Syneture VLOCN2146Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521762534), received between Jul 31, 2020 and Jun 25, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A ROBOTIC VENTRAL HERNIA REPAIR, WHEN CLOSING THE ABDOMINAL WALL, THE SUTURE STRAND BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610388 ↗
• MalfunctionJul 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHILE SUTURING, THE SUTURE BROKE AT THE SWAGE POINT. SAME SUTURE WAS USED 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 17357370 ↗
• MalfunctionJul 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH REPAIR, WHILE CLOSING THE HERNIA DEFECT, THE SUTURE BROKE AT THE SWAGE POINT DURING THE LAST BITE OF THE CONTINUOUS SUTURING. NO DEVICE COMPONENT FELL INTO THE CAVITY OF THE PATIENT. THE DETACHED SUTURE WAS ENOUGH TO COVER THE CLOSURE OF THE DEFECT, SO SURGEON FINISHED THE SUTURING AND CONTINUED WITH THE PROCEDURE FOLLOWING THE NORMAL STEPS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347712 ↗
• MalfunctionOct 14, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING THE ROBOTIC LAPAROSCOPIC PROCEDURE, THE SUTURE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 15611939 ↗
• InjuryJul 31, 2020Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE DEVICE WAS USED AT END OF PROCEDURE TO CLOSE THE PATIENT'S VAGINAL CUFF. FOLLOWING LAPAROSCOPIC ROBOTIC HYSTERECTOMY, THE PATIENT WENT INTO THE DOCTOR¿S OFFICE AND THE DOCTOR TRIED TO CUT OUT THE SUTURE OUT OF THE VAGINAL AREA BUT COULD NOT GET ALL THE SUTURE. THIS WAS CAUSES PAIN TO THE PATIENT. IT WAS ALSO REPORTED THAT PATIENT'S BOYFRIEND'S PENIS HAS BEEN CUT BY THE BARBS UPON INTERCOURSE.

  Patient problems: No Code Available; Pain

  MAUDE report 10349418 ↗