da Vinci EnergyRecalls & reported problems across all models

We found 3 models of da Vinci Energy by Intuitive Surgical, Inc. in the FDA's device registry (GUDID). Together they are named in 511 adverse event reports in the FDA's MAUDE database, received between Apr 9, 2020 and Sep 29, 2026 — classified as 3 deaths, 129 injuries, 378 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (86 reports).

2 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

da Vinci Energy recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 22, 2022Completed

   Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.

   Z-1484-2022 · Root cause: Process design · Recall details · FDA record ↗

2. Mar 3, 2022Completed

   Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.

   Z-1210-2022 · Root cause: Use error · Recall details · FDA record ↗

Most reported da Vinci Energy problems

da Vinci Energy models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• da Vinci Energy 480440

  System, surgical, computer controlled instrument
  1 recall2 deaths493 reports
• da Vinci Energy 378848

  System, surgical, computer controlled instrument
  1 recall3 reports
• da Vinci Energy 480522

  System, surgical, computer controlled instrument
  1 death15 reports

Recent da Vinci Energy adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 25, 2026Material Fragmentation; Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905857 ↗
• MalfunctionSep 24, 2026No Device Output; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890908 ↗
• MalfunctionSep 3, 2026Failure to Seal

  Refer to H11 for Follow-Up information.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50593223 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that after a da Vinci-assisted pancreatoduodenectomy procedure, the patient developed hemorrhagic shock secondary to postoperative bleeding, which required reoperation. The source and cause of the bleeding remain unclear. A SynchroSeal instrument was used during the procedure; however, the surgeon reported no intraoperative complications. The patient recovered and was discharged home. Additional information has been requested; however, no response has been received.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Shock

  MAUDE report 50473373 ↗
• MalfunctionAug 12, 2026Unintended System Motion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225395 ↗
• InjuryAug 11, 2026Break; Material Fragmentation

  It was reported that during a da Vinci assisted surgical procedure, a white plastic tip (fragment) broke from the Synchroseal instrument and fell into the patient. A fragment fell into the patient and was retrieved during the same procedure. Post operative X-ray has been performed to confirm the complete retrieval of the fragment. The procedure was completed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201503 ↗
• MalfunctionAug 7, 2026No Device Output; Failure to Seal

  It was reported that during a da Vinci-assisted surgical procedure, a Syncroseal had recognition issues. The procedure was completing as planned with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50184440 ↗
• 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 ↗
• MalfunctionMay 23, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT DID NOT REGISTER IN THE DAVINCI ARM. THE SYNCHROSEAL WAS REMOVED AND REINSERTED WITH POOR EFFECT. IT WAS REMOVED AND A BACKUP WAS OPENED WHICH WORKED WELL. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 25263455 ↗
• MalfunctionMay 22, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, CUSTOMER REPORTED THE 8MM SYNCHROSEAL FAILED DURING OPERATION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS FUNCTIONING NORMALLY AT THE START OF THE OPERATION, BUT AT A CERTAIN POINT IT STOPPED WORKING AND COULD NEITHER SEAL NOR CUT. THE SURGICAL TEAM REPORTED NO ACOUSTIC OR VISUAL FEEDBACK. THE PROBLEM WAS RESOLVED BY SWITCHING TO ANOTHER SYNCHROSEAL INSTRUMENT.

  Patient problems: Insufficient Information

  MAUDE report 25262582 ↗
• MalfunctionMay 21, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HIATAL HERNIA PARAESOPHAGEAL SURGICAL PROCEDURE, A PIECE OF THE CLAMP AT THE LEVEL OF ONE OF THE TWO JAWS BROKE OFF. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25238087 ↗

Other Intuitive Surgical, Inc. products

• EndoWrist62 models · 69,753 reports · 48 recalls
• daVinci Xi4 models · 11,477 reports · 3 recalls
• EndoWrist;daVinci Si35 models · 1,683 reports · 8 recalls
• daVinci 53 models · 1,608 reports · 5 recalls
• da Vinci Surgical System9 models · 1,459 reports · 5 recalls
• Ion6 models · 1,367 reports · 3 recalls
• SureForm16 models · 1,190 reports · 3 recalls
• EndoWrist SP20 models · 993 reports · 1 recall