EndoWrist 470430Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00886874112700), received between May 6, 2020 and Feb 27, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Positioning Problem

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24477193 ↗
• MalfunctionJun 3, 2025Break; Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE ENDOWRIST 30 STAPLER HAD A SCREW MISSING FROM THE TIP. THE USER COMPLETED THE PROCEDURE 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: THERE WAS NO INSTRUMENT COLLISION AND NO FRAGMENT FALL INTO THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22129524 ↗
• MalfunctionMar 18, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE TIP OF THE STAPLER 30 INSTRUMENT WOULD NOT CLAMP DOWN. NO FRAGMENT FELL INTO THE PATIENT. IT WAS NOTED THAT THE DEVICE WAS NOT USED ON THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21636262 ↗
• MalfunctionDec 12, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL COLECTOMY SURGICAL PROCEDURE, THE STAPLER 30 INSTRUMENT BLADE DID NOT CLOSE AND THE TISSUE COULD NOT BE CUT OFF BECAUSE IT DID NOT MOVE DURING USE. THOUGH IT WAS USABLE IN THE FIRST AND SECOND TIME, THE BLADE OF THE THIRD WINDING DID NOT CLOSE, AND EVEN IF THE TIP WAS CHECKED, IT WAS NOT DAMAGED, AND THE REPLACEMENT BLADE WAS REMOVED WITHOUT RESISTANCE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FIRST FIRE WORKED. THE TARGET TISSUE AT THE TIME OF ANASTOMOSIS BETWEEN THE ILEUM AND THE ANUS WHEN ADVANCED 1 CM. WHEN PERFORMING AN ANASTOMOSIS BETWEEN THE ILEUM AND THE ANUS, IT STOPPED HALFWAY WHEN IT HAD ADVANCED 1 CM. IT DISPLAYED A MESSAGE OF "BLADE MAY BE EXPOSED." A NEW STAPLER INSTRUMENT WAS TAKEN OUT AND COMPLETED THE FIRE WITH A GREEN RELOAD. THE EVENT INVOLVED A FAILURE TO FIRE AND PARTIAL FIRE. THE EVENT DID NOT INVOLVE TISSUE BEING PUSHED FORWARD/DRAGGED DURING THE FIRING PROCESS. THERE WERE MALFORMED OR UNFORMED STAPLES. THE RELOAD HAD AN EXPOSED BLADE. THERE WERE NO STAPLES MISSING FROM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20920698 ↗
• MalfunctionJul 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE CUSTOMER NOTICE TORN INSULATION ON THE TIP OF THE STAPLER 30. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19698629 ↗
• MalfunctionMay 27, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE THAT THE CUSTOMER HAD ISSUES WITH THE CABLE POPPING OUT OF THE JAW HINGE OF THE ENDOWRIST STAPLER 30 INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015747 ↗
• MalfunctionDec 15, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE, THE STAPLER 30 INSTRUMENT WAS NOT ARTICULATING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DA VINCI COORDINATOR RESPONDED STAPLERS DID NOT MOVE IN NONINTUITIVE WAY . THE STAPLERS WAS NOT MOVING AT ALL. THE BACKUP INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY OR HARM TO THE PATIENT. PATIENT DETAILS WERE ALREADY PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15988074 ↗
• MalfunctionJun 26, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGECTOMY TRANSTHORACIC CHEST ANASTOMOSIS SURGICAL PROCEDURE, THE STAPLER 30 INSTRUMENT RELOAD WAS FIRED AND THE INSTRUMENT JAWS LOCKED. 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 14825134 ↗
• MalfunctionSep 12, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SPLENECTOMY SURGICAL PROCEDURE, THE STAPLER 30 INSTRUMENT WAS FIRED BUT THEN FROZE. THE CUSTOMER HAD TO USE THE UNLOCK KEY TO REMOVE THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER INDICATED THAT THE STAPLER 30 INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS OBSERVED. IT WAS NOTED THAT THE REPORTED ISSUE OCCURRED DURING THE FIRST USE OF THE STAPLER INSTRUMENT. THE REPORTER INFORMED THAT AT THE TIME, THE SURGEON WAS ATTEMPTING TO STAPLE THE ARTERY OF THE SPLEEN. AT THE TIME THE SURGEON TRIED TO STAPLE ACROSS THE ARTERY, AN ERROR POPPED UP STATING THE STAPLER MALFUNCTIONED AND WAS LOCKED. THE REPORTER INFORMED A STAPLER KEY REQUIRED MESSAGE WAS OBSERVED. A WHITE RELOAD WAS USED AT THE TIME BECAUSE THE TARGET WAS A VESSEL. IT WAS CONFIRMED THAT THE STAPLER 30 INSTRUMENT JAWS WERE STUCK ON TISSUE AND THE STAPLER RELEASE KIT (SRK) WAS USED SUCCESSFULLY TO REMOVE THE INSTRUMENT FROM THE PATIENT. THERE WAS NO OBSERVATION OF TISSUE TENSION NOR TISSUE BUNCHING. NO ADVERSE EFFECT TO TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12458006 ↗
• MalfunctionJan 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS INITIALLY REPORTED THAT AFTER A DA VINCI-ASSISTED APPENDECTOMY ON (B)(6) 2020. THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2020 FOR REMOVAL OF A FOREIGN OBJECT WHICH WAS DISCOVERED TO BE A PORTION OF A ROBOTIC STAPLER SHEATH. ON 29-DEC-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: A DA VINCI-ASSISTED APPENDECTOMY PROCEDURE WAS PERFORMED ON (B)(6) 2020 DUE TO APPENDICITIS. DURING THE INITIAL PROCEDURE, THERE WERE NO SYSTEM ERRORS OR ISSUES, NO INSTRUMENT ISSUES, AND NO ACCESSORY ISSUES. THE SYSTEM AND INSTRUMENTS WORKED AS EXPECTED AND AS INTENDED. EVERYTHING WENT WELL AND AS PLANNED. THE PROCEDURE COMPLETED ROBOTICALLY WITHOUT INCIDENT AND WITHOUT PATIENT HARM OR INJURY. THERE WAS NO KNOWN FRAGMENT HAVING FALLEN INSIDE THE PATIENT AT THAT TIME. THE CUSTOMER INITIALLY REPORTED THAT A STAPLER 45 INSTRUMENT WAS IN USE DURING THE PROCEDURE BUT IT WAS LATER CONFIRMED THAT IT WAS AN ENDOWRIST STAPLER 30 INSTRUMENT. THE SURGEON ATTRIBUTED THE CAUSE OF THE ISSUE AS BEING ¿USER ERROR FROM A SURGICAL TECH PUTTING THE STAPLER SHEATH ON THE INSTRUMENT THE WRONG WAY¿. THE SURGEON SAID THAT IT WAS "DIFFICULT TO UN

