SureForm 48360WRecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00886874113820), received between Jan 4, 2021 and Sep 18, 2026 — classified as 18 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (11 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Material Fragmentation; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50827193 ↗
• MalfunctionJun 3, 2026Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 60 WHITE STAPLER RELOAD DID NOT COMPLETE THE FIRING SEQUENCE AND STOPPED MIDWAY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 25382902 ↗
• InjuryApr 22, 2026Material Separation; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SINGLE ANASTOMOSIS DUODENO-IILEAL BYPASS WITH SLEEVE GASTRECTOMY (SADI-S) SURGICAL PROCEDURE, THE OPERATING ROOM TEAM STATED, "THE STAPLES GOT STUCK UNDER THE GROOVE THAT FIRES/PUSHES THE BLADE. THE CUSTOMER ATTEMPTED WIPING AND IRRIGATING THEM OUT, BUT THEY WERE STUCK. THIS CAUSED STAPLES TO STICK TO THE INSTRUMENT AND BOWEL." THE INDIVIDUAL STAPLES THAT WERE SUPERFICIALLY STUCK TO THE BOWEL¿BUT NOT PART OF THE ANASTOMOSIS¿WERE RETRIEVED USING A GRASPER. ACCORDING TO THE PROVIDER, THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE STAPLER WAS INSPECTED PRIOR TO USE AND FOUND TO BE FREE OF DEFECTS. DURING THE FIRST FIRE, LOOSE STAPLES WERE OBSERVED IN THE TISSUE, ALTHOUGH THE STAPLER FIRED COMPLETELY WITHOUT INTERRUPTION AND DID NOT PUSH OR DRAG TISSUE. ALL LOOSE STAPLES WERE RETRIEVED USING AN ASSIST LAP GRASPER AND CONFIRMED BY VISUAL INSPECTION, WITH NO NEED FOR ADDITIONAL PROCEDURES OR POST-OPERATIVE IMAGING. NO ERROR MESSAGES WERE REPORTED DURING THE EVENT. MULTIPLE STAPLES WERE MISSING FROM THE STAPL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953025 ↗
• MalfunctionApr 9, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 60 WHITE RELOAD DID NOT COMPLETE THE FIRING SEQUENCE AND STOPPED MIDWAY THROUGH. THE USER COMPLETED THE PROCEDURE AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24836937 ↗
• MalfunctionApr 9, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 60 WHITE RELOAD DID NOT COMPLETE THE FIRING SEQUENCE AND STOPPED MIDWAY THROUGH. THE USER COMPLETED THE PROCEDURE AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24836931 ↗
• MalfunctionNov 14, 2025Difficult to Open or Close

  SURGEON WAS USING THE DAVINCI VESSEL SEALER DURING THE PROCEDURE. THE VESSEL SEALER CLAMPED DOWN ON TISSUE AND WHEN THE SURGEON TRIED TO RELEASE THE SEALER FROM THE TISSUE IT WOULD NOT UNCLAMP. THE SCRUB TECH WAS TOLD TO MANUALLY RELEASE THE CLAMP OF THE VESSEL SEALER OFF OF THE TISSUE. THE SURGEON OBSERVED THE TISSUE AS THE MANUAL RELEASE WAS PERFORMED. NO HARM WAS OBSERVED ON THE TISSUE BY THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554616 ↗
• MalfunctionSep 12, 2025No Device Output; No Device Output

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23043410 ↗
• MalfunctionSep 12, 2025Firing Problem; Firing Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23041966 ↗
• InjuryAug 7, 2025Failure to Form Staple; Failure to Form Staple

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22736792 ↗
• InjuryFeb 18, 2025Firing Problem; Firing Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21405224 ↗
• MalfunctionFeb 13, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER WAS BROKEN WITH THE CLIP ON. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381855 ↗
• MalfunctionFeb 12, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER INSTRUMENT STOPPED FIRING, AND FUNCTIONING, AND WOULD NOT UNLOAD DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21369837 ↗
• MalfunctionOct 11, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER INSTRUMENT STARTED TO FIRE, BUT THE TISSUE WAS TOO THICK. THE SURGEON TRIED TO RETRACT THE BLADE, AND IT LOCKED UP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20434677 ↗
• MalfunctionOct 8, 2024Failure to Fire; Firing Problem; Failure to Fire; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED A DEFECTIVE SUREFORM WHITE STAPLE RELOAD AS IT WAS JAMMED (3RD LOAD). THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20394342 ↗
• InjurySep 24, 2024Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER INSTRUMENT GOT STUCK ON STOMACH TISSUE AFTER FIRING A WHITE SUREFORM 60 RELOAD. AT LEAST THREE UNFORMED AND UNDEPLOYED STAPLES ON THE WHITE SUREFORM 60 RELOAD CAUSED TISSUE TO BE STUCK TO THE STAPLER RELOAD. THE SYSTEM DID NOT DISPLAY ANY ERRORS/MESSAGES DURING THE EVENT. IN ORDER TO SAFELY REMOVE THE STAPLER INSTRUMENT, THE TISSUE WAS TRANSECTED FROM THE STAPLER RELOAD. THIS CAUSED A LESS THAN 15 MINUTE DELAY IN THE CASE. THERE WERE NO HOLES/GAPS ON THE STAPLE LINE. THERE WERE NO OBSTRUCTIONS, EXISTING STAPLE LINES, OR BUTTRESS MATERIAL IN THE PATH OF THE STAPLER INSTRUMENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH THE SAME SUREFORM 60 STAPLER INSTRUMENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20295515 ↗
• InjurySep 13, 2024Failure to Fire; Failure to Fire

