Surgipro II VP-733-XRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521038783), received between Sep 5, 2017 and Aug 7, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 18, 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.

• MalfunctionAug 7, 2023Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LIVER OPEN PROCEDURE, WHILE ON THE VESSEL, THE THREE NEEDLES BROKE AND A NEEDLE FELL INTO THE PATIENT CAVITY AND WAS RETRIEVED, THERE WAS A BLOOD LOSS OF 500CC BUT DID NOT REQUIRE A BLOOD TRANSFUSION. THE SURGICAL TIME WAS EXTENDED TO 30 MINUTES OR MORE. A NEW SUTURE FROM A DIFFERENT BOX WAS USED TO RESOLVE THE ISSUE. THERE WAS NO SERIOUS INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17475598 ↗
• MalfunctionAug 31, 2022Break; Break

  ACCORDING TO THE REPORTER, ON AN OPEN AXILLARY-POPLITEAL BYPASS GRAFT, WHILE CLOSING THE ANASTOMOSIS DOING A RUNNING SUTURING TECHNIQUE, THE THREAD BROKE. FIVE SUTURES FAILED WHILE SECURING ANASTOMOSIS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331335 ↗
• MalfunctionDec 15, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CARDIOVASCULAR PROCEDURE, THE THREAD OF THE DEVICES BROKE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13009549 ↗
• MalfunctionDec 15, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CARDIOVASCULAR PROCEDURE, THE THREAD OF THE DEVICES BROKE. SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13009548 ↗
• MalfunctionJul 8, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD RUPTURED. A NEW PRODUCT WAS TAKEN OUT AND USED IT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139023 ↗
• MalfunctionMar 2, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING CLOSURE OF THE DURA ON AN OPEN POSTERIOR DECOMPRESSION AND CHIARI SURGERY, WHEN TYING ONE KNOT AND USED A RUNNING STITCH, THE THREAD BROKE. IT WAS STATED THAT IT HAPPENED IN FOUR DEVICES DURING SAME CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9774426 ↗
• MalfunctionJun 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN THE FIRST PACKET WAS OPENED IN THE CASE OF EYELID PTOSIS REPAIR, THE NEEDLE WAS FOUND TO BE DISENGAGED. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8738132 ↗
• MalfunctionFeb 6, 2019Break; Packaging Problem; Break; Packaging Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE WAS BROKEN IN PACKAGE PRIOR TO IT BEING TAKEN OUT. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8312638 ↗
• MalfunctionNov 1, 2017Break; Break

  ACCORDING TO THE REPORTER, ON (B)(6) 2017, INTRA OPERATIVELY, THE SUTURE KEEPS BREAKING WHEN TIED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6993088 ↗
• MalfunctionSep 5, 2017Break; Break

  DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, THE DEVICE THREAD BROKE. THEY CHANGED THE DEVICE TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6843101 ↗