Sureform 48230WRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00886874121924), received between Jun 17, 2022 and Sep 30, 2026 — classified as 4 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break; Unintended Movement

  Patient problems: Insufficient Information

  MAUDE report 50953177 ↗
• MalfunctionSep 28, 2026Ejection Problem

  Patient problems: Insufficient Information

  MAUDE report 50925589 ↗
• MalfunctionAug 5, 2026Firing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50144207 ↗
• MalfunctionJun 29, 2026Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A SUREFORM 30 STAPLER INSTRUMENT FIRED A WHITE RELOAD WHICH DID NOT FIRE AS EXPECTED AND RESULTED IN STAPLES MISSING FROM THE STAPLE LINE. A NURSE WHO WAS PRESENT DURING THIS EVENT REPORTED THAT DIFFICULTIES WERE EXPERIENCED WHILE LOADING THE WHITE RELOAD INTO THE STAPLER INSTRUMENT AND PRIOR TO BEING INSERTED INTO THE PATIENT. ALTHOUGH IT WAS REPORTED THAT STAPLES WERE MISSING FROM THE STAPLE LINE, IT WAS SPECIFIED THAT THERE WAS NO BLEEDING DUE TO THIS EVENT. THE SURGEON USED A BACK-UP INSTRUMENT TO CONTINUE THE PROCEDURE. WHEN ASKED IF THE SURGEON CONTINUED THE SAME STAPLE LINE, STAPLED NEXT TO THIS WHITE RELOAD STAPLE LINE, OR TOOK ADDITIONAL TISSUE, THE NURSE ANSWERED, "NOT APPLICABLE.". NO IMAGES OR VIDEOS WERE TAKEN OF THIS EVENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659796 ↗
• MalfunctionJun 25, 2026No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE STAPLER 30 WHITE RELOAD WOULD NOT LOAD THEN FAILED TO FIRE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25630207 ↗
• MalfunctionMar 21, 2026No Device Output

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24657029 ↗
• MalfunctionMar 14, 2026Break

  IT WAS REPORTED THAT ONE NEEDLE HAD COME OFF THE STAPLER 30 WHITE RELOAD BEFORE IT WAS INSTALLED IN THE SUREFORM STAPLER INSTRUMENT. FURTHERMORE, SEVERAL NEEDLES FELL OFF WHEN INSTALLING THE OTHER STAPLER 30 WHITE RELOAD. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24600382 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT ONE NEEDLE HAD COME OFF THE STAPLER 30 WHITE RELOAD BEFORE IT WAS INSTALLED IN THE SUREFORM STAPLER INSTRUMENT. FURTHERMORE, SEVERAL NEEDLES FELL OFF WHEN INSTALLING THE OTHER STAPLER 30 WHITE RELOAD. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE EVENT OCCURRED WHEN UNPACKED BEFORE PLACING THE RELOAD INTO THE JAW. PATIENT WAS NOT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571898 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491338 ↗
• MalfunctionFeb 23, 2026Failure to Calibrate

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE STAPLER WOULD NOT INITIATE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24423891 ↗
• MalfunctionFeb 7, 2026Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24285514 ↗
• MalfunctionJan 9, 2026Break; Unintended Ejection; Material Fragmentation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24029732 ↗
• MalfunctionDec 24, 2025Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889753 ↗
• MalfunctionOct 28, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE SUREFORM STAPLER INSTRUMENT PRESENTED AN ERROR INDICATING THAT IT HAD A "MISSING OR USED RELOAD". CUSTOMER TRIED USING NEW RELOADS AND ULTIMATELY SWITCHED TO A DIFFERENT INSTRUMENT WHICH WORKED WITH NO ISSUES. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408215 ↗
• MalfunctionSep 9, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER WEDGE RESECTION SURGICAL PROCEDURE; THE WHITE STAPLER 30 RELOAD ACCESSORY HAD A RECOGNITION FAILURE. NO FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23008596 ↗
• MalfunctionSep 2, 2025Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22948721 ↗
• MalfunctionJul 31, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 30 CURVED TIP STAPLER DID NOT FIRE. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. THE INSTRUMENT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22681800 ↗
• MalfunctionJul 24, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS A BROKEN METAL PART OF THE STAPLER 30 WHITE RELOAD USE OF THE INSTRUMENT WAS DISCONTINUED, AND IT WAS REPLACED TO THE BACKUP. 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: IT WAS CONFIRMED THAT NO FRAGMENT FELL INTO THE PATIENT. THERE WAS AN ISSUE AFTER FIRING. THE CUSTOMER REMOVED THE INSTRUMENT AFTER FIRING. THE CUSTOMER REMOVED THE RELOAD USING A REMOVAL TOOL AND FOUND THAT THE INSTRUMENT JAWS WERE DIFFICULT TO OPEN AND CLOSE. THE CUSTOMER VISUALLY CHECKED THE JAWS AND FOUND A METAL PIECE AT THE BASE. AS IT COULD NOT BE REMOVED WITH TWEEZERS, THE CUSTOMER ATTEMPTED TO REMOVE THE INSTRUMENT BY HITTING IT AGAINST THE STERILIZATION TABLE. THE METAL PIECES SHOWN IN THE PROVIDED IMAGE FELL OUT FROM THE BASE OF THE JAWS. THE CUSTOMER CONTINUED THE SAME PROCEDURE USING NEW INSTRUMENTS. THERE ARE NO PHOTOS AND/OR VIDEOS OF THIS EVENT AVAILABLE FOR ISI REVIEW. PATIENT DEMOGRAPHICS WERE REQUESTED BUT WERE UNABLE TO B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22593314 ↗
• MalfunctionJul 23, 2025No Device Output; No Device Output

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 22582874 ↗
• InjuryJul 9, 2025Failure to Form Staple; Failure to Form Staple

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22460135 ↗
• MalfunctionJul 3, 2025No Device Output; No Device Output

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 22399492 ↗
• MalfunctionJun 7, 2025Positioning Problem; Positioning Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22162612 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED APPENDECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE TIP OF STAPLER 30 WHITE RELOAD BROKE OFF WHEN INSERTING INTO STAPLER. 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 LOAD WAS DAMAGED PRIOR TO STAPLER BEING INSERTED. NO FRAGMENTS WERE LOST OR RETAINED IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916452 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED APPENDECTOMY SURGICAL PROCEDURE, THE SUREFORM 30 STAPLER RELOAD TIP BROKE OFF WHEN INSERTING INTO STAPLER. 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 RELOAD WAS NEVER USED IN THE PATIENT. HENCE, NO FRAGMENTS WERE LOST OR RETAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21887658 ↗
• MalfunctionApr 17, 2025Positioning Problem; Firing Problem; Positioning Problem; Firing Problem

  IT WAS REPORTED THAT PRIOR TO THE START (PRE-ANESTHESIA) OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE WHITE STAPLER 30 RELOAD DID NOT CLOSE DURING SETUP. A BACKUP WAS USED TO COMPLETE THE PROCEDURE. NO FRAGMENTS FELL INTO THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO DELAYS. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT THE RELOAD WAS NOT INSERTED, THUS, NO FRAGMENTS FELL INTO THE PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO THE RETENTION OF FOREIGN MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856828 ↗