Endowrist SP 430077Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00886874122228), received between Sep 7, 2023 and Apr 16, 2026 — classified as 13 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Image Orientation Incorrect” (8 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Image Orientation Incorrect; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TONGUE BASE RESECTION MALIGNANT SURGICAL PROCEDURE, THAT THE CUSTOMER CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) STATING THAT THE UNIVERSAL SURGICAL MANIPULATOR (USM) ARMS WERE MOVING IN THE OPPOSITE DIRECTION. TSE REVIEWED THE SYSTEM LOGS AND FOUND THEM TO BE CLEAN, THEN INSTRUCTED THE CUSTOMER TO UNINSTALL AND RESEAT THE ENDOSCOPE, WHICH RESOLVED THE ISSUE AND ALLOWED THE CUSTOMER TO CONTINUE WITH THE SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899804 ↗
• MalfunctionApr 6, 2026Image Orientation Incorrect

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) INFORMED TECHNICAL SUPPORT ENGINEER (TSE) THAT THE SYSTEM WAS NOT READING THE ENDOSCOPE POSITION CORRECTLY AFTER SWAPPING THE ENDOSCOPE FROM BELOW TO ABOVE POSITION. THE TSE REVIEWED THE LOGS AND FOUND RECOGNITION ERROR ON THE CAMERA ARM. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793118 ↗
• MalfunctionMar 23, 2026Image Orientation Incorrect

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE CUSTOMER WAS HAVING A CAMERA OPERATION ISSUE. THE SINGLE PORT FIREFLY ENDOSCOPE AUTOMATICALLY SWITCHED TO COBRA POSE AFTER INSTALLING THE ENDOSCOPE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670097 ↗
• InjuryMar 11, 2026No Display/Image

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24566255 ↗
• MalfunctionFeb 27, 2026Image Orientation Incorrect

  IT WAS REPORTED THAT THE ENDOSCOPE METAL END WAS JAMMED AND WAS NOT MOVING CORRECTLY. THERE WAS NO REPORT OF PATIENT INJURY OR HARM. INTUITIVE FOLLOWED UP BUT CUSTOMER DID NOT HAVE ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24470594 ↗
• InjuryFeb 26, 2026Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A CAMERA SELF-TEST FAILED, AND IT COULD NOT BE RESOLVED BY RECONNECTING THE CONNECTOR OR PERFORMING A POWER CYCLE ON THE SYSTEM. THE TECHNICAL SERVICE ENGINEER (TSE) CONFIRMED ERROR 48221 AND ADVISED THE CUSTOMER TO CLEAN THE CONNECTOR AND RECONNECT IT AGAIN, BUT THE ISSUE PERSISTED. THE TSE ADVISED THE CUSTOMER TO CHANGE TO ANOTHER CAMERA; HOWEVER, HE DID NOT HAVE A BACKUP CAMERA, SO HE DECIDED TO CONVERT THE SURGERY TO LAPAROSCOPIC. 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 DAMAGE OR ABNORMALITIES WERE FOUND. DURING THE PROCEDURE, A CAMERA MALFUNCTION OCCURRED BEFORE THE TIMEOUT, AND SINCE THERE WAS NO STERILE SPARE CAMERA AVAILABLE, IT WAS NECESSARY TO CONVERT TO A TRADITIONAL LAPAROSCOPIC APPROACH. THE PATIENT TOLERATED THE CHANGE WELL, AND THERE WAS NO INJURY OR HEALTH DAMAGE REPORTED AS A RESULT OF THE CONVERSION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24465247 ↗
• MalfunctionFeb 7, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE ENDOSCOPE WAS BROKEN AT THE ARTICULATING JOINT. INTUITIVE FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER HAS NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24285482 ↗
• MalfunctionFeb 3, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, SINGLE PORT (SP) FIREFLY ENDOSCOPE HAD A BROKEN SEAL. THE PROCEDURE WAS COMPLETED USING A BACKUP ENDOSCOPE AND IT IS UNKNOWN IF ANY FRAGMENTS FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE FOLLOWED UP BUT NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24243366 ↗
• MalfunctionJan 20, 2026Image Orientation Incorrect

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER INFORMED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT THE IMAGE OF A SINGLE PORT 0-DEGREE FIREFLY CAMERA WAS UPSIDE DOWN, AND IT WAS ALWAYS MISALIGNED. THE CUSTOMER SELECTED UP/DOWN BUTTONS ON THE SURGEON SIDE CONSOLE (SSC) TOUCHPAD, WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24123216 ↗
• MalfunctionJan 16, 2026Image Orientation Incorrect

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT THE CAMERA IMAGE WAS UPSIDE DOWN, AND IT WAS ALWAYS MISALIGNED. THE CUSTOMER SELECTED UP/DOWN BUTTONS ON THE SURGEON SIDE CONSOLE (SSC) TOUCHPAD, WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24101239 ↗
• MalfunctionJan 8, 2026Image Orientation Incorrect

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TRANSANAL LOCAL EXCISION SURGICAL PROCEDURE, THE CUSTOMER FOUND THAT THE IMAGE ORIENTATION WAS FLIPPED ON THE SINGLE PORT FIREFLY ENDOSCOPE. THE SURGEON CONFIRMED THAT THE CONTROLS WERE INVERTED AND TRIED REBOOTING THE SYSTEM AND RESEATING THE INSTRUMENT ARM DRAPES, BUT THE ISSUE REMAINED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER ADVISED THE CUSTOMER TO EXCHANGE THE ENDOSCOPE, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24000573 ↗
• InjuryDec 16, 2025Device Reprocessing Problem; Device Reprocessing Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23817711 ↗
• InjuryDec 16, 2025Device Reprocessing Problem; Device Reprocessing Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23817681 ↗
• InjuryDec 16, 2025Output Problem; Output Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23816308 ↗
• InjuryDec 15, 2025No Device Output; No Device Output

