V-Loc VLOCN0605Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10884521171077), received between Jun 26, 2017 and Dec 26, 2025 — classified as 8 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2025Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, BEFORE OPENING AND REMOVING THE SUTURE FROM THE PACKAGING, THE SUTURE WAS DAMAGED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896751 ↗
• MalfunctionNov 25, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A ROBOTIC-ASSISTED LAPAROSCOPIC VENTRAL HERNIA REPAIR, THE DEVICE BROKE AT THE STRING WHILE BEING USED ON THE PATIENT. ANOTHER DEVICE WAS TAKEN FROM THE SAME BOX, AND THE STRING BROKE AGAIN. A THIRD DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23642611 ↗
• MalfunctionNov 25, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A ROBOTIC-ASSISTED LAPAROSCOPIC VENTRAL HERNIA REPAIR, THE DEVICE BROKE AT THE STRING WHILE BEING USED ON THE PATIENT. ANOTHER DEVICE WAS TAKEN FROM THE SAME BOX, AND THE STRING BROKE AGAIN. A THIRD DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23642603 ↗
• MalfunctionOct 30, 2025Break

  WOUND CLOSURE DEVICE BROKE ON THE STRING WHILE BEING USED ON THE PATIENT. ANOTHER DEVICE WAS TAKEN OUT OF THE SAME BOX AND THE STRING BROKE AGAIN. A 3RD DEVICE WAS TAKEN OUT AND NO FURTHER INCIDENT OCCURRED UNTIL THE PROCEDURE WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424766 ↗
• MalfunctionApr 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLORECTAL PROCEDURE, WHEN SEWING THE ANASTOMOSIS, AS THE DOCTOR WAS PULLING THE SUTURE THROUGH THE BOWEL BY THE NEEDLE, THE NEEDLE POPPED OFF FOR BOTH DEVICE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169821 ↗
• MalfunctionApr 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLORECTAL PROCEDURE, WHEN SEWING THE ANASTOMOSIS, AS THE DOCTOR WAS PULLING THE SUTURE THROUGH THE BOWEL BY THE NEEDLE, THE NEEDLE POPPED OFF FOR BOTH DEVICE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169818 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Packaging Problem; Adverse Event Without Identified Device or Use Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A MYOMECTOMY PROCEDURE, THE ABSORBABLE SUTURE WAS SIMILAR IN PACKAGING, COLOR, AND NUMBERS TO PERMANENT SUTURE, WHICH LED TO THE INADVERTENT USE OF THE PERMANENT SUTURE. THE PATIENT REQUIRED REMOVAL OF THE SUTURE FROM THE VAGINAL CUFF DUE TO PAIN DURING INTERCOURSE.

  Patient problems: Pain

  MAUDE report 18758352 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Packaging Problem; Adverse Event Without Identified Device or Use Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A HYSTERECTOMY PROCEDURE, THE ABSORBABLE SUTURE WAS SIMILAR IN PACKAGING, COLOR, AND NUMBERS TO PE RMANENT SUTURE, WHICH LED TO THE INADVERTENT USE OF THE PERMANENT SUTURE. THE PATIENT REQUIRED REMOVAL OF THE SUTURE FROM THE VAGINAL CUFF DUE TO PAIN DURING INTERCOURSE.

