SureForm 480445Recalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 00886874117583), received between May 15, 2020 and Sep 25, 2026 — classified as 20 injuries, 95 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (54 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 115 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break; No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905856 ↗
• MalfunctionSep 24, 2026Difficult to Open or Close

  It was reported that during a da Vinci-assisted Low Anterior Resection surgical procedure, a SureForm 45 Stapler instrument would not dislodge from patient and got stuck on the Universal Surgical Manipulator (USM). The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887893 ↗
• MalfunctionJun 9, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE JAWS OF A SUREFORM 45 STAPLER INSTRUMENT WOULD NOT OPEN AND UNABLE TO SELECT THE COLOR OF THE MAGAZINE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25446761 ↗
• MalfunctionMay 27, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER HAD AN ERROR WHILE UNCLAMPING. THE CUSTOMER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE ISSUE WAS RELATED TO A SYSTEM ARM. HOWEVER, BASED ON THE ERROR MESSAGES THAT OCCURRED AT THE TIME OF THE EVENT, IT WAS SUGGESTED BY TECHNICAL SUPPORT TO SEND THE INSTRUMENT BACK FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25304505 ↗
• MalfunctionMay 5, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE JAWS WOULD NOT UNCLAMP ON THE SUREFORM 45 STAPLER. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS ARE AVAILABLE REGARDING THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084565 ↗
• InjuryApr 21, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOWER ANTERIOR RESECTION PROCEDURE, WHILE USING A SUREFORM 45 STAPLER, A SMALL BLACK RUBBER PIECE WAS OBSERVED IN THE ABDOMEN AND RETRIEVED DURING THE SAME PROCEDURE. THE ORIGIN OF THE FRAGMENT WAS UNKNOWN. ABDOMEN INSPECTION AND POST-OPERATIVE X-RAY CONFIRMED NO ADDITIONAL FRAGMENTS; ONLY A PRIOR SURGICAL RIGHT EPIGASTRIC CLIP AND CATHETER WERE NOTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER FOR ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS WERE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940167 ↗
• MalfunctionMar 16, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER JAWS OPENED AND CLOSED BY ITSELF AFTER LOADING THE SECOND RELOAD. THE CUSTOMER 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24609318 ↗
• InjuryMar 11, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT LOWER LOBE WEDGE RESECTION PROCEDURE, AN SUREFORM 45 STAPLER INSTRUMENT INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR (USM) #1 WOULD NOT UNCLAMP AFTER BEING FIRED. AS A RESULT, THE PORT WAS UPSIZED TO 12 MILLIMETERS AND CHANGED TO USM #4 TO FINISH STAPLING. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) RECEIVED MEDWATCH REPORT (MDR) WITH USER FACILITY/IMPORTER REPORT #(B)(4) STATING: "DAVINCI ARM #1 WAS BEING USED FOR STAPLING, BUT THE CLAMP WOULD NOT RELEASE AFTER BEING FIRED. THE PORT WAS UPSIZED TO 12 MILLIMETER AND CHANGED TO ARM #4 TO FINISH STAPLING." THE FOLLOWING INFORMATION IS UNKNOWN: HOW THE STAPLER INSTRUMENT WAS ULTIMATELY REMOVED, IF THERE WAS ANY DAMAGE/INJURY TO TISSUE DUE TO THE UNCLAMPING ISSUE, AND IF ANY SURGICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE CUSTOMER REPORTED FAILURE. ISI HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 24574847 ↗
• MalfunctionMar 6, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER INSTRUMENT MISFIRED. THE USER COMPLETED THE PROCEDURE AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE FOLLOWED UP AND OBTAINED ADDITIONAL INFORMATION: THE EVENT DID NOT INVOLVE A FAILURE TO FIRE OR A PARTIAL FIRE. THE EVENT DID NOT INVOLVE TISSUE BEING PUSHED FORWARD/DRAGGED DURING THE FIRING PROCESS. THE EVENT DID NOT INVOLVE THE STAPLER JAWS OPENING/RELEASING DURING THE FIRING SEQUENCE. THERE WERE NO MALFORMED OR UNFORMED STAPLES IN THE STAPLE LINE. THE RELOAD WAS NOT STUCK TO TISSUE. THERE WERE NO STAPLES MISSING FROM THE STAPLE LINE. THERE WERE NO HOLES/GAPS OBSERVED WITHIN THE STAPLE LINE. THE GREEN RELOAD WAS INSERTED, AUTOMATICALLY SELECTED THE BLUE RELOAD, AND WOULD NOT CHANGE. ONCE THE STAPLER WAS REMOVED, THE JAWS WERE LOCKED. A GREEN AND BLUE RELOAD WAS INVOLVED WITH THE REPORTED EVENT. THE SURGEON WAS ABLE TO RESOLVE THE ISSUE WITH A NEW STAPLER. THERE WAS NO BLEEDING OBSERVED ON THE STAPLE LINE DUE TO THE STAPLER ISSUE. THE SURGEON DID NOT ENCOUNTER ANY OBSTRUCTIONS SUCH AS CLIPS, STAPLES, OR OTHER HARD MATERIAL BETWEEN THE INSTRUMENT JAWS OR FIRE OVER AN EXIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24538984 ↗
• MalfunctionFeb 6, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER INSTRUMENT PROMPTED A MESSAGE TO SELECT THE RELOAD COLOR. THE CUSTOMER QUESTIONED IF THE INSTRUMENT WAS FULLY OPENED BECAUSE THERE WAS AN UNUSUAL MOVEMENT AND A SUSPECTED INCOMPLETE OPENING. THE CUSTOMER REMOVED THE INSTRUMENT AND VISUALLY INSPECTED THE INSTRUMENT WITH NO ISSUES OBSERVED. THE CUSTOMER REUSED THE INSTRUMENT, BUT THE SURGEON WAS STILL SUGGESTING THAT THE INSTRUMENT WAS NOT OPENING PROPERLY. THE PROCEDURE WAS COMPLETED USING A BACKUP SUREFORM STAPLER WITH NO FURTHER ISSUE REPORTED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283895 ↗
• MalfunctionJan 13, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER USED THE SUREFORM 45 STAPLER INSTRUMENT ONCE AND IT WORKED AS INTENDED. THE CUSTOMER WENT TO RELOAD FOR THE NEXT STAPLE, AND THE JAWS OF THE INSTRUMENT WOULD NOT OPEN, NOR RESPOND. THE CUSTOMER COMPLETED THE PROCEDURE, AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24064150 ↗
• MalfunctionDec 31, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM STAPLER COULD NEITHER BE OPENED NOR CLOSED CORRECTLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935537 ↗
• MalfunctionDec 23, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, 45 SUREFORM STAPLER INSTRUMENT FAILED TO OPEN AFTER FIRE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23884383 ↗
• MalfunctionDec 23, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PROCEDURE, A SUREFORM 45 STAPLER INSTRUMENT FIRED A GREEN RELOAD AND BECAME STUCK ON LUNG TISSUE. THE SURGEON HAD NOT ENCOUNTERED ANY OBSTRUCTIONS BETWEEN THE INSTRUMENT'S JAWS. THERE WAS NO TISSUE TENSION OR TISSUE BUNCHING THAT OCCURRED. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY. THE SURGEON USED ANOTHER STAPLER INSTRUMENT TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876522 ↗
• InjuryDec 16, 2025Material Fragmentation; Material Fragmentation