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23802846 ↗
• MalfunctionDec 3, 2025Material Integrity Problem; Material Integrity Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23709913 ↗
• MalfunctionDec 2, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED OVARIAN CYSTECTOMY SURGICAL PROCEDURE, THERE WAS AN ISSUE WITH THE SINGLE PORT (SP) CAMERA INSTRUMENT'S FOCUSING NOT BEING CORRECT. AFTER THE SURGERY, AND AFTER CLEANING WAS COMPLETED, A CAMERA WAS CONNECTED FOR DA VINCI SP PRACTICE, BUT THE ENDOSCOPE SELF-TEST FAILED. A MESSAGE SAYING "CLEAN CONNECTOR OR REPLACE ENDOSCOPE" APPEARED, MAKING IT UNUSABLE. NO FRAGMENT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23690517 ↗
• InjuryDec 1, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED A SELF-TEST FAILURE ON TWO ENDOSCOPES WHEN THEY WERE CONNECTED TO THE ENDOSCOPE CONTROLLER (EC). THE TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND FOUND ERRORS ON THE EC AND ENDOSCOPES (B)(6). THE TSE HAD THE CUSTOMER CLEAN THE ENDOSCOPE CONNECTORS, HARD POWER CYCLE, AND RESEAT THE CABLES, BUT THE ISSUE PERSISTED. THE CUSTOMER CONVERTED THE CASE FROM SINGLE PORT TO LAPAROSCOPY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT THE PORTS WERE PLACED WHEN THE ISSUE OCCURRED. IT WAS CONFIRMED THAT THE PORTS WERE NOT INCREASED AND THE PATIENT TOLERATED THE CONVERSION FROM SINGLE PORT TO TRADITIONAL LAPAROSCOPY WITHOUT ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23688346 ↗
• InjuryDec 1, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED A SELF-TEST FAILURE ON TWO ENDOSCOPES WHEN THEY WERE CONNECTED TO THE ENDOSCOPE CONTROLLER (EC). THE TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND FOUND ERRORS ON THE ENDOSCOPE CONTROLLER (EC) AND ENDOSCOPES (B)(6) AND (B)(6). THE TSE HAD THE CUSTOMER CLEAN THE ENDOSCOPE CONNECTORS, HARD POWER CYCLE, AND RESEAT THE CABLES, BUT THE ISSUE PERSISTED. THE CUSTOMER CONVERTED THE CASE FROM SINGLE PORT TO LAPAROSCOPY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT THE PORTS WERE PLACED WHEN THE ISSUE OCCURRED. IT WAS CONFIRMED THAT THE PORTS WERE NOT INCREASED AND THE PATIENT TOLERATED THE CONVERSION FROM SINGLE PORT TO TRADITIONAL LAPAROSCOPY WITHOUT ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23687710 ↗
• MalfunctionSep 15, 2025Material Integrity Problem; Material Integrity Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058656 ↗
• MalfunctionMay 9, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE SP ENDOSCOPE FIREFLY HAD DISTAL JOINT CRUSHED INWARD. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: PATIENT WAS NOT HARMED. THERE WAS NO DELAY IN CASE AND BACKUP WAS AVAILABLE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21991295 ↗
• MalfunctionMar 21, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY - RADICAL EXTRAPERITONEAL W/O LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT THEY EXPERIENCED INSTRUMENTS BECOMING INVERTED. CUSTOMER STATED THAT ISSUE OCCURS WITH MULTIPLE INSTRUMENTS AND HAS OCCURRED IN THE PAST. CUSTOMER WAS INQUIRING AS TO POTENTIAL CAUSES. CUSTOMER HAD RESOLVED THE ISSUE PRIOR TO CALLING IN WITH A NEW INSTRUMENT. THE TSE INFORMED CUSTOMER THAT THE ALIGNMENT OF THE ENTRY GUIDE IN RELATION TO CAMERA UP/DOWN COULD CAUSE AN ALIGNMENT ISSUE WHERE THE INSTRUMENTS WILL NOT MOVE AS EXPECTED. THE PROCEDURE WAS COMPLETED AS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21668698 ↗
• InjuryDec 4, 2024Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RECONSTRUCTIVE UROLOGY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT TO REPORT THAT THEY WERE PRESENTED A MESSAGE STATING THE SINGLE PORT (SP) CAMERA INSTRUMENT WAS EXPIRED. THE CUSTOMER INQUIRED IF IT WAS POSSIBLE TO OVERRIDE THE FEATURE AND THE TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THERE WAS NO ABILITY TO OVERRIDE. THE TSE CONFIRMED THE ERROR IN THE LOGS AND WALKED THE CUSTOMER THROUGH A HARD POWER CYCLE OF THE SYSTEM WITH NO CHANGE. THE CUSTOMER INFORMED THE TSE THEY WERE WAITING FOR ANOTHER ENDOSCOPE TO BE REPROCESSED OR DELIVERED FROM ANOTHER FACILITY. THE CUSTOMER ESTIMATED A 2 HOUR DELAY POST ANESTHESIA AND INTENDED TO PROCEED ROBOTICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20839839 ↗
• MalfunctionDec 3, 2024Material Integrity Problem; Material Integrity Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 20829031 ↗
• MalfunctionNov 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 20607201 ↗