  Patient problems: Pain

  MAUDE report 18753924 ↗
• MalfunctionAug 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE IN A PROCEDURE, WHEN THE TECHNICIAN WAS REMOVING THE DEVICE FROM THE STERILE PACK, THE SUTURE STRING EASILY CAME OUT OF NEEDLE WHERE IT SHOULD HAVE BEEN SWEDGED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17444777 ↗
• MalfunctionJun 21, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, WHEN THE SUTURE WAS LOADED IN THE NEEDLE DRIVER TO CLOSE THE SWAGE AND CLAMPED TO TIGHT, THE TWO SUTURES BROKE. A THIRD SUTURE WAS USED WITH NO ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17171473 ↗
• InjuryNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHEN A VAGINAL VAULT CLOSURE WAS PERFORMED USING A NO N-ABSORBABLE SUTURE, IT WAS REPORTED THAT THE NON-ABSORBABLE SUTURE WAS NOT DEFECTIVE. THE SURGEON WAS NOTIFIED THAT THE PROCUREMENT HAD CHANGED THE ORDERING CODE; A NON-ABSORBABLE SUTURE WAS ORDERED INSTEAD OF THE INTENDED ABSORBABLE SUTURE. THE THEATER STAFF DID NOT NOTICE THE CHANGE IN CODE AND BOX AND USED THE NON-ABSORBABLE SUTURE FOR VAGINAL VAULT CLOSURE WHEN THE SURGEON USUALLY USED AN ABSORBABLE SUTURE. THE PACKAGING OF THE NON-ABSORBABLE AND ABSORBABLE SUTURE WAS SIMILAR. THE PATIENT HAD TO GO BACK INTO SURGERY AND THE SURGEON TRIMMED THE ABSORBABLE SUTURE AND MONITORED THE PATIENT. IT WAS NOTED THAT THE PATIENT EXTENDED HOSPITALIZATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15857226 ↗
• InjuryNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHEN A VAGINAL VAULT CLOSURE WAS PERFORMED USING A NO N-ABSORBABLE SUTURE, IT WAS REPORTED THAT THE NON-ABSORBABLE SUTURE WAS NOT DEFECTIVE. THE SURGEON WAS NOTIFIED THAT THE PROCUREMENT HAD CHANGED THE ORDERING CODE; A NON-ABSORBABLE SUTURE WAS ORDERED INSTEAD OF THE INTENDED ABSORBABLE SUTURE. THE THEATER STAFF DID NOT NOTICE THE CHANGE IN CODE AND BOX AND USED THE NON-ABSORBABLE SUTURE FOR VAGINAL VAULT CLOSURE WHEN THE SURGEON USUALLY USED AN ABSORBABLE SUTURE. THE PACKAGING OF THE NON-ABSORBABLE AND ABSORBABLE SUTURE WAS SIMILAR. ONE PATIENT HAS GONE TO ANOTHER HOSPITAL AND HAD THE NON-ABSORBABLE SUTURE LAPAROSCOPICALLY REMOVED BY ANOTHER SURGEON. IT WAS NOTED THAT THE PATIENT EXTENDED HOSPITALIZATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15857172 ↗
• InjuryNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHEN A VAGINAL VAULT CLOSURE WAS PERFORMED USING A NO N-ABSORBABLE SUTURE, IT WAS REPORTED THAT THE NON-ABSORBABLE SUTURE WAS NOT DEFECTIVE. THE SURGEON WAS NOTIFIED THAT THE PROCUREMENT HAD CHANGED THE ORDERING CODE; A NON-ABSORBABLE SUTURE WAS ORDERED INSTEAD OF THE INTENDED ABSORBABLE SUTURE. THE THEATER STAFF DID NOT NOTICE THE CHANGE IN CODE AND BOX AND USED THE NON-ABSORBABLE SUTURE FOR VAGINAL VAULT CLOSURE WHEN THE SURGEON USUALLY USED AN ABSORBABLE SUTURE. THE PACKAGING OF THE NON-ABSORBABLE AND ABSORBABLE SUTURE WAS SIMILAR. THE PATIENT HAD TO GO BACK INTO SURGERY AND THE SURGEON TRIMMED THE ABSORBABLE SUTURE AND MONITORED THE PATIENT. IT WAS NOTED THAT THE PATIENT EXTENDED HOSPITALIZATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15856964 ↗
• MalfunctionOct 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ESOPHAGEAL RESECTION, WHEN ESOPHAGEAL HIATUS WAS SUTURED, THE NEEDLE CAME OFF THE SUTURE. A NEW DEVICE WAS USED TO RESOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15546970 ↗
• MalfunctionApr 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TRANSABDOMINAL PREPERITONEAL HERNIA, WHILE THE SURGEON WAS DOING A RUNNING SUTURE WITH VLOC, THE NEEDLE OF THREE SUTURES DETACHED FROM THE THREAD. THE SURGEON OPENED A NEW BOX AND USED TWO SUTURES TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14233733 ↗
• MalfunctionApr 5, 2022Unraveled Material; Use of Device Problem; Unraveled Material; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING A DIGESTIVE SURGERY, WHILE CLOSING THE MESANTERIC WINDOW, THE THREAD WAS NOT TIGHT, MOREOVER, AT THE TIME OF CUTTING THE LATTER, IT CAME COMPLETELY UNDONE. TO RESOLVE THE ISSUE, THE SURGEON USED ANOTHER SUTURE WITHOUT ANY ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14016187 ↗
• MalfunctionJan 25, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC HERNIA REPAIR, WHILE CLOSING THE DEFECT AND SECURING THE HERNIA MESH . A TOTAL OF THREE SUTURE THREADS SNAPPED AFTER TWO TO THREE PASSES THROUGH THE TISSUE WHILE USING NORMAL RUNNING STITCH. THE SURGEON REMOVED THE BROKEN PIECES OF THREAD AND USED A NEW SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13351721 ↗
• MalfunctionMay 24, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A CLOSURE OF THE DEFECT ON A LAPAROSCOPIC INCISIONAL HERNIA REPAIR, THE THREAD BROKE INTO TWO. THE SAME EVENT OCCURRED TWICE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11870362 ↗
• InjuryJun 25, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC BYPASS PROCEDURE, WHILE CLOSING THE MESENTERIC BREACH, THE DEVICE NEEDLE BROKE AND FELL INTO THE PATIENT CAVITY. TO RESOLVE THE ISSUE, THE SURGEON HAD TO PERFORM AN X-RAY TO LOCATE THE NEEDLE AND TO BE ABLE TO RETRIEVE IT. THE PROCEDURE WAS ALSO CONVERTED FROM LAPAROSCOPIC TO AN OPEN PROCEDURE DUE TO THE PROBLEM. THE SURGICAL TIME WAS ALSO EXTENDED FOR MORE THAN 30 MINUTES, AND THERE WAS AN EXTENDED INCISION FOR MORE THAN 1 INCH OR 2.54 CM. THE PATIENT HAD A PERMANENT TISSUE DAMAGE.

