V-Loc 90 VLOCM2115Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521133006), received between Nov 29, 2017 and Nov 21, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (14 reports).

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

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.

Recalls naming this device

1. Jun 24, 2026Open, Classified

   Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

   Z-2918-2026 · Root cause: Equipment maintenance · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC ROBOTIC VENTRAL HERNIA REPAIR, WHEN THE MESH WAS BEING SEWN, ONE SUTURE STRAND BROKE AT THE MIDDLE. A SECOND SUTURE FROM THE SAME LOT HAD ITS THREAD DETACHED FROM THE NEEDLE AT THE SWAGE. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23625014 ↗
• MalfunctionNov 21, 2025Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC ROBOTIC VENTRAL HERNIA REPAIR, WHEN THE MESH WAS BEING SEWN, ONE SUTURE STRAND BROKE AT THE MIDDLE. A SECOND SUTURE FROM THE SAME LOT HAD ITS THREAD DETACHED FROM THE NEEDLE AT THE SWAGE. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23625013 ↗
• MalfunctionOct 4, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC HYSTERECTOMY PROCEDURE, IN CUFF CLOSURE, THE SUTURE BROKE IN THE MIDDLE WHILE SUTURING. THIS ISSUE OCCURRED ON THREE DEVICES. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372416 ↗
• MalfunctionOct 4, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC HYSTERECTOMY PROCEDURE, IN CUFF CLOSURE, THE SUTURE BROKE IN THE MIDDLE WHILE SUTURING. THIS ISSUE OCCURRED ON THREE DEVICES. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372118 ↗
• MalfunctionOct 4, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC HYSTERECTOMY PROCEDURE, IN CUFF CLOSURE, THE SUTURE BROKE IN THE MIDDLE WHILE SUTURING. THIS ISSUE OCCURRED ON THREE DEVICES. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372087 ↗
• MalfunctionJul 23, 2024Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A ROBOTIC HYSTERECTOMY PROCEDURE, THE SUTURE SNAPPED WHILE SUTURING. THE SURGEON FINISHED IT WITH A KNOT.

  Patient problems: Insufficient Information

  MAUDE report 19806122 ↗
• MalfunctionJul 23, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHILE CLOSING THE VAGINAL CUFF, THE SUTURE BROKE. TO RESOLVE THE ISSUE, THE SURGEON JUST FINISHED IT BY TYING A KNOT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805931 ↗
• MalfunctionSep 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC HYSTERECTOMY, WHEN CLOSING THE VAGINAL CUFF, THE SUTURE POPPED OFF THE NEEDLE. ANOTHER SUTURE OF THE SAME TYPE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775768 ↗
• MalfunctionNov 10, 2022Break; Break

  ACCORDING TO THE REPORTER, ON A ROBOTIC LAPAROSCOPIC TRANSABDOMINAL RIGHT FLANK HERNIA REPAIR, WHILE SECURING THE INTRA-ABDOMINAL TISSUE. THE THREAD BROKE. THE THREAD SNAPPED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15775583 ↗
• MalfunctionJul 1, 2022Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, TWO SUTURES HAD BROKEN THREAD.

  Patient problems: Insufficient Information

  MAUDE report 14892585 ↗
• MalfunctionJul 1, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD BROKE.

  Patient problems: Insufficient Information

  MAUDE report 14892028 ↗
• MalfunctionJun 27, 2022Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE THREAD WAS SHREDDED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14837141 ↗
• MalfunctionApr 12, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC MYOMECTOMY, THE DEVICE'S THREAD BROKE. THE SURGEON THEN USED ANOTHER DEVICE 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 11648671 ↗
• MalfunctionMar 25, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING CLOSING POCKET ON AN OPEN PACEMAKER INSERTION, THE THREAD BROKE. ANOTHER SUTURE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11573076 ↗
• MalfunctionFeb 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC URACHUS RESECTION, WHILE PERFORMING THE CONTINUOUS SUTURING TECHNIQUE, THE DEVICE THREAD AND NEEDLE DISENGAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11303046 ↗
• MalfunctionJan 28, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC REPAIR SCARE FRACTURE PROCEDURE, 4 SUTURE THREADS BROKE. A NEW SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9636254 ↗
• MalfunctionJul 23, 2018Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOTIC VENTRAL REPAIR PROCEDURE, HALF WAY INTO THE PROCEDURE WHILE THE SURGEON WAS EMPLOYING A WHIP STITCH, WITH ALL THE THREE STRANDS, THE NEEDLE FELL OFF OF THE SUTURE AT THE "SWEDGE". SURGEON DESCRIBED IT AS THE SUTURE BASICALLY FALLING RIGHT OUT OF THE SWEDGE HOLE. ALL BEFORE BEING USED AT ALL. THE NEEDLE FELL INTO THE CAVITY AND WAS RETRIEVED BY THE SURGEON USING THE ROBOT. A NEW DEVICE WITH A DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7710271 ↗
• MalfunctionJul 23, 2018Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOTIC VENTRAL REPAIR PROCEDURE, HALF WAY INTO THE PROCEDURE WHILE THE SURGEON WAS EMPLOYING A WHIP STITCH, WITH ALL THE THREE STRANDS, THE NEEDLE FELL OFF OF THE SUTURE AT THE SWEDGE. SURGEON DESCRIBED IT AS THE SUTURE BASICALLY FALLING RIGHT OUT OF THE SWEDGE HOLE. ALL BEFORE BEING USED AT ALL. THE NEEDLE FELL INTO THE CAVITY AND WAS RETRIEVED BY THE SURGEON USING THE ROBOT. A NEW DEVICE WITH A DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7710077 ↗
• MalfunctionDec 12, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHEN THEY WERE PULLING THE SUTURE STRAND, THE THREAD BROKE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7107531 ↗
• MalfunctionNov 29, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHEN THEY WERE PULLING THE SUTURE STRAND, THE THREAD BROKE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7068690 ↗