da Vinci Energy 480440Recalls & reported problems

Summary

The FDA's MAUDE database contains 493 adverse event reports that list this exact device (DI 00886874117309), received between Apr 9, 2020 and Sep 25, 2026 — classified as 2 deaths, 124 injuries, 367 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (85 reports).

1 FDA recall record name this device's 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, 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.

Recalls naming this device

1. Mar 3, 2022Class IICompleted

   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 problems

Recent adverse event reports

The 25 most recent of 493 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMay 12, 2026Failure to Deliver Energy; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYNCHROSEAL WOULD NOT WORK. THE USER CONVERTED THE PROCEDURE TO LAPAROSCOPIC SURGERY WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE TEAM TRIED OPEN MORE NEW SUPPLIES DID NOT WORK AND SURGEON WISH CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY AND USED LIGASURE TO COMPLETE THE CASE ON TIME. THE PATIENT TOLERATED THE CONVERSION WITH NO INJURY REPORTED. THE INSTRUMENT DID NOT WORK AT ALL. THERE WAS NO AUDIBLE SOUND WHEN PRESSED AND NO TONES. THERE WAS NO SEALING AND NO CUTTING. THERE WAS NO BLEEDING OBSERVED. THERE WERE NO ERROR MESSAGES AND TECHNICAL SUPPORT FOUND NO ERROR MESSAGES IN THE LOGS. THERE ARE NO VIDEO RECORDINGS FOR ISI TO REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25151187 ↗
• MalfunctionMay 7, 2026Failure to Deliver Energy; Failure to Seal

