Sureform 48230BRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00886874121917), received between Jul 1, 2022 and Mar 23, 2026 — classified as 5 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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. Oct 7, 2022Open, Classified

   Potential staple deployment failure and device fragment generation

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

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE STAPLER 30 BLUE RELOAD COULD NOT BE INSTALLED ONTO THE STAPLER AS A STAPLE WAS PROTRUDING OUT OF THE RELOAD. THE RELOAD WAS NOT USED. THE USER COMPLETED THE PROCEDURE AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL (IS) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE RELOAD HAD ALREADY BEEN RETURNED. PHOTOS OF THE DEVICE OR A VIDEO OF THE PROCEDURE ARE NOT AVAILABLE FOR REVIEW BY INTUITIVE SURGICAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24666669 ↗
• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOWRIST 30 BLUE RELOAD SNAPPED IN HALF WHEN ENGAGING ON THE ANVIL. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. THE INSTRUMENT WAS NOT USED ON THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE RELOAD WAS COMPLETELY BROKEN INTO TWO PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24554773 ↗
• InjuryDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED APPENDECTOMY PROCEDURE, LOOSE STAPLES FROM TWO SUREFORM 30 RELOADS FELL INSIDE THE PATIENT. THE STAPLES WERE CLEANED UP, AND NO PATIENT INJURY WAS REPORTED. THE CUSTOMER OPENED A THIRD STAPLER RELOAD AND IT WAS NORMAL WITH NO LOOSE STAPLES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SUREFORM 30 RELOAD WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. ACCORDING TO THE CUSTOMER, THE SUREFORM 30 STAPLER INSTRUMENT DID NOT FIRE AT ALL. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE STAPLER RELOAD. ALL OF THE LOOSE STAPLES WERE RETRIEVED AND CONFIRMED VISUALLY. THERE WAS NO BLEEDING OBSERVED ALONG THE STAPLE LINE AND THERE WERE NO HOLES OR GAPS WITHIN THE STAPLE LINE. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INJURY TO THE PATIENT. NO ADDITIONAL SURGICAL PROCEDURES WERE REQUIRED TO REMOVE THE LOOSE STAPLES. FURTHERMORE, NO POSTOPERATIVE TESTS, SUCH AS ULTRASOUND, WERE PERFORMED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL FOR ANY POST-SURGICAL COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709198 ↗
• InjuryDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED APPENDECTOMY PROCEDURE, LOOSE STAPLES FROM TWO SUREFORM 30 RELOADS FELL INSIDE THE PATIENT. THE STAPLES WERE CLEANED UP, AND NO PATIENT INJURY WAS REPORTED. THE CUSTOMER OPENED A THIRD STAPLER RELOAD AND IT WAS NORMAL WITH NO LOOSE STAPLES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SUREFORM 30 RELOAD WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. ACCORDING TO THE CUSTOMER, THE SUREFORM 30 STAPLER INSTRUMENT DID NOT FIRE AT ALL. SURGEON DID NOT NOTICE ANY ISSUES WITH FUNCTIONALITY OF STAPLER RELOAD. ALL OF LOOSE STAPLES WERE RETRIEVED AND CONFIRMED VISUALLY. THERE WAS NO BLEEDING OBSERVED ALONG STAPLE LINE AND THERE WERE NO HOLES OR GAPS WITHIN STAPLE LINE. PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INJURY TO PATIENT. NO ADDITIONAL SURGICAL PROCEDURES WERE REQUIRED TO REMOVE THE LOOSE STAPLES. FURTHERMORE, NO POSTOPERATIVE TESTS, SUCH AS ULTRASOUND, WERE PERFORMED. PATIENT HAS NOT RETURNED TO HOSPITAL FOR ANY POST-SURGICAL COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708810 ↗
