Surgipro II VP-331XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521037632), received between Oct 25, 2017 and Jan 14, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2021Break; Break

  ACCORDING TO THE REPORTER, WHEN SUTURING THE LIVER VESSEL ON AN OPEN PROCEDURE, THE NEEDLE BROKE. THE DEVICE WAS CHANGED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11171750 ↗
• MalfunctionOct 25, 2017Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING AN OPEN AORTIC VALVE REPLACEMENT PROCEDURE. THE SUTURE WAS BEING USED WHILE CLOSING THE HOLE FROM THE CANNULA OF THE LV VENTING. THE SUTURE WAS TREATED OR HYDRATED PRIOR TO USE WITH SALINE. WHEN THE USER PERFORMED THE FIRST THROW HOLD AT TWO HOURS INTO THE PROCEDURE, THE SURFACE OF THE SUTURE FRAYED. AS A RESULT, COULD NOT PROCEED WITH THE SUTURE. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, USED ANOTHER SUTURE FROM THE SAME PACKAGING. ALSO, A NEEDLE OF ANOTHER SUTURE FROM THE SAME PACKAGING WAS DETACHED FROM THE STRAND WHILE THE NURSE TRIED TO PULL THE SUTURE WITH THE NEEDLE HOLDER OUT OF THE PACKAGE. THERE WAS NO PATIENT HARM. THE PATIENT OUTCOME IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6976301 ↗