  INTUITIVE SURGICAL RECEIVED A REPORT OF AN ISSUE WITH THE SUREFORM STAPLER 45 INSTRUMENT. THE ISSUE WAS NOT PROVIDED. THE RECORD WAS MARKED THAT A FRAGMENT HAD FALLEN INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THERE WAS AN X-RAY PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816627 ↗
• MalfunctionDec 12, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, SUREFORM 45 INSTRUMENT WOULD NOT RELEASE FROM TISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, DURING SECOND FIRING, AFTER INSPECTION AND CLEANING DID NOT FIND ANY DAMAGE OR ABNORMALITY. A LUNG LOBECTOMY WAS BEING PERFORMED WHEN THE ISSUE OCCURRED DURING A STAPLING OF A LUNG SECTION. NO ERRORS OCCURRED. THE JAWS WERE STUCK ON TISSUE HOWEVER THE SURGEON/OR STAFF WAS ABLE TO SUCCESSFULLY OPEN THE JAWS INTRAOPERATIVELY AND RELEASE THE TISSUE BY USING A MANUAL RELEASE ON THE STAPLER. NO ADVERSE EFFECT TO THE TISSUE. NO UNEXPECTED TISSUE REMOVAL. NO BLEEDING. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796574 ↗
• MalfunctionNov 17, 2025Difficult to Open or Close; Difficult to Open or Close

