Sureform 488530Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00886874121726), received between Jun 30, 2022 and Sep 28, 2026 — classified as 1 death, 6 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (14 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. Oct 7, 2022Open, Classified

   Potential staple deployment failure and device fragment generation

   Z-0340-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926105 ↗
• MalfunctionJun 5, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, AFTER INSERTING THE CARTRIDGE INTO THE SUREFORM 30 CURVED-TIP STAPLER, THE TIP WOULD NOT OPEN. THE PROCEDURE WAS COMPLETED AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25417247 ↗
• MalfunctionJun 3, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE FIRING WENT WELL WITH SUREFORM 30 CURVED TIP STAPLER INSTRUMENT UNTIL THE CLAMPING ACTION HAD TO BE RELEASED. THEN A MESSAGE APPEARED AND THE STAPLER BECAME DIFFICULT. AFTER RELEASING THE CLAMPING ACTION, THE STAPLER INDICATED IT COULD NO LONGER BE USED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. INTUITIVE SURGICAL (IS) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE STAPLER MADE AN ANNOUNCEMENT THAT IT COULD NO LONGER BE USED. THE CUSTOMER USED MORE THAN ONE BACK UP INSTRUMENT TO COMPLETE THE PROCEDURE. THE FIRST BACK-UP STAPLER GAVE THE SAME ERROR/MASSAGE. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25381016 ↗
• MalfunctionMay 27, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER USED 3 DIFFERENT RELOADS AND STILL COULD NOT GET THE JAWS TO CLOSE ON THE 8MM SUREFORM 30 STAPLER INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25296286 ↗
• MalfunctionApr 7, 2026Break; Material Fragmentation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24796635 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE BLADE BROKE OFF THE CURVED-TIP SUREFORM 30 STAPLER INSTRUMENT AFTER THE RELOAD WAS REMOVED. NO FRAGMENT FELL INTO THE PATIENT. 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 BROKEN PART OF THE BLADE WAS SENT BACK. ALSO, THERE WAS NO PHOTOS OR VIDEOS AVAILABLE PATIENT INFORMATION CANNOT BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24318068 ↗
• MalfunctionFeb 3, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 30 CURVED-TIP STAPLER INSTRUMENT WOULD NOT OPEN AND HAD TO BE MANUALLY OPENED. NO FRAGMENT FELL INTO THE PATIENT. THE CUSTOMER COMPLETED THE PROCEDURE WITH THE SAME INSTRUMENT AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251668 ↗
• MalfunctionJan 23, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM STAPLER INSTRUMENT WOULD NOT FIRE AND REPORTED THAT IT NEEDED A RELOAD. THE SUREFORM STAPLER INSTRUMENT WAS RELOADED MULTIPLE TIMES AND WOULD NOT OPEN TO FIRE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24165438 ↗
• DeathJan 16, 2026Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY RIGHT MIDDLE LOBECTOMY SURGICAL PROCEDURE, BLEEDING OCCURRED FOLLOWING STAPLING OF THE PULMONARY ARTERY (PA). THE SURGEON REPORTED THAT A SUREFORM 30 STAPLER INSTRUMENT WITH A GRAY RELOAD WAS POSITIONED CLEANLY AROUND THE PA AND WAS FIRED WITH NO ERROR MESSAGES DURING THE FIRING SEQUENCE. THE SURGEON REPORTED THAT, ¿AFTER THE FIRING WAS COMPLETE, BLEEDING AROUND THE RELOAD WAS IMMEDIATE. IT APPEARED THAT NO STAPLES WERE APPLIED TO THE PA. THE STAPLER WAS REMOVED AND MASSIVE BLEEDING OCCURRED.¿ ONE UNSPECIFIED INSTRUMENT WAS LEFT DOCKED AND USED TO APPLY PRESSURE TO CONTROL BLEEDING WHILE THE PROCEDURE WAS CONVERTED TO OPEN. HOWEVER, DESPITE OPENING AND RESUSCITATION EFFORTS, THE PATIENT EXPIRED IN THE OPERATING ROOM.

