SureForm 480460Recalls & reported problems

Summary

The FDA's MAUDE database contains 409 adverse event reports that list this exact device (DI 00886874115640), received between Dec 5, 2018 and Sep 24, 2026 — classified as 1 death, 84 injuries, 324 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (149 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 409 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026No Apparent Adverse Event

  Patient problems: Insufficient Information

  MAUDE report 50890791 ↗
• MalfunctionAug 11, 2026Break

  It was reported that during a da Vinci-assisted distal gastrectomy surgical procedure, the Sureform 60 Stapler could not be removed due to the rubber cover breaking and blocking the entry into the trocar. The user was completing the procedure as planned with no further issue reported. No fragment fell inside the patient. No known impact or patient consequence was reported. Intuitive followed up with the initial reporter and obtained the following additional information: The instrument was inspected prior to use with no damage found. There was no instrument collision during the procedure. There was no fragment fall into the patient. The instrument was removed with the trocar.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50205144 ↗
• InjuryJul 31, 2026Use of Device Problem; Firing Problem

  It was reported that during a da Vinci-assisted sleeve gastrectomy procedure, the SureForm 60 Stapler instrument was removed by a scrub tech student while firing a SureForm 60 Blue Reload which resulted in a partial fire. This event on the second to last staple fire when the scrub tech student attempted to remove the stapler from the Universal Surgical Manipulator (USM). As a result, the stapler instrument stopped mid fire and an error message of "blade exposed" was populated. The stapler instrument was also pulling aggressively towards the lower abdomen so the surgeon had to re-engage the instrument in order for the USM to register the instrument. The instrument release key was used to manually open the jaws of the stapler instrument to release the tissue. The surgeon commented that it took a long time with a good amount of turning of the key, before it actually opened. Once opened, only half of the tissue was stapled. The surgeon used a new stapler instrument and reload to staple adjacent to the original attempted staple line. The partially fired tissue was excised with the previously fired staples as a portion of the specimen. The surgeon reports there was no bleeding. Post-oper

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50105485 ↗
• InjuryJun 18, 2026Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THE SUREFORM 60 STAPLER WITH THE BLUE RELOAD INSTALLED WAS UNABLE TO COMPLETE ITS FIRST FIRING. THERE WAS A BLADE MAY BE EXPOSED MESSAGE. THE STAPLER JAWS BECAME STUCK, AND A MANUAL RELEASE KEY WAS USED TO OPEN THE INSTRUMENT. AFTER THE STAPLER WAS OPENED AND REMOVED FROM THE TISSUE, THE BLADE WAS OBSERVED TO BE EXPOSED IN THE BLUE RELOAD. THERE WERE NO MALFORMED STAPLES. TISSUE WAS NOT PUSHED FORWARD/DRAGGED. THE SURGEON THEN CLEARED ADDITIONAL MESORECTUM BELOW THE INCOMPLETE/PARTIAL STAPLE LINE AND COMPLETED THE TRANSECTION USING ANOTHER SUREFORM 60 STAPLER. NO BLEEDING WAS REPORTED, AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25552166 ↗
• MalfunctionMay 13, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER WOULD NOT RELEASE THE TISSUE APPROPRIATELY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163011 ↗
• MalfunctionMay 9, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT HEMICOLECTOMY SURGICAL PROCEDURE, IT WAS NOTED THAT WHEN CUSTOMER WANTED TO REMOVE THE SUREFORM 60 STAPLER, THERE WASN'T READBACK BETWEEN SURGEONS. THEN THE JAWS WERE FOLDED. AND THEY USED MANUAL RELEASED KNOB. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 16-FEB-2026: THE SUREFORM 60 STAPLER WAS INSPECTED PRIOR TO USE. THE JAWS WERE NOT STUCK ON TISSUE AT THE TIME OF THE EVENT. THE MANUAL RELEASE KIT (MRK) WORKED. THERE WAS NO BLEEDING AS A RESULT OF THE FAILURE. NO IMAGES WERE AVAILABLE FOR REVIEW.