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 20211259 ↗
• MalfunctionAug 6, 2024Difficult to Remove; Failure to Fire; Difficult to Remove; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SADI-S SURGICAL PROCEDURE, AFTER STAPLING WITH A SUREFORM STAPLER 60 INSTRUMENT, AN ERROR MESSAGE POPPED UP ON THE SCREEN "POSSIBLE FAILURE DETECTED WHILE UNCLAMPING. USE GRIPS TO VERIFY JAWS ARE OPEN. DO NOT REUSE." THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19924866 ↗
• MalfunctionApr 10, 2024Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE WHITE 60 SUREFORM RELOAD DID NOT FIRE COMPLETELY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS A SLEEVE GASTRECTOMY. BELIEVES THE ISSUE OCCURRED ON THE SECOND FIRING ATTEMPT. THE TISSUE WAS NOT CALCIFIED, WAS NOT TOO THICK, HAD NO TENSION, AND THERE WAS NO BUNCHING. THE SUBSEQUENT LOAD WAS THE SAME COLOR AND COMPLETED THE FIRING SEQUENCE. THERE WERE STAPLES WITH A "U" SHAPE. THE ERROR MESSAGE RECEIVED WAS "UNABLE TO FIRE, TOO THICK, BLADE EXPOSED". THERE WAS NOTHING IN THE JAWS. SINCE THIS WAS THE SECOND FIRING, THE SURGEON WAS FIRING OVER AN EXISTING STAPLE LINE. THERE WAS NO BLEEDING. THERE IS A VIDEO AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077211 ↗
• InjuryMar 21, 2024Firing Problem; Firing Problem

