da Vinci Energy 480522Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00886874123362), received between Jan 8, 2026 and Sep 29, 2026 — classified as 1 death, 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Failure to Seal” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break; Failure to Seal

  It was reported that the sealing was not completed when using a Vessel Sealer Curved instrument. No known impact or patient consequence was reported.

  Patient problems: Insufficient Information

  MAUDE report 50927510 ↗
• MalfunctionSep 29, 2026Difficult to Open or Close

  It was reported that during a da Vinci-assisted surgical procedure, the Vessel Sealer Curved instrument jaws would not open. The procedure was completed. No known impact or patient consequence was reported.Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained the following additional information: There was no injury to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927498 ↗
• MalfunctionSep 28, 2026Difficult to Open or Close

  It was reported that during a da Vinci-assisted surgical procedure, the Vessel Sealer Curved instrument jaws would not open. The procedure was completed. No known impact or patient consequence was reported.ISI followed up with the initial reporter and obtained the following additional information: There was no injury to the patient. The instrument was returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924010 ↗
• MalfunctionAug 12, 2026Unintended System Motion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225395 ↗
• InjuryAug 5, 2026Thermal Decomposition of Device; Therapy Delivered to Incorrect Body Area

  It was reported that after a da Vinci-assisted benign hysterectomy surgical procedure, the patient sustained a right ureter leak 5-7 days post operatively. Although the occurrence of an injury was not visualized during the initial procedure, the surgeon believes the elbow of the Vessel Sealer Curved (VSC) Instrument had a delayed thermal injury to the right ureter due to thermal spread. After the initial procedure, cystoscopy was performed to assess the ureteral jets and they were fine. The surgeon reports that the patient's anatomy was very challenging, the uterus contained fibroids that were extremely large like a volleyball. Due to the large uterus, the surgeon did not have a lot of clearance between the ureter and the bowel so the elbow of the VSC was pressed up against and hitting the patient's sidewall frequently while sealing vessels. As a result of the leak, the patient required a nephrostomy tube and pelvic drain. The surgeon plans for ureteral reimplantation after about 6 to 7 weeks.

  Patient problems: Burn(s)

  MAUDE report 50141528 ↗
• OtherAug 5, 2026Thermal Decomposition of Device; Therapy Delivered to Incorrect Body Area

  It was reported that during a da Vinci-assisted benign hysterectomy surgical procedure, the Vessel Sealer Curved instrument was hot and blanched the urachus while sealing the round ligament. The surgeon did not perform any interventions and reported it as minor non-consequential thermal spread. The procedure was completed as planned. After the procedure, cystoscopy was performed to assess ureteral jets and they were fine.

  Patient problems: Burn(s)

  MAUDE report 50141443 ↗
• DeathApr 23, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MEDIAN ARCUATE LIGAMENT SYNDROME RELEASE (MALS) PROCEDURE, THE PATIENT EXPERIENCED INTRAOPERATIVE BLEEDING FROM THE AORTA AND ULTIMATELY EXPIRED. THE VESSEL SEALER CURVED (VSC) INSTRUMENT WAS BEING USED FOR BLUNT DISSECTION AND CAUTERY WHEN SIGNIFICANT BLEEDING OCCURRED FROM THE AORTA. THE PROCEDURE WAS EMERGENTLY CONVERTED TO AN OPEN APPROACH. WHEN AN ASSISTING VASCULAR SURGEON CROSS CLAMPED THE AORTA DURING REPAIR ATTEMPTS, THE PATIENT¿S PULSE WAS LOST AND CHEST COMPRESSIONS WERE STARTED. WITH NO RETURN OF A PULSE, THE CROSS CLAMPS ON THE AORTA WERE REMOVED AND BLEEDING CONTINUED WITH THE CHEST COMPRESSIONS. THE PATIENT EXPIRED IN THE OPERATING ROOM. THE SURGEON STATED THAT THE CAUSE OF THE AORTIC INJURY WAS UNKNOWN. THE SURGEON REPORTED THAT THROUGHOUT THE PROCEDURE, IT WAS NOTICED THAT THE VSC PRODUCED INCREASED THERMAL SPREAD AND INCREASED BLEEDING AFTER ENERGY ACTIVATION WHEN COMPARED TO THE VESSEL SEALER EXTEND. IT WAS ALSO STATED THAT THE VSC JAW MOVEMENT WOULD OPEN A LITTLE SLOWLY AT FIRST, THEN WOULD SPRING OPEN QUICKLY, WITH INCREASED BLEEDING FROM THE FAST JAW OPENING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Great Vessel Perforation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24961585 ↗
• MalfunctionApr 20, 2026No Apparent Adverse Event

