SureForm 480545Recalls & reported problems

Summary

The FDA's MAUDE database contains 141 adverse event reports that list this exact device (DI 00886874117590), received between Aug 14, 2021 and Aug 10, 2026 — classified as 3 deaths, 28 injuries, 110 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (36 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. Mar 17, 2022Open, Classified

   As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected. Overall rate of harm associated with bleeding of critical severity exceeds the predicted likelihood of harm as documented within Intuitive s existing risk documentation.

   Z-0999-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 141 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2026Unintended System Motion

  It was reported that during a da Vinci-assisted pulmonary segmentectomy surgical procedure, a Curved-Tip SureForm 45 Stapler instrument would jerk after completing a fire. This complication occurred during the second stapler fire of the procedure. When the stapler was being fired, the stapler instrument ¿jerked¿ and tore the pulmonary artery (PA). The Clinical Sales Representative (CSR) later talked to the doctor¿s First Assist who said that they controlled the bleeding during this procedure by stapling the PA. The patient reportedly did well. The surgeon indicated that in his experience, it is normal for the da Vinci stapler to ¿jerk¿ while firing. The surgeon said that the jerking movement was not abnormal and it was not a malfunction of the instrument, but that he doesn¿t like that it moves because it can damage sensitive tissue. The procedure was completed robotically. A Technical Support Engineer (TSE) reviewed the logs for the case and did not see any errors associated with the reported issue.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50192809 ↗
• MalfunctionJun 17, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER WAS INSERTED INTO THE ROBOT WITHOUT ANY PROBLEM. WHEN GRASPING THE TISSUE, THE STAPLER LOST ITS GRIP. THE TISSUE SLID OFF AND REFUSED TO OPEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: AFTER THE STAPLER MALFUNCTIONED, WE TRIED OPENING HIM AGAIN THE USUAL WAY BY THE DA VINCI ROBOT. AFTER TRYING THIS FOR A FEW TIMES, THE CHOICE WAS MADE TO TAKE ANOTHER INSTRUMENT. THE RELEASE KIT WAS NOT USED TO TRY AND OPEN THE STAPLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25540934 ↗
• MalfunctionJun 9, 2026No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 45 CURVED TIP STAPLER INSTRUMENT HAD AN UNSPECIFIED ISSUE. THE DEVICE WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CONNECTION BETWEEN THE STAPLER AND THE ROBOT WAS IMPOSSIBLE, AS THE STAPLER WAS NOT RECOGNIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25451597 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE RANGE OF MOTION WAS MISJUDGED WHILE USING A SUREFORM 45 CURVED-TIP STAPLER WITH A SUREFORM 45 BLACK RELOAD, RESULTING IN INJURY TO THE PULMONARY VEIN AND SUBSEQUENT BLEEDING. THIS NECESSITATED A CONVERSION TO OPEN SURGERY TO ACHIEVE HEMOSTASIS, AFTER WHICH THE PROCEDURE WAS COMPLETED SUCCESSFULLY. DETAILS REGARDING WHAT SURGICAL TASK WAS BEING PERFORMED AT THE TIME OF THE EVENT, BLOOD LOSS VOLUME, HEMOSTASIS TECHNIQUES, AND ANY ADDITIONAL MEDICAL INTERVENTIONS REMAIN UNKNOWN. THE SURGEON DOES NOT BELIEVE THAT A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: Great Vessel Perforation