• MalfunctionAug 6, 2025Unintended Ejection; Firing Problem; Unintended Ejection; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE SUREFORM 30 STAPLER BLUE RELOAD DISENGAGED FROM THE INSTALLATION TOOL PRIOR TO INSTALLING THE RELOAD ONTO THE RELOAD CHANNEL. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731634 ↗
• MalfunctionAug 6, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, CUSTOMER REPORTED THAT WHEN THE STAPLER LOAD WAS FIRST LOADED ON THE 30 MM STAPLER IT WAS FOUND TO HAVE STAPLES THAT APPEARED TO BE PROTRUDING (DISLODGED) FROM THE LOAD. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS NOT USED ON THE PATIENT THEREFORE THE QUESTIONS DO NOT APPLY SINCE IT WAS PUT TO THE SIDE WHEN THEY SAW THE STAPLES PROTRUDING THROUGH THE LOAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22729468 ↗
• MalfunctionJul 29, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED APPENDECTOMY SURGICAL PROCEDURE, THE STAPLER 30 BLUE RELOAD ACCESSORY DID NOT LOAD CORRECTLY ONTO A STAPLER. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22651966 ↗
• MalfunctionJul 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE STAPLER RELOAD POINT BROKE OFF. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER CONFIRMED THAT THE DAMAGED PART OF THE STAPLER RELOAD WAS THE SMALL TIP. THE ACCESSORY WAS INSPECTED PRIOR TO USE. THERE WERE NO COLLISION DURING PROCEDURE. MATERIAL DETACHED/BROKE OFF FROM THE ACCESSORY. NO FRAGMENT FELL INSIDE THE PATIENT. THE RELOAD WAS ALREADY RETURNED FOR EVALUATION. NO IMAGES WERE AVAILABLE FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22465884 ↗
• MalfunctionJul 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22433152 ↗
• MalfunctionJul 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, POINT OF RELOAD BROKE OFF. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER CONFIRMED THAT THE DAMAGED PART OF THE STAPLER RELOAD WAS THE SMALL TIP. THE ACCESSORY WAS INSPECTED PRIOR TO USE. THERE WERE NO COLLISION DURING PROCEDURE. MATERIAL DETACHED/BROKE OFF FROM THE ACCESSORY. NO FRAGMENT FELL INSIDE THE PATIENT. THE RELOAD WAS ALREADY RETURNED FOR EVALUATION. NO IMAGES WERE AVAILABLE FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22433119 ↗
• MalfunctionJun 27, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOWRIST 30 BLUE STAPLER RELOAD WAS INSTALLED ONTO THE INSTRUMENT AND THE SURGEON DECIDED TO USE ANOTHER STAPLER. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL INC., (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO ISSUE WITH THE RELOAD, THE SURGEON DECIDED TO NOT USE THE RELOAD. THE SURGEON DECIDED TO SWITCH THE INSTRUMENTS TO USE VASCULAR STAPLER BEFORE THE BRONCHIAL STAPLER. PATIENT INFORMATION WAS REQUESTED BUT, CUSTOMER WAS UNABLE TO PROVIDE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344322 ↗
• MalfunctionApr 22, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED APPENDECTOMY SURGICAL PROCEDURE, WHILE LOADING THE STAPLER 30 BLUE RELOAD, THE SCRUB TECH NOTICED THAT A FEW STAPLES WERE EXPOSED. ANOTHER RELOAD WAS OPENED, LOADED, AND FIRED. AFTER THE PROCEDURE, THE RELOAD WAS EXAMINED AND NO STAPLES WERE NOTED TO BE EXPOSED. 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 21881718 ↗
• MalfunctionMar 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21557313 ↗