  Patient problems: No Code Available; Radiation Exposure, Unintended; Tissue Damage

  MAUDE report 10196886 ↗
• InjuryDec 12, 2019Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, POST-OPERATIVELY ON AN EXTENDED LAPAROSCOPIC BOWEL RESECTION PROCEDURE, PATIENT HAD A LEAK AND THE SURGEON WENT BACK IN TO SEE WHY AND NOTICED THAT THE SUTURE HAD COMPLETELY DETACHED FROM THE TISSUE. THE SURGEON HAD TO PERFORMED ADDITIONAL OPERATION TO RESOLVE THE PROBLEM. DUE TO THE PROBLEM THE PATIENT EXTENDED HOSPITAL STAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9457830 ↗
• MalfunctionMay 23, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ROBOTIC VENTRAL HERNIA REPAIR PROCEDURE, THE DEVICE THREAD BROKE. THEY THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8636089 ↗
• MalfunctionFeb 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC HERNIA, WHILE BRINGING THE SUTURE TO THE TROCAR TO CLOSE THE DEFECT, THE NEEDLE BROKE OFF OF THE THREAD AT THE SWAGE. THE DID NOT FELL INTO THE PATIENT ABDOMEN BUT FELL ONTO THE GROUND. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8353423 ↗
• MalfunctionFeb 19, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HERNIA, WHILE CLOSING THE DEFECT, THE THREAD BROKE WHEN PULLING ON THE SUTURE AFTER THE SECOND STITCH. NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8352111 ↗
• MalfunctionSep 25, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN THE SUTURE WAS BEING PLACED THROUGH THE PORT DURING A LAPAROSCOPIC COLORECTAL PROCEDURE, THE NEEDLE DETACHED. NEEDLE HOLDER WAS HELD ON THE SUTURE BODY, HOWEVER, WHEN THEY MANEUVERING THROUGH THE PORT THE NEEDLE DISLODGED AND FELL STRAIGHT THROUGH THE PORT INTO THE PATIENT, YET THEY MANAGED TO RETRIEVE. THEY USED NEW SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7905699 ↗
• InjuryJun 26, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC UMBILICAL HERNIA REPAIR, THE DEVICE NEEDLE BROKE OFF AND FELL INTO THE PATIENT CAVITY. THE PORTION OF THE NEEDLE WAS RETRIEVED WITH THE AID OF AN X-RAY. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES AND THERE WAS NON-PERMANENT TISSUE DAMAGE OF THE ABDOMINAL MUSCLES DUE TO SEARCHING FOR THE DISENGAGED NEEDLE. THE CURRENT STATUS OF THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Radiation Exposure, Unintended; Tissue Damage

  MAUDE report 6666966 ↗