  Patient problems: Insufficient Information

  MAUDE report 25131722 ↗
• MalfunctionApr 28, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED THEY HAD AN ISSUE WITH THE STAPLER ON ARM 1. THE STAPLER WAS NOT RECOGNIZED, AND THEN THE STAPLER FLIPPED WHEN IT WAS RECOGNIZED. THE CUSTOMER HAD TO UNDOCK AND ROTATE ARM BACK. STAPLER FLIPPED ON ITS OWN. CUSTOMER CONFIRMED IT WAS AN ONGOING ISSUE WITH THE STAPLER. TSE VIEWED LOGS AND NO ASSOCIATED ERRORS WERE NOTED. FSE TO FOLLOW UP. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 25019776 ↗
• MalfunctionApr 27, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ILEOCECAL RESECTION SURGICAL PROCEDURE, THE CUSTOMER REPORTED THEY HAD AN ISSUE WITH THE STAPLER ON ARM 1. THE STAPLER WAS NOT RECOGNIZED, AND THEN THE STAPLER FLIPPED WHEN IT WAS RECOGNIZED. THE CUSTOMER HAD TO UNDOCK AND ROTATE ARM BACK. STAPLER FLIPPED ON ITS OWN. CUSTOMER CONFIRMED IT WAS AN ONGOING ISSUE WITH THE STAPLER. TSE VIEWED LOGS AND NO ASSOCIATED ERRORS WERE NOTED. FSE TO FOLLOW UP. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25010282 ↗
• MalfunctionApr 23, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER INSTRUMENT ARTICULATING COMPONENT CRACKED, BUT NO FOREIGN OBJECTS IN PATIENT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24974380 ↗
• MalfunctionApr 17, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER KEPT ASKING FOR THE CLAMP GRIP AFTER CLOSING. IT ALSO DID NOT ASK FOR THE COLOR WHEN CONNECTING. HELP FROM A SECOND SURGEON AND DIGITAL ASSISTANCE FROM INTUITIVE BUT REMAINED UNCOOPERATIVE. EVENTUALLY, STACKING WAS DONE WITH A MANUAL ECHELON. THE PROCEDURE WAS CONVERTED WITH NO REPORTED INJURY. THERE WAS A DELAY OF LESS THAN 15 MINUTES. INTUITIVE FOLLOWED UP AND OBTAINED ADDITIONAL INFORMATION. PROCEDURE WAS CONVERTED TO LAPAROSCOPY DUE TO INSTRUMENT FAILURE. PATIENT TOLERATED THE CONVERSION. INSTRUMENT WAS INSPECTED PRIOR TO USE. NO DAMAGE OUT OF THE ORDINARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916256 ↗
• MalfunctionApr 17, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A TEAR WAS OBSERVED IN THE RUBBER TIP OF THE FORCEPS WHILE USING THE SUREFORM STAPLER 60. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) EXPLAINED THAT CONTINUED USE OF THE FORCEPS IN QUESTION WAS NOT RECOMMENDED FROM A SAFETY STANDPOINT, AND THE SOLUTION WAS TO REPLACE THEM WITH NEW ONES AND RETURN THE DEFECTIVE ONES. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24906695 ↗
• MalfunctionApr 16, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER INSTRUMENT STOPPED MID-FIRE, AND AN ERROR MESSAGE APPEARED. THE SURGEON WAS ABLE TO RELEASE THE TISSUE BEING DIVIDED AND THE BEDSIDE ASSIST REMOVED THE STAPLER FROM THE CANNULA. THE DEFECTIVE STAPLE LOAD WAS REMOVED FROM THE JAWS OF THE STAPLER. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24903612 ↗
• MalfunctionApr 10, 2026Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PIECE OF SILICONE CAME OFF THE SHEATH ON THE SUREFORM 60 STAPLER. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CUSTOMER BUT WAS UNABLE TO OBTAIN ANY ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24842376 ↗
• MalfunctionApr 8, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) SURGICAL PROCEDURE, THE SUREFORM 60 INSTRUMENT STOPPED FUNCTIONING AFTER THE INSTALLATION OF A FOURTH SUREFORM 60 STAPLER RELOAD. POSITION IN REVERSE IN THE ABDOMEN. THE SUREFORM 60 INSTRUMENT WAS REMOVED, THEN THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS RESET VIA THE TROCAR BUTTON. THE SUREFORM 60 INSTRUMENT WAS LONGER RECOGNIZED. A MESSAGE WAS DISPLAYED NOT ENGAGED, WHILE THE OTHER STAPLERS FUNCTIONED CORRECTLY AND WERE RECOGNIZED. THE CUSTOMER COMPLETED THE PROCEDURE AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE INSTRUMENT WAS MOVING IN AN UNDESIRED DIRECTION. THE DESIRED DIRECTION WAS RIGHT, BUT IT WAS MOVING TO THE LEFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24815721 ↗
• MalfunctionMar 31, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER INSTRUMENT MALFUNCTIONED DURING THE 4TH RELOAD WHERE THE RELOAD COLOR WAS CHANGED FROM BLACK TO GREEN. THE COLOR WAS NOT RECOGNIZED, AND THEN THE STAPLER INSTRUMENT APPEARED TO BE REVERSED IN THE ABDOMEN (PELVIC MODE ON THE PATIENT'S LEFT SIDE). THE CUSTOMER REMOVED THE SUREFORM 60 STAPLER INSTRUMENT AND RESEATED THE ARM BY PRESSING THE TROCAR BUTTON AT ARM 3. FROM THAT POINT ON, THE SUREFORM 60 STAPLER INSTRUMENT WAS UNRECOGNIZABLE. THE DA VINCI SYSTEM KEPT ASKING THE CUSTOMER TO REMOVE AND REPLACE THE INSTRUMENT. THE CUSTOMER TRIED ANOTHER SUREFORM 60 STAPLER INSTRUMENT WHICH WAS RECOGNIZED PERFECTLY. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM OR INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24746102 ↗
• MalfunctionMar 25, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER INSTRUMENT WAS INSERTED AND WAS UNABLE TO CLOSE ON THE TISSUE. THE SUREFORM 60 STAPLER INSTRUMENT WAS REMOVED AND REINSERTED, BUT THE INSTRUMENT WENT THE OPPOSITE WAY OF THE TRACK LINES. THE CUSTOMER COMPLETED THE PROCEDURE AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690967 ↗
• InjuryMar 25, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE STAPLER "COULD NOT BE OPENED AFTER THE STACKING PROCESS". DURING THE SECOND FIRE USING THE SUREFORM 60 STAPLER INSTRUMENT, THE JAWS OF THE INSTRUMENT WOULD NOT OPEN WHILE STUCK ON TISSUE AFTER FIRING A BLUE RELOAD. THIS OCCURRED WITH THE SECOND FIRE OF THIS STAPLER INSTRUMENT. THE MESSAGE "TISSUE TOO THICK" APPEARED FOLLOWING AN ABORTED CLAMP ATTEMPT. THE TISSUE WAS CAREFULLY PUSHED OUT OF THE CLOSED JAWS WITH NO REPORTS OF TISSUE DAMAGE. THE PROCEDURE WAS COMPLETED AS PLANNED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24686390 ↗
• InjuryMar 25, 2026Material Fragmentation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24683994 ↗
• InjuryMar 17, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS (ROUX-EN-Y) PROCEDURE, A FRAGMENT FROM A SUREFORM STAPLER 60 INSTRUMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED AND THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO POST-SURGICAL COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619746 ↗
• MalfunctionMar 16, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SUBTOTAL GASTRECTOMY SURGICAL PROCEDURE, THE INTUITIVE CLINICAL TERRITORY ASSOCIATE (CTA) REPORTED THAT THEY HAD A SUREFORM 60 STAPLER INSTRUMENT THAT WOULD NOT OPEN THE JAWS. PRIOR TO CALLING IN, THE CTA REPORTED THAT THEY HAD MOVED TO ANOTHER STAPLER INSTRUMENT TO CONTINUE WITH THE PROCEDURE. THE INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) FOUND STAPLER RECOGNITION ERRORS IN LOGS. THE TSE RECOMMENDED THE CALLER TO RETURN THE AFFECTED INSTRUMENT FOR FAILURE ANALYSIS. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24612126 ↗
• MalfunctionMar 11, 2026No Device Output; Unintended Movement

