EndoWrist SP 430060Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00886874114384), received between May 12, 2020 and Mar 31, 2023 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 19, 2019Open, Classified

   Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical modality. If residual soil makes contact with the patient, exposure could result in sensitization making future component blood therapy or tissue typing more challenging; additionally if a small piece of inert epoxy were to be retained, scar tissue could form.

   Z-2131-2020 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2023Unintended System Motion; Material Separation; Unintended System Motion; Material Separation

  IT WAS REPORTED THAT PRIOR TO STARTING, PRE-ANESTHESIA, A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE THE SP CAMERA INSTRUMENT HAD THE WIRE BROKEN AT THE DISTAL TIP. THE CUSTOMER ALSO REPORTED THAT THE CAMERA TWISTED OVER TO THE RIGHT DURING ONE OF THE CASES THAT DAY. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER ADVISED RESEATING THE CAMERA AND STERILE ADAPTER ON THE CAMERA ARM, BUT THE ISSUE PERSISTED. THEN, THE ISI TSE SUGGESTED THE ISSUE COULD BE RELATED TO THE ENDOSCOPE. THE SURGEON CONTINUED THE PROCEDURES. THE CUSTOMER WAS PLANNING TO USE ANOTHER ENDOSCOPE FOR THE FOLLOWING CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE NURSE EXPLAINED THE CAMERA WAS MOVING ON ITS OWN WITHOUT THE SURGEON CONTROLLING IT. IT MAY HAVE BEEN AN CAMERA ISSUE ONCE THE CAMERA SHIELD WAS PLACED ON IT. THE SURGERY WAS COMPLETED WITH THE SAME CAMERA WITH NO HARM OR INJURY TO THE PATIENT. THE SURGEON USED THE SAME CAMERA FROM START TO FINISH AND THERE WAS NO NEED TO CHANGE IT. THE CAMERA WAS IN A STERILE AREA/FIELD THUS IT WAS HARD FOR THE NURSE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16659909 ↗
• InjuryOct 21, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, THE SYSTEM DISPLAYED ¿ERROR 430060.¿ THE ERROR DISPLAYED PRIOR TO THE INSERTION OF THE ENDOSCOPE AND THROUGHOUT THE PROCEDURE. THE ENDOSCOPE WAS INSPECTED PRIOR TO USE AND ¿LOOKED NORMAL.¿ THE DISPLAYED SCREEN FLIPPED UP AND DOWN RANDOMLY ALTHOUGH THE SURGEON HAD NOT PUSHED THE ¿CAMERA ABOVE/BELOW¿ BUTTON TO CAUSE THIS. THE ISSUE INITIALLY OCCURRED WHEN THE SURGEON WAS HOLDING THE CAMERA BY HAND PRIOR TO DOCKING. THE ENDOSCOPE VIEW WAS 30 DEGREES DOWN AND IT STARTED TO CHANGE FROM DOWN TO UP BY ITSELF WITHOUT PUSHING THE BUTTON ON THE HOUSING OF THE ENDOSCOPE. THE ISSUE OCCURRED AGAIN WHEN THE ENDOSCOPE WAS INSTALLED ON THE SYSTEM AFTER DOCKING WHILE THE SURGEON WAS DISSECTING VESSELS AROUND THE UTERUS; THE SURGICAL FIELD WAS SUDDENLY OUT OF VIEW. THIS HAPPENED THREE TO FOUR TIMES DURING THE PROCEDURE. THE ENDOSCOPE STAYED IN THE SAME POSITION WHILE INSTALLED ON THE USM (UNIVERSAL SURGICAL MANIPULATOR), BUT THE VIEW WOULD CHANGE UPSIDE DOWN ON ITS OWN. TROUBLESHOOTING WAS PERFORMED BY UNINSTALLING THE ENDOSCOPE AND REINSTALLING QUICKLY. IT WOULD THEN WORK CORRECTLY FOR A WHILE BEFORE THE LOSS OF VISIO

