EndoWrist 410370Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00886874111130), received between Feb 21, 2020 and May 12, 2026 — classified as 8 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CURVED TIP STAPLER 30 MISFIRED. THE RELOAD WAS HALF DEPLOYED WITH BLADE EXPOSED MESSAGE. STAPLER HAD 5 LIVES LEFT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 25155493 ↗
• MalfunctionOct 29, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CURVED-TIP STAPLER INSTRUMENT WOULD NOT CONNECT TO UNIVERSAL SURGICAL MANIPULATOR (USM) OR THE USM DID NOT RECOGNIZE THE STAPLER. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23418344 ↗
• InjuryAug 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY, THE STAPLER SHEATH INSTALLED ON A CURVED-TIP STAPLER 30 INSTRUMENT TORE. THE CUSTOMER CONFIRMED THAT THE INSTRUMENT AND ACCESSORY WERE INSPECTED PRIOR TO USE, WITH NO DAMAGE OR ANYTHING UNUSUAL NOTED. THE ISSUE OCCURRED AFTER THE INSTRUMENT WAS INSERTED INTO THE THORACIC CAVITY, ROTATED FOR VESSEL LIGATION, AND THEN REMOVED. UPON FINAL REMOVAL, THE WRIST OF THE INSTRUMENT WAS STRAIGHTENED. ALTHOUGH IT WAS SUSPECTED THAT A FRAGMENT HAD FALLEN INSIDE THE PATIENT, IT COULD NOT BE FOUND UPON CHECKING. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT, AND NO POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22734282 ↗
• InjuryApr 2, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A FRAGMENT FROM A STAPLER SHEATH CAME OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21759243 ↗
• InjuryFeb 5, 2025Material Separation; Material Separation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21316168 ↗
• MalfunctionJun 6, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE THAT THE CURVED-TIP STAPLER 30 INSTRUMENT AND THE INSTALLED WHITE RELOAD WERE BEING FIRED ACROSS THE PULMONARY ARTERY (PA) WHEN THE STAPLER AND RELOAD DID NOT FIRE. NO STAPLES OR BLADE WERE DEPLOYED DURING THIS EVENT. IT WAS REPORTED THAT NO ERRORS WERE GENERATED DURING THIS EVENT. THERE ARE NO IMAGES OR VIDEOS OF THIS EVENT. THE PA WAS REPORTEDLY IN NORMAL CONDITION WITH NO TENSION NOR ANY OBSTRUCTIONS DURING THIS EVENT. THE SURGEON USED A LAPAROSCOPIC STAPLER INSTRUMENT TO CONTINUE THIS PROCEDURE TO COMPLETION WITH NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067519 ↗
• MalfunctionMay 27, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THIS STAPLER SHEATH WAS INCLUDED WITH SUREFORM 45 CURVED TIP STAPLER. THERE WAS NO CUSTOMER COMPLAINT AGAINST THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015524 ↗
• MalfunctionMay 27, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INSTRUMENT GOT STUCK IN TROCAR. 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 17015523 ↗
• MalfunctionMay 27, 2023Break; Detachment of Device or Device Component; Material Integrity Problem; Break; Detachment of Device or Device Component; Material Integrity Problem

  THE STAPLER SHEATH WAS RETURNED AS AN INCIDENT RETURN. THE UNIT WAS RETURNED WITH A STAPLER 45 INSTRUMENT. IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER NOTED A TUBE DEFECT ON THE STAPLER 45 INSTRUMENT. THE INSTRUMENT COULD NOT FIT INTO THE TROCAR. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION. THE INSTRUMENT WAS NOT USED ON THE PATIENT AND NO FRAGMENT FELL INTO THE PATIENT. THE OR STAFF USED A BACKUP INSTRUMENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INJURY TO THE PATIENT. NO PATIENT RELATED INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015517 ↗