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24928075 ↗
• InjuryMar 14, 2026Entrapment of Device

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24600315 ↗
• MalfunctionMar 11, 2026No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CURVED VESSEL SEALER INSTRUMENT HAD AN ERROR MESSAGE OF ¿RE-INSTALL INSTRUMENT, IF ISSUE PERSISTS, DISCARD INSTRUMENT¿ THAT CAME UP MULTIPLE TIMES. THE CUSTOMER ENDED UP OPENING A NEW INSTRUMENT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571561 ↗
• MalfunctionMar 2, 2026Failure to Seal

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER WAS NOT GETTING HEMOSTASIS WHEN USING A CURVED VESSEL SEALER INSTRUMENT. THE CUSTOMER INQUIRED ON WHERE TO PLUG IN THE INSTRUMENT ON THE DV5 SYSTEM. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) INFORMED THE CUSTOMER THAT THEY NEEDED TO CONNECT THE INSTRUMENT TO THE E-200 GENERATOR. THE CUSTOMER CONFIRMED THAT THE INSTRUMENT WAS PLUGGED INTO THE LOWER BIPOLAR PORT. THE TSE RECOMMENDED TO TRY THE TOP BIPOLAR PORT OR A NEW INSTRUMENT. THE TSE INFORMED THE CUSTOMER THAT THEY COULD CONNECT THE BACKUP E-200 IF THE ISSUE CONTINUED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491574 ↗
• InjuryFeb 17, 2026Failure to Deliver Energy; Failure to Seal

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POSTOPERATIVE BLEEDING AND REQUIRED AN ANGIOGRAM. THE INITIAL ROBOTIC PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. THERE WAS NO EXCESSIVE INTRAOPERATIVE BLEEDING NOTED. THE VESSEL SEALER CURVED INSTRUMENT WAS USED ON THE DORSAL PANCREATIC ARTERY, WHERE THE BLEEDING WAS IDENTIFIED POSTOPERATIVELY. THE VESSEL WAS APPROXIMATELY 2MM IN DIAMETER. THE BLEEDING WAS CONTROLLED BY THE ANGIOGRAM; NO FURTHER INTERVENTION WAS REQUIRED, AND THE PATIENT DID NOT HAVE TO BE TAKEN BACK TO THE OPERATING ROOM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24367692 ↗
• InjuryFeb 17, 2026Failure to Deliver Energy; Failure to Seal

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POSTOPERATIVE BLEEDING AND REQUIRED AN ANGIOGRAM. THE INITIAL ROBOTIC PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. THERE WAS NO EXCESSIVE INTRAOPERATIVE BLEEDING NOTED. THE VESSEL SEALER CURVED INSTRUMENT WAS USED ON THE INFERIOR PANCREATIC DUODENAL BRANCH OFF THE SUPERIOR MESENTERIC ARTERY, WHERE THE BLEEDING WAS IDENTIFIED POSTOPERATIVELY. THE VESSEL WAS APPROXIMATELY 2MM IN DIAMETER. THE BLEEDING WAS CONTROLLED BY THE ANGIOGRAM; NO FURTHER INTERVENTION WAS REQUIRED, AND THE PATIENT DID NOT HAVE TO BE TAKEN BACK TO THE OPERATING ROOM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24366552 ↗
• MalfunctionJan 13, 2026Difficult to Open or Close

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24062152 ↗
• MalfunctionJan 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON WAS USING A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TO MANIPULATE THE TISSUE. WHILE DOING SO, THE SURGEON ACCIDENTLY HOOKED THE CAUTERY WIRE OF THE CURVED VESSEL SEALER INSTRUMENT WITH THE JAWS OF MCS INSTRUMENT AND PULLED IT OUT OF PLACE. THE CURVED VESSEL SEALER INSTRUMENT WAS NOT IN CONTACT WITH TISSUE AT THE TIME, AND THE SURGEON NOTICED A SNAGGED CAUTERY WIRE. THE PROCEDURE WAS PAUSED AND THE CURVED VESSEL SEALER INSTRUMENT WAS REPLACED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24007052 ↗