  Patient problems: Foreign Body In Patient

  MAUDE report 11173876 ↗
• InjuryNov 24, 2020Mechanical Problem; Mechanical Problem

  IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY, AN ENDOWRIST STAPLER 30 INSTRUMENT SUCCESSFULLY FIRED ONCE. UPON THE SECOND ATTEMPT TO USE THE ENDOWRIST STAPLER 30 INSTRUMENT, IT PASSED THROUGH THE TROCAR, SEATED IN THE CARRIAGE, AND THE SURGEON ASKED FOR IT TO BE REMOVED FOR AN UNKNOWN REASON. AS THE BEDSIDE ASSISTANT ATTEMPTED TO REMOVE THE INSTRUMENT FROM THE SYSTEM ARM, AN ERROR PRESENTED: "EMERGENCY RELEASE KIT MAY BE REQUIRED". THE PROCEDURE CONVERTED TO OPEN DUE TO ¿OTHER ISSUES." ON 2-NOV-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY, WHEN THE SURGEON WAS WORKING WITH THE LEFT RENAL VEIN, AN ENDOWRIST STAPLER 30 INSTRUMENT SUCCESSFULLY FIRED ONCE, WITH A WHITE RELOAD, BUT PRIOR TO THE SECOND ATTEMPT TO USE THE ENDOWRIST STAPLER 30 INSTRUMENT, IT PASSED THROUGH THE TROCAR, SEATED IN THE CARRIAGE, AND THE SURGEON ASKED FOR IT TO BE REMOVED FOR AN UNKNOWN REASON. AS THE BEDSIDE ASSISTANT ATTEMPTED TO REMOVE THE INSTRUMENT FROM THE SYSTEM ARM, AN ERROR PRESENTED: "EMERGENCY RELEASE KIT MAY BE REQUIRED". THE INSTRUMENT WAS REMOVED

  Patient problems: Blood Loss

  MAUDE report 10897117 ↗
• MalfunctionSep 18, 2020Difficult to Open or Close; Mechanical Jam; Difficult to Open or Close; Mechanical Jam

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10557436 ↗
• MalfunctionSep 18, 2020Difficult to Open or Close; Mechanical Jam; Difficult to Open or Close; Mechanical Jam

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER WAS UNABLE TO OPEN THE STAPLER 30 INSTRUMENT JAW. THE CUSTOMER USED THE STAPLER RELEASE KIT (SRK) TO OPEN THE JAWS AND REMOVED THE RELOAD. A BACKUP INSTRUMENT WAS USED TO PROCEED WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL (IS) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE STAPLER INSTRUMENT WAS NOT INSPECTED PRIOR TO USE. IT WORKED DURING THE SURGICAL PROCEDURE AND HAD BEEN USED FOR 1 HOUR BEFORE THE ISSUE OCCURRED. THE 4TH STAPLER FIRE WAS INVOLVED WITH THE REPORTED EVENT. NO ERRORS OR MESSAGES WERE GENERATED WHEN THE ISSUE OCCURRED. THE SURGEON DID NOT ENCOUNTER ANY OBSTRUCTIONS SUCH AS CLIPS, STAPLES, OR OTHER HARD MATERIAL BETWEEN THE INSTRUMENT JAWS AND NO BUTTRESS MATERIAL WAS USED. THERE WERE NO MALFORMED STAPLES. THE TARGET TISSUE WAS VESSEL WHICH WAS THE REASON WHY THE SURGEON SELECTED A WHITE RELOAD TO PERFORM THE SURGICAL TASK. THE TISSUE WAS NOT CALCIFIED AND WAS NOT EXPOSED TO ANY RADIATION OR CHEMOTHERAPY PRIOR TO THE PROCEDURE. THERE WAS NO TISSUE TENSION AND NO TISSUE BUNCHING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10557431 ↗
• MalfunctionMay 6, 2020Difficult to Open or Close

  AT THE END OF A ROBOTIC-ASSISTED LUNG RESECTION, THE DA VINCI SURGICAL STAPLER WOULD NOT OPEN AFTER STAPLING THE TISSUE. THE DA VINCI SURGICAL SYSTEM REPRESENTATIVE WAS CALLED AND THE DEVICE WAS UNLOCKED WITH A KEY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10028361 ↗