V-Loc 90 VLOCM1904Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521132917), received between Nov 20, 2017 and Dec 8, 2025 — classified as 6 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (9 reports).

1 other recall cover devices cleared under the same FDA submission (K100257); 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.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Break; Break

  IT WAS REPORTED THAT DURING THE ROBOTIC PROSTATECTOMY, WHILE PERFORMING END ANASTOMOSIS WITH THE SUTURE, THE NEEDLE BROKE AND FELL INTO THE PATIENT CAVITY. THE NEEDLE WAS THEN RETRIEVED USING GRASPERS. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23752483 ↗
• InjuryMay 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROBOTIC PROSTATECTOMY, THE NEEDLE DETACHED AND BECAME LODGED IN THE PATIENT'S PERINEUM AND WAS UNABLE TO BE RETRIEVED, AS REMOVAL WOULD HAVE CAUSED MORE DAMAGE THAN LEAVING THE NEEDLE IN PLACE. IT WAS NOTED THAT AN X-RAY WAS USED TO IDENTIFY SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 22119939 ↗
• MalfunctionJan 20, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE ROBOTIC RIGHT PYELOPLASTY, THE THREE SUTURES BROKE WHILE TRYING TO SUTURE WITH THE ROBOT THE INSIDE OF THE PATIENT'S ABDOMEN, CAUSING A DELAY IN PATIENT CARE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191563 ↗
• MalfunctionJan 20, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE ROBOTIC RIGHT PYELOPLASTY, THE THREE SUTURES BROKE WHILE TRYING TO SUTURE THE INSIDE OF THE PATIENT'S ABDOMEN. THE SURGICAL TIME WAS EXTENDED BUT THE DELAY WAS NOT GREATER THAN 30 MINUTES. ADDITIONAL SUTURES WERE OPENED AND UTILIZED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191549 ↗
• MalfunctionJan 20, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE ROBOTIC RIGHT PYELOPLASTY, THE THREE SUTURES BROKE WHILE TRYING TO SUTURE WITH THE ROBOT THE INSIDE OF THE PATIENT'S ABDOMEN, CAUSING A DELAY IN PATIENT CARE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191503 ↗
• MalfunctionJun 28, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST OPERATIVELY OF A ROBOTIC LAPAROSCOPIC PROSTATECTOMY, ANASTOMOSIS WITH CONTINUOUS SUTURING TECHNIQUE, THE SUTURE DID NOT ABSORB PROPERLY. THE SURGEON HAD TO PUT THE CATHETER IN AGAIN FOR THIS PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: Failure to Anastomose; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19638622 ↗
• MalfunctionDec 28, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PACEMAKER PROCEDURE, WHILE THE SURGEON WAS CLOSING THE SUBCUTICULAR LAYER WITH MINIMAL PRESSURE, THE SUTURE BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18414602 ↗
• MalfunctionMay 2, 2023Component Missing; Component Missing

