V-Loc 180 VLOCA308LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521068780), received between Mar 24, 2017 and Jun 4, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K111442); they may or may not involve this specific model.

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.

Recalls naming this device

1. Sep 28, 2022Class IIOpen, Classified

   Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign body reaction, allergic reaction, tissue injury and unintended radiation exposure from additional imaging for both intra-op and postoperative scenarios.

   Z-0200-2023 · Root cause: Process control · Recall details · FDA record ↗

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.

• MalfunctionJun 4, 2021Component or Accessory Incompatibility; Detachment of Device or Device Component; Human-Device Interface Problem; Component or Accessory Incompatibility; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE PROCEDURE, THE DEVICE WAS DIFFICULT TO TOGGLE AND LOAD AND THE NEEDLE BROKE OFF. THE NEEDLE FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED WITH GRASPERS. A NEW RELOAD WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11943011 ↗
• MalfunctionFeb 12, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE. THE SUTURING DEVICE WAS BEING USED WHILE CLOSING THE VAGINAL CUFF. THE NEEDLE SNAPPED IN HALF AFTER THE FIRST BITE OF THE CLOSURE. THE SURGEON HAD TOOK A DEEP BITE ON TISSUE AND GOT HOLD OF COLPOTOMIZER THICK EDGE. THE NEEDLE PIECES FELL INTO THE CAVITY OF THE PATIENT. IT TOOK A LOT OF TIME TO LOCATE THE OTHER HALF OF THE NEEDLE. AT THE END, BOTH PIECES OF THE NEEDLE WERE FOUND AND THE SURGEON CARRIED ON WITH THE PROCEDURE. THE SURGICAL TIME WAS EXTENDED BY THIRTY MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. THE INCISION WAS EXTENDED BY LESS THAN ONE INCH. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, USED ANOTHER NEEDLE RELOAD WITH THE ORIGINAL SUTURING DEVICE AND IT WORKED FINE. THE PATIENT OUTCOME IS REPORTED AS NO INJURY.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7264771 ↗
• MalfunctionMar 24, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC RECTOPEXY PROCEDURE. THE SUTURING DEVICE WAS BEING USED TO CLOSE THE PERITONEUM. THE NEEDLE RELOAD CAME OFF OF THE SUTURING DEVICE THREE TIMES. EACH TIME, HAD TO CUT THE PREVIOUS ONE AND START WITH A NEW RELOAD. NO DEVICE COMPONENT FELL INTO THE PATIENT'S CAVITY. THERE WERE NO ISSUES WITH TOGGLING, LOADING, OR UNLOADING THE DEVICE. THERE WAS NO PATIENT HARM. THE PATIENT STATUS IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6432144 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111442. One submission often covers many models, so check the product and lot details in each record.

• Z-0201-2023 · Sep 28, 2022 · Open, Classified
  Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L