  MAUDE report 25225242 ↗
• InjuryMay 15, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE, THE SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT WAS BLOCKED ON A PULMONARY ARTERY AND COULD NOT BE UNBLOCKED. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. THERE WAS A DELAY OF MORE THAN 30 MINUTES. 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 25183705 ↗
• MalfunctionMay 13, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CLOSED THE SUREFORM 45 CURVED TIP STAPLER INSTRUMENT ON TISSUE AND WHEN THE SURGEON WENT TO FIRE THE STAPLER, THE STAPLER OPENED AND THEN WOULD NOT MOVE AGAIN. 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 CUSTOMER STATED THE JAWS OPENED WHEN THE SURGEON ACTIVATED THE STAPLER WHICH WAS THE MAIN MALFUNCTION. THE JAWS WERE NOT STUCK ON TISSUE. NO ADVERSE EFFECTS TO TISSUE AND NO UNEXPECTED TISSUE REMOVAL. NO BLEEDING WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25165191 ↗
• InjuryMay 6, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE RUBBER SLEEVE THAT COVERS THE HINGE OF THE CURVED-TIP SUREFORM 45 STAPLER INSTRUMENT BUNCHED UP AND WOULD NOT ALLOW THE STAPLER TO COME OUT. FRAGMENT FELL INTO THE PATIENT. THE USER COMPLETED THE PROCEDURE AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25090199 ↗
• InjuryApr 27, 2026Material Separation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE BLACK SLEEVE COVERING THE ARTICULATING PART ON THE SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT BROKE INSIDE PATIENT. A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT WAS INSPECTED PRIOR TO USE, WITH NO DAMAGE OR ABNORMALITIES OBSERVED. DURING INSTRUMENT REMOVAL, A FRAGMENT FELL INSIDE THE PATIENT; THE CAUSE IS UNKNOWN, AND NO EXCESSIVE FORCE, COLLISIONS, OR MISUSE WERE REPORTED. THE INSTRUMENT FUNCTIONED AS EXPECTED THROUGHOUT THE PROCEDURE, AND THE WRIST WAS STRAIGHTENED BEFORE REMOVAL. THE FRAGMENT WAS VISUALIZED AND RETRIEVED INTRAOPERATIVELY WITH A LAPAROSCOPIC GRASPER. NO EXTRA SURGICAL PROCEDURES OR POSTOPERATIVE IMAGING WERE REQUIRED, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY AS PLANNED WITHOUT PATIENT INJURY OR POST-SURGICAL COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009268 ↗
• InjuryApr 21, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT REMAINED CLOSED AND WAS NOT POSSIBLE TO CLAMP OR FIRE DURING THE FIRST FIRING ATTEMPT. THIS ISSUE WAS REPORTED TO NOT BE RELATED TO TISSUE THICKNESS. THE CUSTOMER REMOVED THE INSTRUMENT WITHOUT IT MAKING ANY FIRING AFTER THE JAWS WERE OPENED NORMALLY. THE SUREFORM 45 STAPLER WAS NOT USED AGAIN. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY AFTER THE FIRST PORT INCISION DUE TO THE COMPLEXITY OF THE CASE AND SURGEON DECISION BASED ON EXPERIENCE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24939688 ↗
• MalfunctionApr 14, 2026Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879014 ↗
• MalfunctionApr 9, 2026Difficult to Open or Close

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24834582 ↗
• MalfunctionApr 8, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CUSTOMER LOST CONTROL OF THE CURVED-TIP SUREFORM 45 STAPLER INSTRUMENT ON UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND FOUND NO FAULTS FOR USM 4. THE CUSTOMER WAS STAPLING AND WAS DONE CLAMPING AND THEN LOST CONTROL OF THE INSTRUMENT. SUBSEQUENTLY, THE CUSTOM PRESSED THE INSTRUMENT CLUTCH BUTTON, REENGAGED THE CLUTCH, AND WERE ABLE TO FINISH STAPLING. THE CUSTOMER HAS SINCE USED SEVERAL INSTRUMENTS AND THE STAPLER AGAIN, WITH NO ADDITIONAL ISSUES WITH USM 4. THE CUSTOMER CONTINUED WITH THE CASE. THE USER COMPLETED THE PROCEDURE AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821392 ↗
• MalfunctionApr 2, 2026Break

