VELYS 4515-70-102Recalls & reported problems

Summary

The FDA's MAUDE database contains 263 adverse event reports that list this exact device (DI 10603295519430), received between Jan 28, 2022 and Sep 25, 2026 — classified as 2 injuries, 261 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (86 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 263 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Leak/Splash

  It was reported that during set up for a Total Knee Arthroplasty (TKA) surgery, the Robotic-Assisted Solution Saw Handpiece was leaking oil. A different saw handpiece was used during the surgery. Patient treatments were not delayed or cancelled. There was no patient involvement. The device was operated in conjunction with the Robotic-Assisted Solution Base Station device and the Robotic-Assisted Solution Satellite Station device. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50901441 ↗
• MalfunctionSep 25, 2026Device Slipped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900824 ↗
• MalfunctionSep 17, 2026Electrical /Electronic Property Problem; Device Slipped

  It was reported that prior to surgery, the VELYS SAW HANDPIECE device rotated. The handpiece could not be calibrated anymore.This event did not occur during surgery. There was no delay to the procedure. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809411 ↗
• MalfunctionSep 15, 2026Difficult or Delayed Separation; Premature Separation

  It was reported that during a Total Knee Arthroplasty (TKA) surgery during a femoral incision, the cable from the VELYS SAW HANDPIECE device was having connection issues to the VELYS SAW INTERFACE LEFT device. The device could be connected by targeted pressure. The robot was not mounted to the bed. The user troubleshooted the device by connecting cables. The left side was the affected side. The device was in use with the VELYS SATELLITE STATION device. There was no delay in the procedure reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774428 ↗
• MalfunctionSep 15, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773679 ↗
• MalfunctionSep 15, 2026Leak/Splash

  This is report 2 of 2 of (b)(4)It was reported that prior to a surgery procedure, the VELYS SAW HANDPIECE device was leaking a fluid by the saw blade. This event did not occur during surgery. There was delay to the surgical procedure. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773675 ↗
• MalfunctionSep 14, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763520 ↗
• MalfunctionSep 14, 2026Device Reprocessing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50757495 ↗
• MalfunctionSep 14, 2026Leak/Splash

  It was reported that preoperatively to an unknown procedure, it was observed that the Robotic-Assisted Solution Saw Handpiece device had an oil leakage problem. It was reported that there were no delays in the surgical procedure. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2026. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755232 ↗
• MalfunctionSep 14, 2026Device Slipped; Intermittent Loss of Power

  It was reported that the Robotic Assisted Saw Handpiece device was cutting out during first distal cut and the saw moved. During confirmation of the final legal alignment, the graph was completely off although the surgeon confirmed the leg was balanced. The issue occurred throughout the case. It was reported that the robot was mounted to the bed. There were no reports of injuries, medical intervention or prolonged hospitalization. No patient treatments were delayed or cancelled. All information has been disclosed. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753849 ↗
• MalfunctionSep 14, 2026Device Slipped; Intermittent Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753844 ↗
• MalfunctionAug 26, 2026Device Slipped; Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459357 ↗
• MalfunctionAug 19, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50325184 ↗
• MalfunctionMay 12, 2026Device Slipped; Complete Loss of Power

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA), WHEN USING A ROBOTIC ASSISTED SAW HANDPIECE DEVICE, ROBOTIC ASSISTED SATELLITE STATION DEVICE, AND THE ROBOTIC ASSISTED BASE STATION DEVICE, THE SYSTEM COULD SEE ALL OF THE ARRAYS AND THE GREEN LIGHTS WERE ILLUMINATED AS IF THE SYSTEM WAS READY TO CUT, HOWEVER, WHILE ATTEMPTING TO MAKE THE FIRST CUT, WHEN THE SURGEON PULLED THE SAW HAND PIECE TRIGGER THE SAW JUST "WIGGLED" A BIT BUT WOULD NOT CUT. IT WAS REPORTED THAT AFTER THE SYSTEM WAS REBOOTED AND THE DEVICES WERE REREGISTERED, THE ISSUE WAS RESOLVED. IT WAS REPORTED THAT THE ROBOT WAS NOT MOUNTED TO THE SURGICAL BED AS IT WAS CART MOUNTED. IT WAS REPORTED THAT THERE WAS A 10-MINUTE DELAY IN THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149043 ↗
• MalfunctionMay 12, 2026Device Slipped; Complete Loss of Power