  Patient problems: Exsanguination; Failure to Anastomose; Great Vessel Perforation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24099648 ↗
• MalfunctionJan 12, 2026Difficult to Open or Close

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035848 ↗
• MalfunctionDec 15, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT AFTER FIRING THE FIRST LOAD AND REMOVING OFF THE ROBOT ARM, THE JAW REMAINED STUCK CLOSED. THE CUSTOMER THEN REPLACED WITH ANOTHER STAPLER, WHERE THE SAME THING HAPPENED AGAIN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION: THE CUSTOMER INFORMED THEY WOULD CANCEL THE RETURN OF THE INSTRUMENT.

  Patient problems: Insufficient Information

  MAUDE report 23809139 ↗
• MalfunctionDec 12, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT AFTER FIRING THE FIRST LOAD AND REMOVING THE SUREFORM STAPLER INSTRUMENT FROM THE ROBOT ARM, THE JAW REMAINED STUCK CLOSED. THE CUSTOMER REPLACED WITH ANOTHER SUREFORM STAPLER INSTRUMENT, WHERE THE SAME THING HAPPENED AGAIN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI OBTAINED THE FOLLOWING INFORMATION: THE CUSTOMER INFORMED THEY WOULD CANCEL THE RETURN OF THE INSTRUMENT.

  Patient problems: Insufficient Information

  MAUDE report 23796754 ↗
• MalfunctionDec 11, 2025Failure to Form Staple; Failure to Fire

  WHEN TRYING TO FIRE THE STAPLER WITH THE DV5 SYSTEM, REPEATED ERRORS STATING THAT NO STAPES LOADED OR STAPLES PREVIOUSLY USED WERE GIVEN BY THE SYSTEM. THE STAPLER AND ALL ERROR LOADS WERE SAVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782981 ↗
• MalfunctionOct 31, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 30 STAPLER INSTRUMENT MALFUNCTIONED AND UNABLE TO RECOGNIZE LOAD ONCE IN PATIENT, DID NOT ROTATE PROPERLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23442650 ↗
• InjuryOct 23, 2025Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23372834 ↗
• MalfunctionOct 22, 2025Firing Problem; Firing Problem

  ON 29-SEP-2025, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY MEDWATCH REPORT (MDR) WITH MDR REPORT #MW5175135 STATING: "STAPLER MISFIRED. ERROR MESSAGE STATED, "TOO MUCH TISSUE IN THE STAPLER JAW". STAPLE FOUND LYING ACROSS THE STAPLE FIRING LINE ON THE JAW."

  Patient problems: Insufficient Information

  MAUDE report 23363311 ↗
• MalfunctionSep 16, 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 23066935 ↗
• MalfunctionSep 10, 2025Difficult to Remove; Difficult to Remove

