLISH THE SURGICAL APPROACH. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7172288 ↗
• MalfunctionDec 28, 2017Device Packaging Compromised; Packaging Problem; Device Packaging Compromised; Packaging Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY LAPAROSCOPIC RADICAL NEPHRECTOMY, WHILE PREPARING TO OPEN THE TROCAR FOR PUNCTURING, THE SEAL WAS DAMAGED ON THE PRODUCT PACKAGING. THEY CHANGED THE SURGICAL INSTRUMENTS TO COMPLETE THE CASE. THE PATIENT HAD NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7152420 ↗