Syneture VLOCN0345Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521762541), received between Jul 13, 2020 and Jul 13, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC VENTRAL INCISIONAL HERNIA REPAIR, THREE SUTURES BROKE OFF FROM THE SUTURE. THE FIRST NEEDLE DETACHED FROM THE NEEDLE UPON INSERTION THROUGH THE TROCAR. THE SECOND NEEDLE DETACHED AGAIN. THE THIRD NEEDLE, THE SURGEON DID NOT WANT IT STRETCHED. ON THE FOURTH NEEDLE, IT WAS PLACED IN TROCAR CAREFULLY AND THE NEEDLE WAS NOT STRETCHED. THEY CONTINUED USING THE NEW SUTURES UNTIL IT WORKED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10264846 ↗