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 45 CURVED TIP STAPLER HAD A CRACK IN THE RUBBER PART OF THE TIP OF THE INSTRUMENT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772346 ↗
• MalfunctionMar 30, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE JAWS OF THE SUREFORM 45 STAPLER INSTRUMENT ON UNIVERSAL SURGICAL MANIPULATOR (USM3) WAS INTERMITTENTLY FAILING TO OPEN AND CLOSE. TECHNICAL SUPPORT ENGINEER (TSE) ADVISED RESEATING BOTH THE DRAPE AND THE INSTRUMENT; HOWEVER, THE STAFF CHOSE NOT TO PERFORM THESE STEPS DURING THE CALL. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716420 ↗
• MalfunctionMar 10, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 45 CURVED TIP STAPLER INSTRUMENT JAWS LOCKED UP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE FOLLOWED UP AND OBTAINED ADDITIONAL INFORMATION. THE CUSTOMER INFORMED THE INSTRUMENT WAS INSPECTED PRIOR TO USE. NO DAMAGE OUT OF THE ORDINARY. A BRONCHOSCOPY WITH LEFT SIDED ROBOTIC ASSISTED THORACOSCOPY, LEFT LOWER LOBECTOMY AND MEDIASTINAL LYMPH NODE DISSECTION WAS BEING PERFORMED. THE ISSUE DID NOT OCCUR AFTER A FAULT. TARGET TISSUE WAS THE LUNGS. THE JAWS WERE NOT STUCK ON TISSUE. THERE WAS NO BLEEDING. THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563536 ↗
• MalfunctionMar 9, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON WAS NOT ABLE TO ARTICULATE THE STAPLER ALONG THE FISSURE OF THE LUNG PROPERLY. THE SURGEON TRIED TO STRAIGHTEN THE STAPLER FOR THE ASSIST TO REMOVE HOWEVER THE ARTICULATING JOINT WAS CAUGHT ON THE PORT CANNULA. ONCE REMOVED, THE SCRUB NURSE INSPECTED THE STAPLER AND NOTICED A TEAR ALONG THE BLACK JOINT COVER AND THE STAPLER WAS REMOVED FROM THE FIELD AND REPLACED WITH A NEW STAPLER. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. NO FRAGMENTS FELL INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542442 ↗
• InjuryFeb 11, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THORACIC PROCEDURE, A PIECE OF A SUREFORM 45 STAPLER INSTRUMENT BROKE AND FELL INTO THE PATIENT. THE STAPLER WOULD NOT ADVANCE FULLY THROUGH THE TROCAR AND THERE WAS ADDITIONAL DIFFICULTY WHEN ATTEMPTING TO REMOVE THE DEVICE. THE STAPLER WAS NOT ON TISSUE AND WAS NOT USED PRIOR TO BEING REMOVED COMPLETELY FROM THE PATIENT. ONCE REMOVED, THE TEAM AT THE SURGICAL FIELD INSPECTED THE DEVICE AND NOTICED A PIECE SEEMED TO BE MISSING FROM THE "SHEATH" AT THE WRIST OF THE STAPLER. THE STAPLER WAS NOT BEING FIRED WHEN THE PIECE FELL INTO THE PATIENT, AND IT DID NOT FALL DURING A COLLISION. IT WAS UNCLEAR HOW/IF THE FRAGMENT THAT FELL INTO THE PATIENT WAS RETRIEVED. AN UNSPECIFIED "OTHER" POST-OPERATIVE TEST WAS PERFORMED. THE PROCEDURE WAS COMPLETED AS PLANNED. ON 09-FEB-2026, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT (B)(4) STATING: "DURING A ROBOTIC THORACIC PROCEDURE, A DISPOSABLE ROBOTIC STAPLER WAS BEING PLACED. THE STAPLER WOULD NOT ADVANCE FULLY THROUGH THE TROCAR AND THERE WAS ADDITIONAL DIFFICULTY WHEN ATTEMPTING TO REMOVE THE DEVICE. THE STAPLER WAS NOT ON TISSUE AND WAS NOT USED PRIOR TO BEING REMOVED COMPLETELY

  Patient problems: Foreign Body In Patient

  MAUDE report 24313362 ↗
• MalfunctionFeb 9, 2026

  DURING A ROBOTIC THORACIC PROCEDURE, A DISPOSABLE ROBOTIC STAPLER WAS BEING PLACED. THE STAPLER WOULD NOT ADVANCE FULLY THROUGH THE TROCAR AND THERE WAS ADDITIONAL DIFFICULTY WHEN ATTEMPTING TO REMOVE THE DEVICE. THE STAPLER WAS NOT ON TISSUE AND WAS NOT USED PRIOR TO BEING REMOVED COMPLETELY FROM THE PATIENT. ONCE REMOVED, THE TEAM AT THE SURGICAL FIELD INSPECTED THE DEVICE AND NOTICED A PIECE SEEMED TO BE MISSING FROM THE "SHEATH" AT THE WRIST OF THE STAPLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291366 ↗
• MalfunctionFeb 3, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER INSTRUMENT COULD NOT BE TRIGGERED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM, ADVERSE OUTCOME OR INJURY. THE ISSUE CAUSED A DELAY OF LESS THAN 15 MINUTES. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE FOLLOWED UP AND OBTAINED ADDITIONAL INFORMATION. IT WAS A PARTIAL TRIGGERING OF THE STAPLER. AFTER INITIALLY CLOSING WITHOUT ANY WARNINGS, THE STAPLER SUDDENLY GOT "STUCK" ABOUT HALFWAY THROUGH AND CONTINUED TO COMPRESS FOR A VERY LONG TIME, EVEN THOUGH THE PARENCHYMA WAS OBVIOUSLY NOT PARTICULARLY THICK. A MESSAGE THEN APPEARED STATING THAT THE TISSUE WAS TOO THICK, AND AFTER CONFIRMATION, THE STAPLER RETRACTED AND OPENED. IT WAS NOT POSSIBLE TO REMOVE THE MAGAZINE FROM THE STAPLER. A NEW STAPLER CONTINUED TO STAPLE THE PARENCHYMA IN THE SAME PLACE WITHOUT ANY PROBLEMS. THE INCIDENT WAS RECORDED ON VIDEO AND CAN BE VIEWED IF NECESSARY. INTUITIVE FOLLOWED UP AND OBTAINED ADDITIONAL INFORMATION. AFTER THE STAPLER WAS OPENED, THERE WERE STILL STAPLES IN THE MAGAZINE. SOME STAPLES IN THE STAPLER SEAM WERE ALSO NOT STAPLED, BUT STILL 'OPEN'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250816 ↗
• MalfunctionDec 30, 2025Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23928514 ↗
• MalfunctionDec 4, 2025Unintended System Motion; Unintended System Motion