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574922 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER INSTRUMENT SHEATH WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566026 ↗
• MalfunctionMar 9, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER GOT STUCK IN THE CANNULA AND THE CUSTOMER WAS UNABLE TO REMOVE IT EASILY FROM THE SYSTEM. ONCE THE CUSTOMER REMOVED REMOVE THE SUREFORM 60 STAPLER INSTRUMENT, IT RIPPED THE SHEATH ON THE SUREFORM 60 STAPLER INSTRUMENT, AND IT WAS UNUSABLE. NO 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 24552421 ↗
• MalfunctionMar 4, 2026Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGERY SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER JAWS OPENED DURING THE FOURTH STAPLING ATTEMPT. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FIRST STAPLER ISSUE OCCURRED DURING THE ATTEMPT TO FIRE WHILE THE JAWS WERE ENGAGED WITH TISSUE. THE SECOND STAPLER WAS OUTSIDE OF THE PATIENT WHEN THE ISSUE OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 24505091 ↗
• MalfunctionMar 4, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OTHER GENERAL SURGERY SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER JAWS OPENED IMMEDIATELY BEFORE CLAMPING ONTO TISSUE. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. INTUITIVE FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FIRST STAPLER ISSUE OCCURRED DURING THE ATTEMPT TO FIRE WHILE THE INSTRUMENT JAWS WERE ENGAGED WITH TISSUE. THE SECOND STAPLER WAS OUTSIDE OF THE PATIENT WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24504959 ↗