da Vinci SP 380941Recalls & reported problems

Summary

The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 00886874114742), received between Mar 20, 2022 and Sep 30, 2026 — classified as 38 injuries, 95 malfunctions.

The most frequently reported specific device problem is “Output Problem” (44 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 133 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Power Up; Material Split, Cut or Torn

  Patient problems: Insufficient Information

  MAUDE report 50953697 ↗
• MalfunctionSep 29, 2026Energy Output Problem

  It was reported that during a da Vinci-assisted surgical procedure, a remote site representative had contacted the Intuitive Surgical, Inc. (ISI) Technical Support Engineer (TSE) on behalf of the user site to report that monopolar energy could not be activated and that the cord indicator on the energy switch module had been amber while the other indicators had been blue. Prior to the call, users had verified that all cords had been connected correctly and had replaced the energy cord and the instrument, but the issue had persisted. The TSE had asked the caller to verify that the instrument cord had been connected to the energy switch module rather than the generator, and the caller had confirmed this had already been verified based on a photo of the setup. The TSE had then advised restarting the system, and the caller had planned to relay that instruction to the user site and call back; the call had ended before additional troubleshooting details had been obtained. The procedure outcome is unknown with no reported injury.ISI followed up with the initial reporter and obtained the following additional information: The case was completed robotically but the monopolar energy wasn't wor

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928033 ↗
• MalfunctionSep 24, 2026Output Problem

  It was reported that during a da Vinci assisted ureteroplasty surgical procedure, the sheath indicator on the Energy Shield Monitor (ESM) displayed yellow with a warning related to the instrument sheath/cord. The procedure was completed as planned with no patient injury.Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained the following additional information: The customer noted the procedure was continued and completed despite the yellow cord/sheath indicator without using monopolar, with bipolar and scissors. The monopolar device kept breaking down, so it was not available throughout the procedure. Colleagues had contacted phone support and tried everything they could think of; three cables were replaced, a new device was installed, and the system was completely shut down, etc. No alternative energy source, different instrument, or different system configuration of the sort was used to complete the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877582 ↗
• MalfunctionSep 22, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861241 ↗
• InjurySep 10, 2026Output Problem

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50724639 ↗
• MalfunctionAug 21, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50382123 ↗
• InjuryAug 7, 2026Output Problem

  It was reported that during a da Vinci-assisted procedure, after port placement, the system generated multiple 48406 faults across multiple scopes. The surgeon elected to convert the procedure to another da Vinci system.Intuitive Surgical, Inc. (ISI) made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 50178187 ↗
• InjuryApr 16, 2026Grounding Malfunction

  IT WAS REPORTED THAT PRIOR TO A SINGLE PORT (SP) DA VINCI-ASSISTED SIMPLE EXTRAPERITONEAL PROSTATECTOMY PROCEDURE, THE GREY NEUTRAL WIRE WHERE IT CONNECTS TO THE SINGLE PORT (SP) ENERGY SHIELD MONITOR (ESM) WAS STRIPPED AND HAD BEEN PULLED OUT. THE ISSUE WAS IDENTIFIED AFTER ANESTHESIA INDUCTION BUT PRIOR TO PORT PLACEMENT. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CUSTOMER THAT NO MONOPOLAR ENERGY WOULD BE AVAILABLE WITHOUT THAT CONNECTION AND THE SYSTEM COULD NOT BE USED WITH A THIRD PARTY GENERATOR. THE CALLER INDICATED THAT THE CUSTOMER WAS PLANNING ON GETTING AN ESM FROM ANOTHER SYSTEM THAT WAS NOT IN USE AT ANOTHER SITE. HOWEVER, THE TSE ADVISED THE CALLER USING A DIFFERENT ESM WAS NOT RECOMMENDED AND SHOULD NOT BE PERFORMED. THE TSE INFORMED THE CALLER THAT AN FSE WOULD BE REQUIRED TO REPLACE THE ESM. DUE TO THE ISSUE, THE CUSTOMER ELECTED TO CONVERT THE CASE TO A DA VINCI MULTI-PORT SYSTEM WHICH REQUIRED MORE INCISIONS THAT ORIGINALLY PLANNED. IT WAS REPORTED THE PATIENT TOLERATED THE CONVERSION WITH NO POST-OPERATIVE COMPLICATIONS REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24899420 ↗
• InjuryApr 16, 2026Visual Prompts will not Clear

