1 Uni Pdo 30cm VLP-2015Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00848782020867), received between Feb 18, 2021 and Jul 14, 2021 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2021Inadequacy of Device Shape and/or Size

  A QUILL VLP-2015(LOT AAFS597) WAS USED FOR A LAP MYOMECTOMY. THE SURGEON REPORTED THAT THE BARBS WERE TOO SMALL AND THE TRACTION FOR HOLDING IS NOT GOOD. SHE HAD TO GO BACK TO VLOC TO SECURE HAEMOSTASIS. THERE WAS STILL HAEMATOMA AFTER FINISHING SUTURING. THE OPERATION WAS DELAYED BY A LOT OF TIME AS THEY NEEDED TO RESUTURE WITH ANOTHER DEVICE.

  Patient problems: Hematoma

  MAUDE report 12170973 ↗
• MalfunctionJun 9, 2021Detachment of Device or Device Component; Device Fell

  THE NEEDLE DETACHED FROM THE SUTURE AND FELL INTO THE ABDOMINAL CAVITY OF THE PATIENT DURING A LAPAROSCOPIC MIOMECTOMY PROCEDURE. THE ENTIRE DEVICE WAS RETRIEVED AND REMOVED FROM THE SURGICAL FIELD WITHOUT FURTHER INCIDENT. PROLONGED SURGICAL TIME WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11971475 ↗
• MalfunctionFeb 18, 2021Break

  THE NEEDLE TIP BROKE OFF OF THE DEVICE DURING A ROBOTIC ASSISTED RADICAL PROSTATECTOMY RARP PROCEDURE. THE TIP WAS FLUSHED FROM THE SITE; NEEDLE WAS COMPLETELY ACCOUNTED FOR AND REMOVED FROM THE SITE WITHOUT FURTHER INCIDENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11342765 ↗