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23576521 ↗
• MalfunctionNov 10, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, CUSTOMER USED THE SUREFORM 45 STAPLER INSTRUMENT, AND IT WOULD NOT OPEN UP. THE SALES REPRESENTATIVE WAS CONTACTED, AND THE CUSTOMER TRIED AGAIN. THE INSTRUMENT WOULD NOT OPEN UP. A SECOND STAPLER WAS USED, AND IT WOULD NOT WORK. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPY WITH NO REPORTED INJURY. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE FOLLOWED UP AND OBTAINED ADDITIONAL INFORMATION. THE CUSTOMER INFORMED BOTH STAPLERS WERE USED ON THE SAME CASE/PATIENT AND WERE FOUND OUT OF THE BOX FAILURES. THE INSTRUMENT WAS INSPECTED WHEN IT WAS TAKEN RIGHT OUT OF THE BOX, AND NO DAMAGE WAS FOUND ON THE BOX OR INSTRUMENT. THE PROCEDURE WAS A ROBOTIC GASTROJEJUNOSTOMY. THE CUSTOMER WAS GOING TO USE THE STAPLER ON THE STOMACH WHEN THE ISSUE OCCURRED. THE CUSTOMER WAS NEVER ABLE TO GET THE INSTRUMENT TO WORK ON THE ROBOT. THE CUSTOMER CALLED THE INTUITIVE SURGICAL, INC. (ISI) SALES REPRESENTATIVE FOR ASSISTANCE OVER THE PHONE, BUT IT DID NOT HELP. THEY OPENED A SECOND STAPLER, AND IT STILL DID NOT WORK. THE JAWS OF THE STAPLER NEVER CAME IN CONTRACT WITH THE TISSUE OR THE PATIENT. THERE WAS NO BLEEDING. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513012 ↗
• MalfunctionNov 10, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTROJEJUNOSTOMY SURGICAL PROCEDURE, THE CUSTOMER USED A SUREFORM 45 STAPLER INSTRUMENT, AND IT WOULD NOT OPEN UP. A SECOND SUREFORM 45 STAPLER INSTRUMENT WAS USED, AND IT WOULD NOT WORK. THE CUSTOMER CONVERTED TO A TRADITIONAL LAPAROSCOPIC SURGERY. THERE WAS A PROCEDURE DELAY OF OVER THIRTY MINUTES. THERE WAS NO REPORTED INJURY TO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: THE INSTRUMENT WAS INSPECTED WHEN IT WAS TAKEN RIGHT OUT OF THE BOX, AND NO DAMAGE WAS FOUND ON THE BOX OR INSTRUMENT. THE PROCEDURE WAS A ROBOTIC GASTROJEJUNOSTOMY. THE CUSTOMER WAS GOING TO USE THE STAPLER ON THE STOMACH WHEN THE ISSUE OCCURRED. THE CUSTOMER WAS NEVER ABLE TO GET THE INSTRUMENT TO WORK ON THE ROBOT. THE CUSTOMER CALLED THE ISI SALES REPRESENTATIVE FOR ASSISTANCE OVER THE PHONE, BUT IT DID NOT HELP. THE CUSTOMER OPENED A SECOND STAPLER, AND IT STILL DID NOT WORK. THE JAWS OF THE STAPLER NEVER CAME IN CONTRACT WITH THE TISSUE OR THE PATIENT. THERE WAS NO BLEEDING. THE PROCEDURE WAS CONVERTED TO A TRADITIONAL LAPAROSCOPIC SURGERY. THE PATIENT TOLERATED THE CHANGE; IT JUST TOOK LONGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512797 ↗
• MalfunctionSep 16, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER WOULD NOT OPEN OR CLOSE IN THE ABDOMEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065219 ↗
• MalfunctionSep 5, 2025Break; Crack; Break; Crack

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 22985894 ↗
• MalfunctionSep 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER HAD A CRACK IN THE BLACK AREA OF THE STAPLER.

  Patient problems: Insufficient Information

  MAUDE report 22958969 ↗
• MalfunctionAug 11, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE WRIST OF THE SUREFORM 45 STAPLER INSTRUMENT WAS NOT EASY TO CONTROL. 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 22774272 ↗
• MalfunctionAug 8, 2025Difficult to Open or Close; Difficult to Open or Close

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749671 ↗
• MalfunctionJun 30, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER INSTRUMENT WOULD NOT OPEN. THE USER COMPLETED THE PROCEDURE AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367287 ↗