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24899158 ↗
• MalfunctionApr 7, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED TECH SUPPORT ENGINEER (TSE) TO REPORT THAT THE SYSTEM HAD AN ERROR 323 INDICATING A PROBLEM WITH THE ENERGY SHIELD MONITOR (ESM). TSE WALKED THE CUSTOMER THROUGH A HARD POWER CYCLE ON THE ESM AND THE TOWER AND CHECKED ALL POWER AND COMMUNICATION CABLES WITH NO CHANGE. THE PROCEDURE WAS ABORTED TO ANOTHER DV SYSTEM/NO PATIENT INVOLVEMENT WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24809788 ↗
• MalfunctionMar 30, 2026Energy Output Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24724049 ↗
• InjuryMar 30, 2026Power Problem

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED LEFT NEPHROURETERECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED A INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE ENERGY SHIELD MONITOR (ESM) WOULD NOT LIGHT UP AND A MESSAGE ON THE MONITOR INDICATED THAT THE ENERGY SHIELD COULD NOT BE DETECTED. THE TSE INSTRUCTED THE CUSTOMER TO CHECK ALL THE CABLES ON THE BACK OF THE ESM TO ENSURE THEY WERE FULLY SEATED, WHICH THEY WERE. THE CUSTOMER ALSO CHECKED THE CABLES ON THE OTHER END, WHICH WERE ALSO FULLY SEATED. THE CUSTOMER MENTIONED A SCREEN MESSAGE INDICATING THAT THE VIDEO PROCESSOR (VP) WAS NOT DETECTED. UPON CHECKING, THE GRAY FIBER WAS FOUND TO BE MISSING, SO THE CUSTOMER USED A FIBER FROM ANOTHER SYSTEM TO CONNECT THE VP TO THE CORE. THE TSE ALSO HAD THE CUSTOMER CHECK THE ROCKER SWITCH TO ENSURE IT WAS IN THE ON POSITION. A HARD POWER CYCLE OF THE SYSTEM WAS PERFORMED, BUT THE ESM STILL DID NOT LIGHT UP. THE ERBE WAS ON, WITH MONOPOLAR AND NEUTRAL PAD CONNECTIONS PLUGGED IN. THE CUSTOMER NOTED THAT ANOTHER SYSTEM HAD ISSUES WITH ARM 1 AND THAT TWO CASES WERE SCHEDULED FOR NEXT WEEK. THE CUSTOMER REQUESTED THAT THE FIELD SERVICE

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24716660 ↗
• MalfunctionMar 30, 2026Output Problem

  IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM, ERROR 317 WAS OBSERVED DURING THE POWER-ON SELF TEST. THE ERROR COULD BE OVERRIDDEN; HOWEVER, AFTER POWERING DOWN THE SYSTEM, ERROR 40068 OCCURRED. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE ERROR LOG AND IDENTIFIED THAT THE ISSUE POINTED TO THE AUXILIARY VIDEO PROCESSOR (AVP) NODE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24710123 ↗
• MalfunctionMar 30, 2026Output Problem