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA), WHEN USING A ROBOTIC ASSISTED SAW HANDPIECE DEVICE, ROBOTIC ASSISTED SATELLITE STATION DEVICE, AND THE ROBOTIC ASSISTED BASE STATION DEVICE, THE SYSTEM COULD SEE ALL OF THE ARRAYS AND THE GREEN LIGHTS WERE ILLUMINATED AS IF THE SYSTEM WAS READY TO CUT, HOWEVER, WHILE ATTEMPTING TO MAKE THE FIRST CUT, WHEN THE SURGEON PULLED THE SAW HAND PIECE TRIGGER THE SAW JUST "WIGGLED" A BIT BUT WOULD NOT CUT. IT WAS REPORTED THAT AFTER THE SYSTEM WAS REBOOTED AND THE DEVICES WERE REREGISTERED, THE ISSUE WAS RESOLVED. IT WAS REPORTED THAT THE ROBOT WAS NOT MOUNTED TO THE SURGICAL BED AS IT WAS CART MOUNTED. IT WAS REPORTED THAT THERE WAS A 10-MINUTE DELAY IN THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148992 ↗
• MalfunctionMar 30, 2026Material Frayed; Premature Separation

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE OF THE KNEE IT WAS OBSERVED THAT THE BLACK CORD ON THE ROBOTIC ASSISTED SAW HANDPIECE DEVICE WAS DAMAGED. IT WAS REPORTED THAT THE CORD WOULD NOT STAY PLUGGED INTO THE SAW INTERFACE DEVICE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24734317 ↗
• MalfunctionMar 30, 2026Device Alarm System; Unintended System Motion; Physical Resistance/Sticking; Intermittent Loss of Power

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE VELYS SAW HANDPIECE DEVICE AND THE VELYS SATELLITE STATION DEVICE, THE HANDLE ON BACK OF MACHINE RESPONSIBLE FOR LIFTING DEVICE UP AND DOWN WINDING ¿DOWN¿ WHEN ADJUSTED AND NOT HOLDING. WHEN DEVICE ARM WAS LOCKED WITH BLUE STAR KNOB, THE CENTER WAS ROTATING MEANING IT COULD NOT ADJUST TO THE PLANE AND KEPT ERRORING WHEN TRYING TO MOVE TO ANTERIOR CUT. THIS MEANT WE NEEDED TO ABANDON VELYS CASE AND MOVE TO INSTRUMENTATION USING VELDS CUTS. NO FRAGMENTS WERE GENERATED. THERE WAS A FOUR MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727955 ↗
• MalfunctionMar 11, 2026Premature Separation

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE VELYS SAW HANDPIECE DEVICE THE ANTERIOR CHAMFER CUT THE SAW ARRAY BECAME LOOSE AND SWUNG OFF. SURGEON THEN PUT IT BACK ON AND ALLOWED HIS FELLOW TO FINISH THE CUT. THE DEVICE WAS IN USE WITH THE VELYS BASE STATION DEVICE AND THE VELYS SATELLITE STATION DEVICE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570841 ↗
• MalfunctionMar 11, 2026Premature Separation

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA), THE LOCKING MECHANISM FOR SAW BLADE MALFUNCTIONED AND THE SAW BLADE CAME DETACHED FROM THE VELYS SAW HANDPIECE DURING USE. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE AS AN SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569456 ↗
• MalfunctionMar 3, 2026Device Reprocessing Problem

  IT WAS REPORTED THAT THE VELYS SAW HANDPIECE DEVICE WAS CONTAMINATED WITH OIL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498976 ↗
• MalfunctionMar 2, 2026Device Reprocessing Problem

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE VELYS SAW HANDPIECE DEVICE WAS LEAKING LIQUIDS. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS CONTAMINATED RELATING TO OIL. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24486264 ↗
• MalfunctionMar 2, 2026Device Reprocessing Problem

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE VELYS SAW HANDPIECE DEVICE WAS LEAKING LIQUIDS. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS CONTAMINATED RELATING TO OIL. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24486127 ↗
• MalfunctionFeb 27, 2026Device Reprocessing Problem

  WATER-LIKE SUBSTANCE WAS FOUND ON THE VELYS HAND PIECE AFTER BEING STERILIZED AND PROCESSED. ISSUE HAS BEEN REOCCURRING. ANOTHER HANDPIECE SET WAS OPENED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THREE MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472493 ↗
• MalfunctionFeb 24, 2026Device Alarm System; Electrical /Electronic Property Problem; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING EVALUATION OF THE DEVICE, IT WAS DETERMINED THAT THE ROBOTIC ASSISTED SAW HANDPIECE DEVICE WAS FOUND TO BE LOOSE AT THE CONNECTOR. IT WAS INITIALLY REPORTED THAT THE DEVICE HAD AN ERROR "SAW NOT CONNECTED". THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24432022 ↗
• MalfunctionFeb 20, 2026Device Reprocessing Problem; Leak/Splash

  IT WAS REPORTED THAT DURING EVALUATION OF THE RETURNED PHOTO OF THE ROBOTIC ASSISTED SAW HANDPIECE DEVICE, IT WAS DETERMINED THAT WAS LEAKING FLUID. IT WAS NOTED IN THE SERVICE ORDER THAT CLEAR FLUID FOUND ON THE DEVICE AFTER OPENING THE STERILE SET. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402388 ↗