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE PACKAGE WAS OPENED, THERE WAS NO NEEDLE ATTACHED. ANOTHER PACK WAS OPENED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16853985 ↗
• InjuryMay 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON INSERTED THE NEEDLE INTO THE KIDNEY AND THE NEEDLE SEPARATED FROM THE THREAD. THE NEEDLE AND THREAD WERE REMOVED AND A SECOND SUTURE WAS HANDED TO THE SURGEON. THE SURGEON COMMENCED CLOSING THE DEFECT AND AFTER A FEW CONTINUOUS SUTURES, THE NEEDLE AFTER BEING INTRODUCED INTO THE KIDNEY, SEPARATED FROM THE THREAD AGAIN. THE SURGEON TOOK TIME TO LOCATE THE NEEDLE TO NO AVAIL. PRODUCT DEFECT RESULTED IN RADICAL NEPHRECTOMY. AFTER KIDNEY WAS REMOVED, KIDNEY WAS DISSECTED AND NEEDLE WAS INTACT. THE SALES REP WAS UNSURE WHICH TWO OF THE THREE PROVIDED LOT NUMBERS WERE ASSOCIATED WITH 2 NEEDLES THAT DETACHED FROM THREAD.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14275355 ↗
• InjuryMay 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON INSERTED THE NEEDLE INTO THE KIDNEY AND THE NEEDLE SEPARATED FROM THE THREAD. THE NEEDLE AND THREAD WERE REMOVED AND A SECOND SUTURE WAS HANDED TO THE SURGEON. THE SURGEON COMMENCED CLOSING THE DEFECT AND AFTER A FEW CONTINUOUS SUTURES, THE NEEDLE AFTER BEING INTRODUCED INTO THE KIDNEY, SEPARATED FROM THE THREAD AGAIN. THE SURGEON TOOK TIME TO LOCATE THE NEEDLE TO NO AVAIL. PRODUCT DEFECT RESULTED IN RADICAL NEPHRECTOMY. AFTER KIDNEY WAS REMOVED, KIDNEY WAS DISSECTED AND NEEDLE WAS INTACT. THE SALES REP WAS UNSURE WHICH TWO OF THE THREE PROVIDED LOT NUMBERS WERE ASSOCIATED WITH 2 NEEDLES THAT DETACHED FROM THREAD.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14273215 ↗
• InjuryMay 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON INSERTED THE NEEDLE INTO THE KIDNEY AND THE NEEDLE SEPARATED FROM THE THREAD. THE NEEDLE AND THREAD WERE REMOVED AND A SECOND SUTURE WAS HANDED TO THE SURGEON. THE SURGEON COMMENCED CLOSING THE DEFECT AND AFTER A FEW CONTINUOUS SUTURES, THE NEEDLE AFTER BEING INTRODUCED INTO THE KIDNEY, SEPARATED FROM THE THREAD AGAIN. THE SURGEON TOOK TIME TO LOCATE THE NEEDLE TO NO AVAIL. PRODUCT DEFECT RESULTED IN RADICAL NEPHRECTOMY. AFTER KIDNEY WAS REMOVED, KIDNEY WAS DISSECTED AND NEEDLE WAS INTACT. THE SALES REP WAS UNSURE WHICH TWO OF THE THREE PROVIDED LOT NUMBERS WERE ASSOCIATED WITH 2 NEEDLES THAT DETACHED FROM THREAD.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14273064 ↗
• MalfunctionJun 4, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A ROBOTIC-ASSISTED LAPAROSCOPIC PROSTATECTOMY, WHILE USING A CONTINUOUS SUTURING TECHNIQUE, THE NEEDLE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10121794 ↗
• InjuryMar 30, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC NEPHRECTOMY WHILE PERFORMING ANASTOMOSIS AS THE SURGEON WAS PULLING THE SUTURE, THE NEEDLE BROKE OFF FROM THE STRAND AND FELL INTO THE CAVITY. THE STAFF SPENT AN EXTRA HOUR SEARCHING FOR THE MISSING NEEDLE. AN X-RAY WAS DONE TO DETERMINE THE POSITIONING OF THE NEEDLE. FOLLOWING X-RAY, SURGEON DETERMINED IT WAS TOO RISKY TO REMOVE THE NEEDLE DUE TO THE POSITION. SURGEON ENDED CASE WITH A RETAINED NEEDLE.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 9896442 ↗
• MalfunctionApr 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PARTIAL NEPHRECTOMY PROCEDURE, WHILE PLACING THE SUTURE, THERE WERE FOUR NEEDLE WHICH CAME OFF WITH A VERY LITTLE FORCE. A NEEDLE FELL INTO THE PATIENT'S CAVITY BUT WAS RETRIEVED USING NEEDLE DRIVERS. A DIFFERENT SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8480097 ↗
• MalfunctionAug 31, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY, THE THREAD BROKE. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7837068 ↗
• InjuryDec 11, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE NEEDLE FELL INTO PATIENT'S ABDOMEN AND GOT STUCK IN THE PERITONEUM. DUE TO THE LOCATION OF THE NEEDLE, THE SURGEON DECIDED TO RETAIN IT INSIDE AND ALLOWED TO MIGRATE. SURGEON ORDERED AN X-RAY FOR THE PATIENT AND VERIFIED THE DEVICE RETAINED INSIDE.

  Patient problems: Foreign Body Reaction; No Consequences Or Impact To Patient; Radiation Exposure, Unintended

  MAUDE report 7105741 ↗
• MalfunctionDec 5, 2017Break; Split; Break; Split

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SUTURE SPLIT AND THE NEEDLE BROKE. THE PATIENT HAS NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7085829 ↗
• MalfunctionNov 20, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC PROCEDURE, AS SOON AS THEY INSERTED, THE SUTURE DETACHED FROM THE NEEDLE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7046338 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100257. One submission often covers many models, so check the product and lot details in each record.

• Z-2918-2026 · Jun 24, 2026 · Open, Classified
  V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VL