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED RADICAL TONSILLECTOMY SURGICAL PROCEDURE, ERROR 32209 OCCURRED. PRIOR TO CALLING TECHNICAL SUPPORT, CLINICAL SALES REPRESENTATIVE (CSR) POWER CYCLED SYSTEM BUT ERROR PERSISTED. ALL LEDS ON THE ENERGY SHIELD MONITOR (ESM) WERE FLASHING YELLOW. INTUITIVE SURGICAL (IS) TECHNICAL SUPPORT ENGINEER (TSE) ASKED CSR TO POWER OFF THE SYSTEM AND GUIDED CSR THROUGH TO VERIFY THE INTEGRITY OF ALL CONNECTIONS ON ESM AND RELATED CONNECTIONS ON CORE AND VIDEO PROCESSOR (VP). CSR VERIFIED ALL CONNECTIONS WERE SEATED PROPERLY. TSE ALSO GUIDED CSR TO VERIFY CONNECTIONS BETWEEN ERBE AND ESM, ALL VERIFIED. TSE HAD THE CSR TOGGLE CIRCUIT BREAKER ON ESM. AFTER RESTART SYSTEM STARTED UP WITH SAME ERROR 32209 AND ALL LEDS ON ESM WERE STILL FLASHING YELLOW. SYSTEM WAS NOT CONNECTED TO ONSITE DURING CALL, SO NO RELEVANT LOGS COULD BE OBTAINED. CSR INFORMED TSE THAT THE PROCEDURE WILL BE PERFORMED AS AN OPEN SURGERY DUE TO THE ISSUE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24710031 ↗
• MalfunctionMar 30, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED LEFT HEMICOLECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT A NON-RECOVERABLE FAULT CODE INDICATING MONOPOLAR ENERGY WAS NOT AVAILABLE DURING SYSTEM SETUP, WITH NO PATIENT INVOLVED. TECHNICAL SUPPORT FIRST INSTRUCTED THE CUSTOMER TO POWER CYCLE THE SYSTEM USING EMERGENCY POWER OFF (EPO) AND TO RESEAT THE FIBER CABLES AS WELL AS THE ENERGY SHIELD MONITOR (ESM), BUT THE ERROR PERSISTED AFTER EACH ATTEMPT. TECHNICAL SUPPORT VERIFIED THAT CABLES WERE PROPERLY CONNECTED. SYSTEM LOGS WERE NOT ACCESSIBLE, SO FURTHER TROUBLESHOOTING WAS LIMITED. ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO SITE TO FURTHER TROUBLESHOOT. THE PROCEDURE WAS ABORTED WITH NO PATIENT INVOLVEMENT WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709994 ↗
• MalfunctionMar 30, 2026Output Problem

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, C-00 AND C-33 ERRORS APPEARED ON INTEGRATED ELECTROSURGICAL UNIT (IESU) AFTER STARTUP OF THE SYSTEM. CUSTOMER PERFORMED POWER CYCLE OF IESU; HOWEVER, THE SAME ISSUE PERSISTED. THE PROCEDURE WAS ABORTED WITH NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709984 ↗
• MalfunctionMar 30, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED TECHNICAL SUPPORT ENGINEER (TSE) REGARDING A REPEATED ERROR 32209 THAT OCCURRED AT START-UP. THE CUSTOMER HARD POWER-CYCLED THE SYSTEM; HOWEVER, THE ISSUE PERSISTED. ONSITE WAS NOT CONNECTED AT THE TIME OF THE CALL. THE CUSTOMER SENT EVENT LOGS AND TSE FOUND ERROR 317 AND 40068 POINTING TO AUXILIARY VIDEO BOARD- PRINTED CIRCUIT ASSEMBLY (AVP). THE PROCEDURE WAS ABORTED WITH NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709953 ↗
• MalfunctionMar 30, 2026Output Problem