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720811 ↗
• MalfunctionNov 13, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROCEDURE THE STAPLER FAILED TO DEPLOY. THE INSERT WAS FOUND TO BE JAMMED IN THE MECHANISM AFTER DEPLOYMENT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23539726 ↗
• DeathNov 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT UPPER PULMONARY LOBECTOMY, THE AORTA WAS INADVERTENTLY TORN, RESULTING IN HEMORRHAGE AND THE PATIENT¿S DEATH. THE SURGEON INFORMED THE INTUITIVE AREA SALES MANAGER THAT THE INCIDENT OCCURRED WHILE POSITIONING A SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT WITH A GREEN RELOAD POSTERIORLY BETWEEN THE UPPER AND LOWER LOBES. ATTEMPTS TO CONTROL THE HEMORRHAGE USING THE ROBOTIC INSTRUMENTS TO APPLY PRESSURE WERE UNSUCCESSFUL; THE BLEEDING WAS TOO SEVERE TO BE MANAGED ROBOTICALLY, NECESSITATING CONVERSION TO AN OPEN THORACOTOMY. MANUAL COMPRESSION WAS APPLIED DIRECTLY BUT THE BLEEDING COULD NOT BE CONTROLLED. THE PATIENT DEVELOPED HYPOVOLEMIC SHOCK AND SUBSEQUENTLY EXPIRED. THE SURGEON STATED THAT THE CAUSE OF THE EVENT INCLUDED: "TECHNICAL MISTAKE WITH [SUREFORM 45 CURVED-TIP INSTRUMENT] STAPLER, NO VISIBILITY TO BEHIND THE AORTA" AND THE CONTRIBUTING FACTOR IS "BECAUSE NO FORCE FEEDBACK WHICH MAY PREVENT STAPLER TO PUNCTURE THE AORTA. WITHOUT FORCE FEEDBACK EXCESSIVE FORCE CAN BE APPLIED." THE SURGEON CONFIRMED THAT "THERE WAS NO ISSUE WITH THE ROBOT OR THE ENDOSCOPE ITSELF", AND "WAS AWARE THERE IS NO HAPTIC FEEDBACK."

  Patient problems: Great Vessel Perforation; Hemorrhage/Blood Loss/Bleeding; Hypovolemic Shock

  MAUDE report 23483094 ↗
• MalfunctionOct 30, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE, THE CURVED TIP SUREFORM 45 STAPLER INSTRUMENT WAS USED IN THREE FIRES AND WORKED AS INTENDED. DURING THE FOURTH FIRE, THE CUSTOMER USED A WHITE RELOAD AND WHEN THE CURVED TIP SUREFORM 45 STAPLER INSTRUMENT WAS CLOSED (ARTERY BETWEEN THE JAWS, NOT CLAMPED YET), THE SURGEON SUDDENLY LOST CONTROL OF THE INSTRUMENT AND IT STARTED MOVING UPWARD. USE OF THE INSTRUMENT WAS DISCONTINUED, AND IT WAS REPLACED TO THE BACKUP. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23429712 ↗
• MalfunctionOct 29, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROCEDURE, A CUSTOMER WHILE USING THE STAPLER SUREFORM 45 CURVED WITH A WHITE VASCULAR RELOAD, THE CLAMP FUNCTION WAS INITIATED AND COMPLETED SUCCESSFULLY. HOWEVER, DURING THE FIRING SEQUENCE, A "PAUSE FOR COMPRESSION" OCCURRED, AND THE STAPLER WAS UNABLE TO COMPLETE THE FIRING CYCLE DUE TO "TOO THICK TISSUE". THE STAPLER WAS THEN REMOVED, A NEW VASCULAR RELOAD WAS INSERTED, AND THE FIRING PROCESS WAS REPEATED. THE SECOND ATTEMPT WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM, ADVERSE OUTCOME OR INJURY AND WITH A DELAY OF LESS THAN 15 MINUTE. INTUITIVE SURGICAL (IS) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE REPORTER CONFIRMED THAT THE TARGET ISSUE WAS THE PULMONARY VEIN OF THE UPPER LOBE. THERE WAS NO TISSUE TENSION NOR TISSUE BUNCHING. THERE WERE NO MALFORMED STAPLES OBSERVED. THE RELOAD DID NOT HAVE AN EXPOSED BLADE. NO HOLES OR GAPS WERE OBSERVED IN THE STAPLE LINE. THE RELOAD APPEARED TO HAVE BECOME STUCK ON THE TISSUE, AS THE DEVICE DISPLAYED THE MESSAGE "TISSUE TOO THICK" AND THE FIRING CYCLE WAS NOT FULLY COMPLETED. THE SUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23420436 ↗