• MalfunctionFeb 18, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, STAPLES WERE STICKING OUT OF THE STAPLER 30 BLUE RELOAD. THE RELOAD WAS LOADED INTO THE STAPLER AND WHEN THE SECOND COVER WAS REMOVED, THE CUSTOMER NOTICED STAPLES STICKING UP OUT OF THE RELOAD. THE USER COMPLETED THE PROCEDURE AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE FOLLOWED UP AND OBTAINED ADDITIONAL INFORMATION. THE PROCEDURE WAS AN APPENDECTOMY, AND A BLUE RELOAD WAS USED FOR THE TYPE OF TISSUE. THE ISSUE OCCURRED ON THE 1ST FIRE, BUT IT WAS NEVER FIRED. THE RELOADS WERE STICKING OUT AND THE CUSTOMER WAS INSTRUCTED TO RETURN THE STAPLE RELOADS IF THEY FOUND THE STAPLES STICKING OUT. THE TARGETED TISSUE WAS THE APPENDIX. THE TISSUE WAS NOT CALCIFIED. THE TISSUE WAS NOT EXPOSED TO ANY RADIATION OR CHEMOTHERAPY PRIOR TO THE PROCEDURE. THERE WAS NOT ANY TISSUE TENSION. THERE WAS NOT ANY TISSUE BUNCHING. THE ISSUE DID NOT INVOLVE A FAILURE TO FIRE. THE EVENT DID NOT INVOLVE 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. THE EVENT DID NOT INVOLVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403428 ↗
• MalfunctionFeb 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, IT WAS INITIALLY REPORTED THAT AFTER FIRING A SUREFORM 30 CURVED-TIP STAPLER INSTRUMENT, A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE ISSUE OCCURRED WHILE FIRING THE STAPLER INSTRUMENT WITH A WHITE SUREFORM 30 RELOAD ACCESSORY AND AN ERROR WAS STATING, "TISSUE TOO THICK TOO CONTINUE" WAS OBSERVED. A BLUE SUREFORM 30 RELOAD WAS OBTAINED, AND UPON COMPLETION OF THE FIRING AND UNCLAMPING OF THE STAPLER, A FRAGMENT IDENTIFIED AS THE "BLADE" OF THE STAPLER INSTRUMENT, WAS NOTED TO HAVE FALLEN INTO THE PATIENT. THE SURGEON LATER CONFIRMED THAT THE FRAGMENT WAS ACTUALLY THE WEDGE LEG FROM THE STAPLER INSTRUMENT. THE WEDGE LEG WAS OBSERVED TO HAVE BENT DURING THE FIRING OF THE BLUE SUREFORM 30 RELOAD AND BROKE OFF WHEN THE STAPLER INSTRUMENT WAS UNCLAMPED. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY AND THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS. THE SURGEON WAS UNABLE TO CONFIRM WHETHER THE RELOAD INSTALLATION TOOL WAS UTILIZED FOR EITHER THE WHITE OR BLUE SUREFORM 30 RELOAD INSTALLATIONS. NO ABNORMALITIES WE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326836 ↗
• MalfunctionJan 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED APPENDECTOMY SURGICAL PROCEDURE, THE CUSTOMER NOTED THAT THE SUREFORM 30 BLUE RELOAD HAD STAPLES COMING OUT WHEN INSERTED INTO THE FIELD. THE CUSTOMER ADVISED THAT THE RELOAD WAS NEW AND THEY WERE CONFIDENT THEY WEREN'T UTILIZING ONE THAT HAD BEEN USED ALREADY. AS A RESULT, THE CUSTOMER OPENED A NEW RELOAD TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE RELOAD WAS NOT FIRED PRIOR TO THE IDENTIFIED ISSUE AND THE EVENT DID NOT RESULT IN LOOSE STAPLES FALLING INTO THE PATIENT ANATOMY. THE INCIDENT DID NOT RESULT IN MALFORMED OR UNFORMED STAPLES, THE RELOAD HAVING AN EXPOSED BLADE, STAPLES MISSING FROM THE STAPLE LINE, HOLES/GAPS OBSERVED WITHIN THE STAPLE LINE, OR THE RELOAD BEING STUCK TO TISSUE. THERE WAS NO BLEEDING OBSERVED ON THE STAPLE LINE DUE TO THE ISSUE. ADDITIONALLY, THERE WERE NO ERRORS/MESSAGES GENERATED AS THE DEFECT WAS NOTED AS SOON AS THE RELOAD WAS INSERTED. THE PART NUMBER AND LOT NUMBER FOR THE STAPLER INSTRUMENT WAS NOT NOTED AND THE SAME STAPLER INSTRUMENT WAS UTILIZED F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21069252 ↗
• InjuryJun 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 19533503 ↗
• InjuryJun 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 19518277 ↗
• InjuryJul 1, 2022Misfire; Misfire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LEFT UPPER TRI-SEGMENTECTOMY PROCEDURE, AN 8MM CURVED-TIP SUREFORM 30 STAPLER INSTRUMENT WAS USED TO FIRE A BLUE RELOAD ON PARENCHYMA. THE STAPLE LINE REPORTEDLY OOZED BLOOD AND AS A RESULT, THE SURGEON APPLIED ENERGY VIA A LONG BIPOLAR GRASPER INSTRUMENT TO CAUTERIZE AND STOP THE BLEEDING. THE SURGEON PERFORMED AN AIR LEAK AT THE END OF THE CASE AND NO LEAKS WERE OBSERVED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE SURGEON SAID THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14888313 ↗