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED PYELOPLASTY SURGICAL PROCEDURE, THE CUSTOMER WAS HAVING AN ERROR 319 AT START UP. PRIOR TO CONTACTING TECHNICAL SUPPORT, CUSTOMER TRIED HARD POWER CYCLING THE SYSTEM WITH NO IMPROVEMENT. TECHNICAL SUPPORT ENGINEER (TSE) TRIED CHECKING ERROR LOGS BUT SYSTEM WAS NOT CONNECTED TO ONSITE. TSE REVIEWED THE ERROR LOGS AND CONFIRMED THAT THE ERROR WAS POINTING TO THE ENDOSCOPE CONTROLLER (EC). TSE GUIDED CUSTOMER TO CHECK ALL POWER CABLES IN THE POWER STRIP AND PUSH THEM IN. TSE GUIDED CUSTOMER TO HARD POWER CYCLE THE SYSTEM AND CHECK ALL BLUE FIBER CABLES (BFC) AS THE PATIENT SIDE CART (PSC) DID NOT POWER ON WITH THE REST OF THE SYSTEM, BUT THERE WAS NO IMPROVEMENT. TSE GUIDED CUSTOMER TO PUSH THE POWER CABLE IN THE EC AND TRY A DIFFERENT ONE, AS WELL AS RECONNECT THE ORANGE FIBER ABLE IN BOTH THE EC AND THE VIDEO PROCESSOR (VP), WITH NO IMPROVEMENT. CUSTOMER CONFIRMED THAT THE ERROR WAS STILL POINTING TO THE SAME NODE AND TSE EXPLAINED THAT THE EC WOULD NEED TO BE SERVICE AS IT SEEMED TO BE DEAD. CUSTOMER EXPLAINED THEY WOULD HAVE TO CANCEL THE SURGERY. THE PROCEDURE WAS ABORTED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709880 ↗
• MalfunctionMar 30, 2026Failure to Power Up

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE VISION SIDE CART (VSC) POWER BUTTON WAS DIM AND THERE WAS NO RESPONSE WHEN PRESSING IT. THE CUSTOMER STATED THAT THEY COULD HEAR THE FAN RUNNING INSIDE THE CORE. TECHNICAL SUPPORT ENGINEER (TSE) GUIDED THE CUSTOMER TO CHECK THE POWER CORD AND POWER SWITCH ON THE CORE, AND CONFIRMED THE CONNECTION IS OKAY AND THE SWITCH WAS AT "ON". CUSTOMER CYCLED POWER SWITCH AND BREAKER, BUT THE ISSUE PERSISTED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709872 ↗
• MalfunctionMar 30, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, A NON-RECOVERABLE FAULT 32209 APPEARED. CUSTOMER PERFORMED A POWER CYCLE OF THE SYSTEM, HOWEVER THE ISSUE PERSISTED. ONSITE WAS DISCONNECTED. TECHNICAL SUPPORT ENGINEER (TSE) ADVISED CUSTOMER TO SEE POP-UP EVENT LOGS. CUSTOMER CONFIRMED THAT THERE RECOVERABLE FAULT 317 WAS RECORDED. THE PROCEDURE WAS ABORTED WITH NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709856 ↗
• MalfunctionMar 25, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, NON-RECOVERABLE ERROR 319 OCCURRED DURING SYSTEM POWER ON. THE CUSTOMER ATTEMPTED TO RESOLVE THE ISSUE BY REBOOTING AND PERFORMING A HARD POWER CYCLE, BUT THE PROBLEM PERSISTED. ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO SITE TO FURTHER TROUBLESHOOT. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24694839 ↗
• MalfunctionMar 25, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM, BROKEN GUIDE PINS WERE FOUND ON THE HALO OF THE ENTRY GUIDE MANIPULATOR. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24694579 ↗
• MalfunctionMar 25, 2026Output Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24684338 ↗
• MalfunctionMar 24, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, ERROR 32209 OCCURRED REPEATEDLY WHEN THE SYSTEM WAS POWERED ON. THE USER REBOOTED THE SYSTEM BUT THE ISSUE PERSISTED. TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CUSTOMER PERFORM A HARD POWER CYCLE OF THE SYSTEM, BUT THE ISSUE PERSISTED. ONSITE WAS NOT AVAILABLE AT THE MOMENT. TSE CHECKED THE EVENT LOGS AND FOUND ERROR 32209 WITH ERRORS 317 AND 40068. THE PROCEDURE WAS ABORTED WITH NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24682857 ↗
• MalfunctionMar 24, 2026Energy Output Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24678754 ↗