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED WEDGE TO COMPLETION LOBECTOMY SURGICAL PROCEDURE, THE 8MM SYNCHROSEAL FAILED TO SEAL PROPERLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE FOLLOWED UP AND OBTAINED ADDITIONAL INFORMATION. PRODUCT WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES OR UNUSUAL FINDINGS. THE SURGEON USED THE INSTRUMENT FOR SEVERAL MINUTES WITHOUT ANY APPARENT ISSUES; HOWEVER, AFTER THAT PERIOD, THE INSTRUMENT CEASED TO PERFORM ITS INTENDED FUNCTION (IT DID NOT COAGULATE, SEAL, OR CUT ¿ ¿SYNC¿). THE INSTRUMENT FUNCTIONED FOR APPROXIMATELY 7 MINUTES. NO ERROR DISPLAYED. YES, A CONTINUOUS TONE WAS HEARD DURING THE SEALING ATTEMPT. NO, THE TONE INDICATING SUCCESSFUL COMPLETION OF THE SEALING CYCLE OR SYNC WAS NOT HEARD. YES, THE TISSUE WAS VISUALLY INSPECTED TO ASSESS THE EFFECT. NO, SINCE THE SEALING CYCLE WAS NOT COMPLETED, THE CUT FUNCTION WAS ALSO NOT COMPLETED. THE TARGET TISSUE WAS A LYMPH NODE. IT WAS NOT UNDER EXCESSIVE TENSION (ONLY STANDARD TRACTION REQUIRED FOR EFFECTIVE INSTRUMENT USE). THE TISSUE BETWEEN THE JAWS DID NOT EXCEED 5 MM IN DIAMETER. THERE WAS NO EVIDENCE OF CALCIFICATION, AND THE TISSUE HAD NOT BEEN EXPOSED TO RADIATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25119066 ↗
• InjuryMay 4, 2026Material Separation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE, A FRAGMENT FROM THE "COATING" OF A SYNCHROSEAL INSTRUMENT FELL INSIDE THE PATIENT'S BODY. THE FRAGMENT WAS NOT RETRIEVED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT WAS INSPECTED BEFORE USE AND FOUND TO BE NORMAL. DURING SURGERY, INTERFERENCE BETWEEN INSTRUMENTS ON ARM #3 AND ARM #4 CAUSED A DEVICE FRAGMENT TO FALL INSIDE THE PATIENT. THE SURGEON INDICATED THAT THE INSTRUMENT COLLISION WAS THE CAUSE OF THE EVENT AND WAS COMMITTED TO PREVENTING SUCH OCCURRENCES IN THE FUTURE. THE INSTRUMENT HAD BEEN USED FOR ABOUT 39 MINUTES WITHOUT FUNCTIONAL ISSUES NOTED DURING THE PROCEDURE. THE FRAGMENT FROM THE INSTRUMENT WAS FOUND POSTOPERATIVELY IN INFECTIOUS WASTE CONTAINING COAGULATED BLOOD THAT WAS ASPIRATED WITH A SUCTION TUBE. NO ADDITIONAL SURGICAL PROCEDURES OR POSTOPERATIVE TESTS WERE REQUIRED, AND THE OPERATION WAS COMPLETED ROBOTICALLY USING THE SAME INSTRUMENT. THERE WAS NO INJURY TO THE PATIENT AND NO SUBSEQUENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25074905 ↗
• MalfunctionMay 4, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25074379 ↗
• MalfunctionMay 1, 2026Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION SURGICAL PROCEDURE, THE 8MM SYNCHROSEAL INSTRUMENT STOPPED WORKING. THE INSTRUMENT WOULD NO LONGER BURN. CUSTOMER OPENED A NEW SYNCHROSEAL TO FINISH THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058651 ↗
• MalfunctionApr 29, 2026Thermal Decomposition of Device; Material Fragmentation; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY ¿ BENIGN SURGICAL PROCEDURE, THREE SYNCHRSEAL WITHIN ONE SURGERY WERE DEFECTIVE. AFTER ONE OR TWO USES, THE COATING IN THE JAWS CAME LOOSE AND THE DEVICE DISPLAYED AN ERROR MESSAGE. THE INSTRUMENT THEN BECAME UNUSABLE. REPEATED ERROR 25913 OCCURED MID PROCEDURE. THE NURSE REPLACED THE SYNCROSEAL INSTRUMENT WITH A BACKUP SYNCHROSEAL INSTRUMENT AND THE ERROR REOCCURRED. THE CLINICAL SALES REPRESENTATIVE (CSR) POWER CYCLED E-100 GENERATOR, THE ISSUE APPEARED TO OCCUR LESS BUT IT WAS STILL OCCURRING. THE THIRD SYNCHROSEAL INSTRUMENT THAT WAS USED HAD THE SAME ERROR OCCUR. THE ERROR MESSAGE DISPLAYED THAT HOMEOSTASIS WAS COMPROMISED AND THE SEALING PROCESS WAS NOT SUCCESSFUL. ERROR LOGS SHOW ERROR 25913 - E-100 ERROR: RECOVERABLE ERROR: INSTRUMENT CUT ELECTRODES SHORTED (P1:0X10000001) / REC-01. THE CSR STATED THE INSTRUMENT BRANCHES WERE NOT TOO DIRTY, NOT CARBONIZED. THE INSTRUMENT WAS CLEANED AND REINSERTED, BUT THE ERROR PERSISTED. AFTERWARDS, THE CSR STATED THAT THE PLASTIC ON THE SYNCHROSEAL INSTRUMENT APPEARED AS IF IT WAS LIQUIFIED AND/OR SOME PARTS WERE MISSING. AT THE TIME, IT WAS NOT CLEAR YET IF PARTS FELL INTO PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024513 ↗
• MalfunctionApr 29, 2026No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT TURNS OFF/FLASHES YELLOW ON THE TOWER RANDOMLY WHEN TRYING TO FIRE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 25024491 ↗
• InjuryApr 28, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT COMPLETELY DISINTEGRATED INTRAOPERATIVELY. THERE WAS A TOTAL OF 200 ML BLOOD LOSS. NO FRAGMENT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW INSTRUMENT. THE FOLLOWING INFORMATION IS UNKNOWN: DETAILS REGARDING THE DISINTEGRATION OF THE INSTRUMENT, THE CAUSE AND SOURCE OF THE BLEEDING, AND WHAT MEDICAL INTERVENTION (IF ANY) WAS RENDERED DUE TO THE COMPLICATION. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25020990 ↗
• MalfunctionApr 27, 2026Thermal Decomposition of Device; Material Fragmentation; Visual Prompts will not Clear

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009130 ↗
• MalfunctionApr 27, 2026Failure to Seal

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE SYNCHRO SEAL INSTRUMENT FAILED ON THE LAST THIRD OF THE PARENCHYMA PHASE. THE SURGEON REPORTED THAT IT WAS VERY DIFFICULT AND THEREFORE LONG-LASTING, HOWEVER, THIS WAS PRIMARILY DUE TO PATIENT-RELATED PECULIARITIES. UNFORTUNATELY, DESPITE CLEANING THE SYNCHROSEAL INSTRUMENT AGAIN AND AGAIN, THE SYNCHROSEAL WORKED AT MOST ONCE BUT COULD NEVER END THE YELLOW MODE. THE USER COMPLETED THE PROCEDURE AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER IS UNAWARE OF ANY ERRORS THAT OCCURRED DURING THE ISSUE WITH THE SYNCHROSEAL INSTRUMENT. AT THE TIME OF THE REPORTED ISSUE, DURING THE SEALING SEQUENCE, THERE WAS AN AUDIBLE ¿SEALING IN PROGRESS¿ TONE. THE SEAL CYCLE WAS NOT COMPLETED AUTOMATICALLY. THERE WAS NOT ANY TISSUE CUT THAT WAS NOT FULLY SEALED. THE CUSTOMER IS UNAWARE OF ANY BLEEDING OBSERVED DUE TO THE SYNCHROSEAL ISSUE. THE INSTRUMENT WAS DISPOSED AND IS NOT AVAILABLE FOR RETURN TO INTUITIVE SURGICAL FOR EVALUATION. THE CUSTOMER IS UNAWARE OF ANY PHOTOS AND