• MalfunctionMay 13, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE STAPLES WOULD HALF WAY RELEASE, WOULD NOT CLAMP DOWN ALL THE WAY. 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 STAPLER CLAMPED AND UNCLAMPED THREE TIMES, BUT DID NOT FIRE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE; THE SURGEON ENCOUNTERED NO OBSTRUCTIONS SUCH AS CLIPS, STAPLES, OR OTHER HARD MATERIAL BETWEEN THE INSTRUMENT JAWS, AND NO TENSION IN THE JAWS. BUTTRESS WAS NOT USED. BOWEL WAS THE TARGET TISSUE. THE TISSUE WAS NOT CALCIFIED AND NOT EXPOSED TO ANY RADIATION OR CHEMOTHERAPY PRIOR TO THE PROCEDURE. THERE WAS NO TISSUE BUNCHING. THE PROCEDURE WAS COMPLETED WITH A SPARE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16927834 ↗
• InjuryMay 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, WHEN THE STAPLER INSTRUMENT WAS REMOVED FROM THE CANULA, THE DISPOSABLE STAPLER SHEATH ACCESSORY GOT DAMAGED IN 2 PIECES. A BACKUP ACCESSORY OF THE SAME TYPE WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE STAPLER SHEATH IS A SINGLE-USE DISPOSABLE ACCESSORY INTENDED TO COVER THE STAPLER WRIST AND THE LOWER SHAFT TO PREVENT TISSUE FROM BEING DRAWN INTO THE MOVING/ROTATING COMPONENTS OF THE INSTRUMENT. AN INSTALLATION TOOL (PACKAGED WITH THE SHEATH) AIDS IN INSTALLATION, REMOVAL AND REPOSITIONING OF THE SHEATH . INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER STATED A FRAGMENT OF THE DISPOSABLE STAPLER SHEATH ACCESSORY FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE STAPLER CANNULA WAS INSPECTED PRIOR TO USE WITH A GAUGE PIN WITH NO PROBLEMS FOUND. THE CUSTOMER STATED THE STAPLER INSTRUMENT WRIST WAS NOT STRAIGHT WHEN THE INSTRUMENT WAS REMOVED. PICTURES OF THE STAPLER INSTRUMENT AND SHEATH INVOLVED WITH THE COMPLAINT WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925242 ↗
• InjuryMay 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A DA VINCI-ASSISTED PROCEDURE THE STAPLER SHEATH FELL INSIDE THE PATIENT'S ANATOMY WHILE REMOVING THE STAPLER FROM THE PATIENT. THE STAFF RETRIEVED THE FRAGMENT FROM THE PATIENT DURING THE SAME PROCEDURE AND THE CASE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ROBOTIC SURGERY MANAGER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ROBOTIC SURGERY MANAGER SAID THE REPORTED INCIDENT OCCURRED DURING A ROBOTIC THORACOSCOPY FOR LOBECTOMY PROCEDURE. IT WAS NOTED THE STAPLER SHEATH AND THE STAPLER INSTRUMENT WERE INSPECTED PRIOR TO USE AND NO DAMAGE WAS OBSERVED. PRIOR TO THE STAPLER SHEATH FALLING INTO THE PATIENT, IT WAS NOTED THE INSTRUMENT AND ACCESSORY HAD BEEN FIRED 6 TIMES. AT THE TIME THE CUSTOMER OBSERVED THE STAPLER SHEATH TEAR, THE WRIST WAS SLIGHTLY FLEXED DURING THE REMOVAL OF THE INSTRUMENT, AND THE ASSISTANT NOTICED A SMALL TEAR ON THE SHEATH. IT WAS STATED THAT THE ASSISTANT THOUGHT IT WOULD BE OKAY TO KEEP USING THE STAPLER SHEATH. THE FIRST ASSIST INFORMED THE ROBOTIC SURGERY MANAGER THAT THE INSTRUMENT WAS MORE DIFFICULT TO REMOVE THAN USUAL. THE STAPLER INSTRUMENT WAS THEN RE-INSERTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925238 ↗
• MalfunctionMay 13, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE USER INSPECTED THE STAPLER SHEATH PRIOR TO USE AND FOUND A CRACK. ANOTHER STAPLER SHEATH WAS INSTALLED INTO THE STAPLER INSTRUMENT. FOLLOWING THIS, THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INTO THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925178 ↗
• MalfunctionMay 13, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE. THE SHEATH WAS DAMAGED FROM REMOVING THE STAPLER. IT WAS UNKNOWN, IF ANY FRAGMENT FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925175 ↗