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18954106 ↗
• MalfunctionMar 1, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS (ROUX-EN-Y) SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER INSTRUMENT WOULD NOT ARTICULATE PROPERLY. 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 SURGEON¿S HEAD WAS INSIDE THE SURGEON CONSOLE¿S HIGH RESOLUTION STEREO VIEWER WHEN THE ISSUE OCCURRED. THE ISSUE OCCURRED WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SURGEON CONSOLE. THE FAILURE IS RELATED TO AN INABILITY TO MOVE THE INSTRUMENT AT ALL (E.G., STATIC INSTRUMENT). THE MOVEMENTS OF THE SURGEON DID NOT SCALE APPROPRIATELY TO THE INSTRUMENT (E.G., DISTANCE INTENDED MATCHED DISTANCE INSTRUMENT MOVED. THE STAPLER DID NOT APPROPRIATELY ARTICULATE WHEN ATTEMPTING TO MOVE THE TIP OF THE STAPLER UP. THE INSTRUMENT DID NOT MOVE IN THE INTENDED DIRECTION. THE SURGEON ATTEMPTED TO MOVE THE STAPLE ANGLE UP AND IT DID NOT RESPOND. THE TIMING OF INSTRUMENT MOVEMENT WAS NOT APPROPRIATE. THERE WAS NOT ANY SHAKINESS AND/OR FRICTION EXPERIENCED/OBSERVED. THERE WAS NOT ANY INSTRUMENT-TO-INSTRUMENT OR SYSTEM ARM-TO-ARM INTERFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18822637 ↗
• InjuryFeb 2, 2024Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, THE STAPLE LINE LEAKED. IT WAS REPORTED THE SUREFORM 60 STAPLER INSTRUMENT FIRED WITH MULTIPLE WHITE RELOADS AND A BLUE RELOAD, WHEN A LEAK TEST WAS PERFORMED IT SHOWED MULTIPLE LEAKS WITHIN THE STAPLE LINE ON STOMACH TISSUE AND SMALL BOWEL. TO ADDRESS THE LEAK THE SURGEON IMBRICATED THE ENTIRE POUCH, STOMACH AND SMALL BOWEL WITH RUNNING SUTURE, ADDING AN ADDITIONAL HOUR AND THIRTY MINUTES TO THE PROCEDURE. THERE WERE NO REPORTED ERRORS WITH THE SUREFORM 60 STAPLER INSTRUMENT OR THE MULTIPLE RELOADS, NO TISSUE PUSH EVENTS, AND NO MALFORMED STAPLES WERE PRODUCED. THE SURGEON NOTED THE ENTIRE STAPLE LINE LOOKED COMPLETE, BUT DURING THE LEAK TEST IT WAS THEN NOTICED THE STAPLE LINE WAS LEAKING, NO SIGNIFICANT BLEEDING OCCURRED. NO ADDITIONAL TISSUE RESECTION WAS REQUIRED, NO BUTTRESS MATERIAL WAS USED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO FURTHER EVENTS. A DRAIN WAS PLACED INTRAOPERATIVELY DUE TO THE ADDITIONAL SUTURE AND WAS REMOVED WITH NO ISSUES ON POSTOPERATIVE DAY EIGHT. THE PATIENT STAYED AN ADDITIONAL DAY IN THE HOSPITAL, BUT THERE HAVE NOT BEEN ANY COMPLICATIONS POSTOPERATIVELY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18631664 ↗
• InjuryJan 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED SLEEVE GASTRECTOMY, THE PATIENT EXPERIENCED STAPLE LINE BLEEDING DESPITE NO INTRAOPERATIVE MALFUNCTIONS. INTRAOPERATIVELY, THE SURGEON USED SEAMGUARD ON ONE SIDE OF THE STAPLE LINE AND PERFORMED A LEAK TEST VIA ESOPHAGOGASTRODUODENOSCOPY (EGD). THE PATIENT¿S HOSPITALIZATION WAS EXTENDED TO MONITOR HEMOGLOBIN LEVELS. THERE WAS NO OTHER REPORTED MEDICAL INTERVENTION PROVIDED DUE TO THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18586087 ↗
• InjuryJan 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED SLEEVE GASTRECTOMY, THE PATIENT EXPERIENCED STAPLE LINE BLEEDING DESPITE NO INTRAOPERATIVE MALFUNCTIONS. INTRAOPERATIVELY, THE SURGEON USED SEAM GUARD ON ONE SIDE OF THE STAPLE LINE AND PERFORMED A LEAK TEST VIA ESOPHAGOGASTRODUODENOSCOPY (EGD). THE PATIENT¿S HOSPITALIZATION WAS EXTENDED TO MONITOR HEMOGLOBIN LEVELS. THERE WAS NO OTHER REPORTED MEDICAL INTERVENTION PROVIDED DUE TO THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18586083 ↗
• InjuryDec 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED PROCEDURE, BLEEDING OCCURRED FROM A STAPLE LINE CREATED WITH A SUREFORM 60 STAPLER INSTRUMENT LOADED WITH A WHITE SUREFORM 60 STAPLER RELOAD. FURTHER DETAILS REGARDING THE ISSUE THAT OCCURRED, THE AMOUNT OF UNEXPECTED BLEEDING, ANY MEDICAL INTERVENTIONS REQUIRED, AND ANY OTHER INFORMATION REGARDING THE EVENT ARE UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE FOR ADDITIONAL INFORMATION, AND THE CUSTOMER RESPONDED THAT THEY WERE UNABLE TO PROVIDE FURTHER DETAILS REGARDING THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18415337 ↗
• InjuryDec 11, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY, THE PATIENT EXPERIENCED A STAPLE LINE BLEED. THE SURGEON STATED THEIR TECHNIQUE FOR THE PROCEDURE HAS NOT CHANGED. THE SURGEON SAID THEY PERFORM AN INTRACORPOREAL ANASTOMOSIS USING THE SUREFORM 60 STAPLER INSTRUMENT. THEN, TWO SUREFORM 60 BLUE RELOADS ARE USED TO DIVIDE THE BOWEL. A SUREFORM 60 WHITE RELOAD IS USED FOR THE SIDE-TO-SIDE ANASTOMOSIS. AFTER THE COMPLETION OF THE FIRE, THE STAPLE LINE IS CONFIRMED TO BE IN GOOD CONDITION. THE SURGEON CHECKS THE ENTIRE ABDOMEN FOR ANY BLEEDING; THE PATIENT IS THEN CLOSED, AND THE PROCEDURE WAS COMPLETED. POST-OP DAY 1, THE PATIENT DEVELOPED A MAJOR BLEED; THE PATIENT'S HEMOGLOBIN HAD DROPPED FROM 15 G/DL TO 7G/DL AND WAS EXPERIENCING BLOODY STOOLS. THE SURGEON BELIEVED THIS WAS A RESULT OF A STAPLE LINE LEAK FROM THE SIDE-TO-SIDE ANASTOMOSIS. THE PATIENT WAS GIVEN A BLOOD TRANSFUSION, REQUIRING ADDITIONAL HOSPITALIZATION FOR OBSERVATION. THE PATIENT WAS LATER DISCHARGED HOME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18308023 ↗