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15655223 ↗
• InjuryJun 18, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON WAS USING A NEW SINGLE PORT (SP) ACCESS PORT AND EXPERIENCED RUBBING OF THE INSTRUMENTS. THE SURGEON NOTICED IT SPECIFICALLY WITH THE CAMERA AND THE SHEATH. THE SHEATH WAS RUBBED RAW TO WHERE A HOLE APPEARED AND PIECES FELL INTO PATIENT. THE PIECES FELL INTO ABDOMEN AND MOST OF THE PIECES WERE RETRIEVED, BUT A FEW SMALL PIECES COULD NOT BE PICKED OUT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THIS OCCURRED DURING A PYELOPLASTY PROCEDURE ON (B)(6) 2022. THE SURGEON CONFIRMED THAT THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NOTHING ABNORMAL ABOUT THE INSTRUMENT. HE WAS UNABLE TO RETRIEVE THE FRAGMENTS AS THEY WERE TINY LITTLE SPECKS OF THE SHEATH THAT FLAKED OFF AS THE RUBBING OCCURRED DURING MOVEMENT OF ENDOSCOPE. NO X-RAY OR ULTRASOUND WAS PERFORMED. THERE WAS NO CONVERSION TO LAPAROSCOPY OR OPEN PROCEDURE DUE TO THE ISSUE. THERE WAS NO ISSUE WITH THE USE OF THE INSTRUMENT OR ANY INSTRUMENT COLLISIONS DURING PROCEDURE. THERE WAS NO ISSUE REM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14740055 ↗
• MalfunctionMay 25, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED LARYNGECTOMY (TRACHEO-ESOPHAGEAL PUNCTURE) SURGICAL PROCEDURE, THE SP CAMERA HAD A CHIP AT THE TIP. A SIMILAR BACKUP ENDOSCOPE WAS USED TO CONTINUE WITH THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION FROM THE CUSTOMER ABOUT THE COMPLAINT: THE TYPE OF DA VINCI-ASSISTED SURGICAL PROCEDURE PERFORMED WAS A LARYNGECTOMY (TRACHEO-ESOPHAGEAL PUNCTURE). THE EVENT DATE OF THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS (B)(6) 2022. THE CAMERA WAS INSPECTED PRIOR TO USE AND THEN HANDED OFF FIELD. THE STAFF STATED THE CAMERA WAS CHIPPED. NO PHOTOGRAPHIC IMAGES OF THE DEVICE OR A VIDEO RECORDING OF THE PROCEDURE IS AVAILABLE FOR ISI REVIEW. NO FRAGMENTS FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACK UP ENDOSCOPE. THERE WAS NO REPORT OF PATIENT INJURY. THE SCOPE NEVER REACHED THE PATIENT. WITH REGARDS TO THE QUESTIONS ABOUT THE PATIENT DEMOGRAPHICS, THE CUSTOMER NOTED THAT THE CAMERA INSTRUMENT DID NOT REACH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14497389 ↗
• MalfunctionApr 8, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CAMERA INSTRUMENT WAS OBSERVED TO HAVE HAD AN ERROR CODE WHEN PLUGGED IN. A BACKUP CAMERA OF THE SAME KIND WAS USED, AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14053702 ↗
• MalfunctionJan 18, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A SINGLE PORT (SP) CAMERA EXHIBITED AN OVERHEATING ERROR MESSAGE. THE CUSTOMER USED A BACKUP SP CAMERA INSTRUMENT TO COMPLETE THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ON 30-DEC-2021, INTUITIVE SURGICAL, INC. (ISI) HAS PERFORMED FOLLOW-UP TO REQUEST ADDITIONAL INFORMATION, BUT NO FURTHER DETAILS WERE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13285764 ↗
• MalfunctionJan 13, 2021Degraded; Material Fragmentation; Degraded; Material Fragmentation

  IT WAS REPORTED THAT, DURING CENTRAL PROCESSING, THE CUSTOMER NOTED ¿BIOBURDEN BAKED ONTO SCOPE.¿ THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED TO FOLLOW UP WITH THE REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER NO LONGER WORKS FOR THE HOSPITAL. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11160518 ↗
• MalfunctionDec 11, 2020Degraded; Material Fragmentation; Degraded; Material Fragmentation

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SINGLE PORT (SP) CAMERA HAD A DARK IMAGE ISSUE WITH ERROR CODE 48406. THE CUSTOMER USED A BACKUP ENDOSCOPE OF THE SAME KIND TO CONTINUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10990188 ↗
• MalfunctionDec 1, 2020Degraded; Material Fragmentation; Degraded; Material Fragmentation

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOWRIST SINGLE PORT (SP) CAMERA FAILED DISTAL TIP INSPECTION. THE ENDOSCOPE WAS REPLACED, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS BEING COMPLETED AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10926282 ↗
• MalfunctionMay 12, 2020Degraded; Material Fragmentation; Degraded; Material Fragmentation

  IT WAS REPORTED THAT THE SINGLE PORT CAMERA HAD NO PICTURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WAS NO REPORTS OF FRAGMENT(S) FALLING INSIDE THE PATIENT, PATIENT HARM, ADVERSE OUTCOME OR INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: THE ISSUE WAS DISCOVERED PRIOR TO STARTING AND THE PROCEDURE WAS COMPLETED. THE CUSTOMER WAS NOT ABLE TO PROVIDE ANY PATIENT INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10047800 ↗