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018840 ↗
• MalfunctionAug 29, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE, THE SUREFORM STAPLER JAWS WERE SLOW TO OPEN, NEEDED TO BE FORCED OPEN, SURGEON STATED THAT IT FELT LIKE THE POWER WAS NOT ON. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922691 ↗
• MalfunctionAug 25, 2025Device Dislodged or Dislocated; Firing Problem; Device Dislodged or Dislocated; Firing Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891256 ↗
• MalfunctionJul 10, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE SUREFORM 30 CURVED TIP STAPLER WAS UNABLE TO OPEN. THE CUSTOMER TRIED TO USE THE INSTRUMENT MULTIPLE TIMES BUT IT DID NOT WORK. THE USER COMPLETED THE PROCEDURE USING A BACKUP INSTRUMENT WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE STAPLER FUNCTIONED CORRECTLY AND WAS REMOVED FROM THE PATIENT. THE STAFF WAS UNABLE TO OPEN THE INSTRUMENT TO PUT IN ANOTHER RELOAD SO A BACKUP STAPLER WAS USED TO CONTINUE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470381 ↗
• MalfunctionJun 24, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, CUSTOMER REPORTED THE STAPLER WOULD NOT OPEN DURING CASE, WOULD NOT FIRE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE JAWS WERE NOT STUCK ON TISSUE WHEN THE ISSUE OCCURRED. NO UNEXPECTED TISSUE REMOVAL. NO BLEEDING OBSERVED. THE INSTRUMENT WAS SENT IN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22312916 ↗
• MalfunctionJun 7, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, WHEN ATTEMPTING PULMONARY ATTEMPTING BRANCHING PROCESS, A TISSUE TOO THICK TO CONTINUE (TTTTC) MESSAGE DISPLAYED AND THE FIRE COULD NOT BE COMPLETED. NO FRAGMENT FELL INTO THE PATIENT. THE USER COMPLETED THE PROCEDURE AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: A WHITE RELOAD WAS INVOLVED WITH THE REPORTED EVENT. THE SURGEON SELECTED THIS PARTICULAR RELOAD DUE TO DISSECTING A BRANCH OF THE PULMONARY ARTERY. THE 3RD STAPLER WAS INVOLVED WITH THE REPORTED EVENT. A DISSECTION OF THE PULMONARY ARTERY BRANCH WAS BEING PERFORMED AT THE TIME OF THE EVENT. THE TARGET TISSUE WAS A VESSEL. THE TISSUE WAS NOT CALCIFIED. THE TISSUE WAS NOT EXPOSED TO ANY RADIATION OR CHEMOTHERAPY PRIOR TO THE PROCEDURE. THERE WAS NO TISSUE TENSION. THERE WAS NO TISSUE BUNCHING. THE ISSUE INVOLVED A PARTIAL FIRE. THERE WERE NO MALFORMED OR UNFORMED STAPLES. THE RELOAD DID NOT HAVE AN EXPOSED BLADE. THERE WERE NO STAPLES MISSING FROM THE STAPLE LINE. THERE WERE NO HOLES/GAPS OBSERVED WITHIN THE STAPLE LINE. THE REL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22163248 ↗
• MalfunctionApr 16, 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 21847020 ↗
• MalfunctionMar 28, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE 8MM SUREFORM 30 STAPLER INSTRUMENT HAD A CLEAR FILM-LIKE SUBSTANCE LODGED IN THE JOINT AT THE WRIST AREA, WHICH COULD NOT BE REMOVED. THE DOCTOR NOTICED IT JUST BEFORE THE FIRST STAPLER FIRE, AND IN THE CUSTOMERS OPINION THE SUBSTANCE WAS ALREADY ADHERED TO THE STAPLER AT THE MANUFACTURING STAGE. (IMAGE IS ATTACHED) THE SURGEON CONTINUED TO USE THE STAPLER BECAUSE HE DID NOT HAVE ANY PROBLEMS WHEN USING IT. HOWEVER, SINCE THERE WERE NO PROBLEMS WITH USING IT, THEY DECIDED TO CONTINUE USING IT. 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 STAFF CHECKED THE INSTRUMENT VISUALLY BEFORE USE, BUT THE FOREIGN MATTER WAS SO SMALL THAT HE DIDN'T NOTICE IT. THE FOREIGN MATTER WAS NOTICED JUST BEFORE THE FIRST STAPLING BUT NOT WHEN OPENING THE PACKAGE. THE INCIDENT DID NOT INVOLVE A FRAGMENT FALLING INSIDE PATIENT ANATOMY. THE INSTRUMENT IS AVAILABLE FOR RETURN TO ISI FOR ANALYSIS. THE FOREIGN MATTER WAS STILL ATTACHED TO THE TIP AND WAS RETURNED TOGETHER WITH THE INSTRUME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724796 ↗