• InjuryFeb 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE ENDOWRIST STAPLER SHEATH FELL INSIDE OF THE PATIENT. THE ITEM WAS SUCCESSFULLY RETRIEVED AND THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER NOTED A TEAR ALMOST COMPLETELY CIRCUMFERENTIALLY. THE PIECE WAS RETRIEVED WITH A DA VINCI CADIERE GRASPER. IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED; THE CUSTOMER PIECED TOGETHER THE COMPLETELY TORN SHEATH AND COMPARED IT TO A WHOLE SHEATH. NO ADDITIONAL SURGICAL PROCEDURE WAS NEEDED. THERE WERE NO POST-OPERATIVE TESTS PERFORMED. THE SURGEON IS NOT AWARE OF WHAT COULD HAVE CONTRIBUTED TO THE TEAR. THE ACCESSORY WAS INSPECTED PRIOR TO USE AND NO DEFECTS WERE NOTED. THE ISSUE WAS NOTED DURING THE INSTRUMENT REMOVAL. THERE WAS NO ISSUE WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS REMOVED PRIOR TO THE ACCESSORY TEAR AND THE WRIST WAS STRAIGHTENED AT THAT TIME WITH NO RESISTANCE THROUGH THE CANNULA REPORTED. UPON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13555497 ↗
• InjuryDec 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOWRIST STAPLER SHEATH TORE DURING USE WITH THE STAPLER UNIT INTRA OPERATIVELY. A SMALL PIECE OF PLASTIC FROM THE SHEATH WAS RETRIEVED FROM THE ABDOMINAL CAVITY DURING SURGERY. UPON INSPECTION BY THE SURGEON AND THE NURSE, ALL PIECES APPEAR TO HAVE BEEN ACCOUNTED FOR. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: RISK MANAGEMENT WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION. THEY CONFIRMED THAT THE PROCEDURE OCCURRED AT THE VAN NESS CAMPUS. CONTACT INFORMATION FOR THE NURSE AND SURGEON INVOLVED IN THE CASE WAS REQUESTED, HOWEVER RISK MANAGEMENT ELECTED TO NOT PROVIDE THAT INFORMATION.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12980453 ↗
• InjuryMay 22, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT AFTER SUCCESSFULLY COMPLETING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THE USER CONDUCTED AN INSPECTION AND FOUND A "DEFECT" ON THE DISPOSABLE STAPLER SHEATH. THE USER WAS UNSURE IF A FRAGMENT ACTUALLY FELL INSIDE THE PATIENT DURING INTRAOPERATIVE USE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE ISI CLINICAL SALES REPRESENTATIVE (CSR) REGARDING THE REPORTED EVENT: THERE WAS NO KNOWN ISSUE WITH THE STAPLER 45 INSTRUMENT DURING THE PROCEDURE. THE CUSTOMER WAS UNABLE TO CONFIRM IF A FRAGMENT FROM THE STAPLER SHEATH MAY HAVE FALLEN INSIDE THE PATIENT. X-RAY EXAMINATION WAS PERFORMED AFTER THE PROCEDURE AND FOUND NO VISIBLE RETAINED FRAGMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11868037 ↗
• MalfunctionFeb 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THERE WAS AN ISSUE WITH A FRAGMENT FALLING INTO THE PATIENT. THE CUSTOMER SAID THAT AFTER USING A STAPLER 45 INSTRUMENT, THE SURGICAL TEAM SAW THAT THE BLACK PART OF THE ENDOWRIST STAPLER SHEATH HAD FALLEN APART AND WAS INSIDE THE PATIENT¿S ABDOMINAL CAVITY AND THEY RETRIEVED IT DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ON 2/4/2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING A LOW ANTERIOR RESECTION (LAR) ON (B)(6) 2020, WHILE THE SURGEON WAS WORKING ¿ON RADIATED THICK TISSUE¿, THE SURGEON USED A STAPLER 30 INSTRUMENT WITH GREEN RELOADS ON THE THICK RADIATED TISSUE IN THE RECTUM. ONCE THE STAPLING WAS COMPLETED, THE SURGEON WENT TO TAKE OUT THE STAPLER 30 INSTRUMENT AND THAT¿S WHEN HE AND THE SURGICAL STAFF NOTICED A ¿CIRCULAR BLACK PLASTIC COVER¿ WITH A ¿SPLIT ON THE SIDE¿. THE SURGEON DETERMINED THAT IT LOOKED LIKE A STAPLER SHEATH. THE FULLY INTACT SHEATH WAS FOUND NEAR THE TROCAR ON THE UPPER RIGHT SIDE OF THE ABDOMEN. THE SURGEON FOLDED THE INTACT SINGLE PIECE AND SUCCESSFULLY EXT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9742511 ↗