  Patient problems: Insufficient Information

  MAUDE report 24998394 ↗
• MalfunctionApr 21, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE SYNCHROSEAL DID NOT RESPOND TO COMMANDS. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. THERE WERE NO DELAYS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 27-NOV-2025: THE COMPLETE BATCH NUMBER OF THE SYNCHROSEAL IS 480440-06/K15241127 0359. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NOTHING OUT OF THE ORDINARY WAS NOTICED. THE ISSUE OCCURRED WHILE TRYING TO REACH THE VESSEL. THE ISSUE OCCURRED WITH THE SURGEON¿S HEAD INSIDE THE SURGEON CONSOLE¿S HIGH RESOLUTION STEREO VIEWER, WHILE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SURGEON SIDE CONSOLE (SSC). THE ISSUE WAS RELATED TO AN INABILITY TO MOVE THE INSTRUMENT AT ALL. THERE WAS NO INSTRUMENT-TO-INSTRUMENT OR SYSTEM ARM-TO-ARM INTERFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24934404 ↗
• InjuryApr 14, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE DURING A KIDNEY OPERATION, THE CUSTOMER WAS PLACING THE SPECIMEN IN THE SPECIMEN BAG. THEN THE OPERATOR DISCOVERS A SMALL METAL RING/RUBBER RING LOOSE IN THE ABDOMEN AND WONDERS WHAT THIS WAS. THE CUSTOMER CHECKED THE ROBOTIC INSTRUMENTS AND CONCLUDED THAT THE SMALL RING COMES FROM THE SYNCHROSEAL. THE METAL RING WAS TAKEN OUT AND THE SYNCHROSEAL WAS SAVED FOR A COMPLAINT TO INTUITIVE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO ABNORMALITIES WERE NOTED. AFTER APPROXIMATELY TWO HOURS OF USE DURING A NEPHRECTOMY INVOLVING A LARGE KIDNEY AND SUBSTANTIAL SURROUNDING TISSUE, THE SURGEON REPORTED THE BREAKAGE ISSUE, BELIEVING IT STEMMED FROM AN INTERNAL PROBLEM WITH THE INSTRUMENT ITSELF. ALTHOUGH THE INSTRUMENT COLLIDED WITH OTHER INSTRUMENTS DURING THE PROCEDURE, NO ISSUES WITH ITS FUNCTIONALITY WERE OBSERVED, AND NO FRAGMENTS FELL INSIDE THE PATIENT. THE INSTRUMENT WAS NOT REMOVED BEFORE THE BREAKAGE AS ONLY THE SPECIMEN PLACEMENT REMAINED. NO POST-OPERATIVE IMAGING WAS PERFORMED TO CHECK FOR F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879429 ↗
• InjuryApr 14, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARAESOPHAGIAL HIATAL HERNIA PROCEDURE, THE SYNCHROSEAL INSTRUMENT EXHIBITED A METAL SHAVING FROM ITS JAW. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. AT THE SURGEON¿S REQUEST, THE INSTRUMENT WAS REPLACED WITH A NEW SYNCHROSEAL. THE SHAVING FRAGMENT WAS IMMEDIATELY RETRIEVED BY THE SURGEON, AFTER WHICH THE DEVICE WAS REMOVED AND REPLACED WITH A NEW ONE. NO ADDITIONAL PROCEDURES WERE REQUIRED, AND THERE WERE NO FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872341 ↗
• MalfunctionApr 11, 2026Material Frayed

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM SYNCHROSEAL HAD A FRAYED CABLE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24848728 ↗
• MalfunctionApr 11, 2026No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM, SYNCHROSEAL INSTRUMENT WAS NOT RECOGNIZED BY THE NEW DV5 SYSTEM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE FOLLOWED UP AND OBTAINED ADDITIONAL INFORMATION. THE CUSTOMER WAS NOT AWARE OF ANY MISSING MATERIAL ON THE COMPLAINED PRODUCT. NO FOREIGN BODY ENTERED THE PATIENT. SINCE THE SYNCHROSEAL WAS NOT RECOGNIZED BY THE DV5, IT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24848101 ↗
• MalfunctionApr 10, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE JAWS OF THE SYNCHROSEAL INSTRUMENT WOULD NOT OPEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24841288 ↗