SureForm 48345GRecalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00886874117095), received between Jan 12, 2022 and Sep 24, 2026 — classified as 34 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (23 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891155 ↗
• MalfunctionSep 3, 2026Firing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50595219 ↗
• MalfunctionJun 4, 2026Device Dislodged or Dislocated

  DURING THE INVESTIGATION OF AN EXISTING COMPLAINT, HE FAILURE ANALYSIS INVESTIGATION IDENTIFIED A POTENTIAL FRAGMENT SUCH AS A LODGED STAPLE FROM THE SUREFORM 45 CURVED-TIP STAPLER RELOAD.

  Patient problems: Insufficient Information

  MAUDE report 25401398 ↗
• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE RUBBER PIECE AT THE END OF THE STAPLER TORE AND BROKE MAKING THE INSTRUMENT INCAPABLE OF BEING USED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER WAS TOLD THAT IT MALFUNCTIONED IN A SURGERY. THE ONLY DETAILS THAT THE CUSTOMER WAS GIVEN WAS THAT THE INSTRUMENT WAS NOT WORKING PROPERLY.

  Patient problems: Insufficient Information

  MAUDE report 25238093 ↗
• MalfunctionMar 2, 2026Unintended Ejection

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE SUREFORM 45 GREEN RELOAD HAD A STAPLE HANGING OUT UPON ENTRY. 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: THE CUSTOMER WAS UNSURE IF A STAPLE COMPLETELY DETACHED FROM THE RELOAD AND WAS NOT SURE IF THE INSTRUMENT COLLIDED WITH ANOTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. NO FRAGMENT FELL INTO THE PATIENT AND THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490944 ↗
• InjuryJan 12, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE SUREFORM 45 GREEN RELOAD GOT OUT OF THE STAPLER WHILE STAPLING. 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 24032860 ↗
• MalfunctionDec 17, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE, A GREEN SUREFORM RELOAD STAPLING DEVICE WAS INSERTED FOR STAPLING A BRONCHUS. THE ROBOT INDICATED "STAPLE ALREADY USED." THE STAPLING DEVICE WAS REPOSITIONED, AND IT FUNCTIONED SOMEWHAT JERKILY BEFORE THE ROBOT FLAGGED THE TISSUE AS TOO THICK. THE STAPLING DEVICE APPEARED TO HAVE STAPLED AND CUT THE TISSUE BUT WOULD NOT OPEN. UPON OPENING, THE STAPLING DEVICE WAS FOUND TO BE COMPLETELY BENT AT THE END, WITH STAPLES THAT HAD NOT BEEN DEPLOYED AND THE BLADE APPEARING TO BE STUCK IN THE PLASTIC PART OF THE STAPLING DEVICE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825166 ↗
• InjuryDec 15, 2025Difficult to Remove; Failure to Form Staple; Difficult to Remove; Failure to Form Staple

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23803959 ↗
• InjuryDec 9, 2025Failure to Form Staple; Firing Problem; Failure to Form Staple; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE, THE SUREFORM 45 STAPLER INSTRUMENT EQUIPPED WITH A SUREFORM 45 GREEN RELOAD PRODUCED AN INCOMPLETE STAPLE LINE. THE INITIAL TWO FIRINGS, UTILIZING SUREFORM 45 WHITE RELOADS, WERE COMPLETED SUCCESSFULLY. THE THIRD FIRING, WITH THE FIRST SUREFORM 45 GREEN RELOAD, ALSO DEPLOYED WITHOUT ISSUE. HOWEVER, DURING THE FOURTH FIRING WITH THE SECOND SUREFORM 45 GREEN RELOAD, THE STAPLER INSTRUMENT GOT STUCK ON TISSUE, RESULTING IN AN INCOMPLETE STAPLE LINE AND FAILURE TO ACHIEVE COMPLETE CLOSURE OF THE STAPLE LINE. THE AFFECTED STAPLE LINE EXHIBITED TORN TISSUE AND INCOMPLETE STAPLE FORMATION. THE SURGEON SWITCHED TO A SECOND SUREFORM 45 STAPLER INSTRUMENT AND FIRED ANOTHER SUREFORM 45 GREEN RELOAD; HOWEVER, THE SAME ISSUE PERSISTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23760357 ↗
• InjuryDec 9, 2025Failure to Form Staple; Firing Problem; Failure to Form Staple; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE, THE SUREFORM 45 STAPLER INSTRUMENT EQUIPPED WITH A SUREFORM 45 GREEN RELOAD PRODUCED AN INCOMPLETE STAPLE LINE. THE INITIAL TWO FIRINGS, UTILIZING SUREFORM 45 WHITE RELOADS, WERE COMPLETED SUCCESSFULLY. THE THIRD FIRING, WITH THE FIRST SUREFORM 45 GREEN RELOAD, ALSO DEPLOYED WITHOUT ISSUE. HOWEVER, DURING THE FOURTH FIRING WITH THE SECOND SUREFORM 45 GREEN RELOAD, THE STAPLER INSTRUMENT GOT STUCK ON TISSUE, RESULTING IN AN INCOMPLETE STAPLE LINE AND FAILURE TO ACHIEVE COMPLETE CLOSURE OF THE STAPLE LINE. THE AFFECTED STAPLE LINE EXHIBITED TORN TISSUE AND INCOMPLETE STAPLE FORMATION. THE SURGEON SWITCHED TO A SECOND SUREFORM 45 STAPLER INSTRUMENT AND FIRED ANOTHER SUREFORM 45 GREEN RELOAD; HOWEVER, THE SAME ISSUE PERSISTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23760315 ↗
• InjuryDec 2, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, A SUREFORM 45 STAPLER INSTRUMENT FIRED A SUREFORM 45 GREEN RELOAD WHICH RESULTED IN AN INCOMPLETE STAPLE LINE ON PARENCHYMA. THE STAPLES WERE DEPLOYED AND TISSUE WAS CUT, BUT IT WAS REPORTED THAT THERE WERE THREE LINES OF STAPLES THAT WERE NOT PROPERLY PLACED INTO THE TISSUE. THERE WAS MINOR BLEEDING OF THE PARENCHYMA DUE TO THIS EVENT WHICH WAS CONTROLLED WITH ENERGY FROM A MARYLAND BIPOLAR FORCEPS INSTRUMENT. THE SURGICAL OUTCOME WAS NOT AFFECTED BY THIS EVENT AND THE PATIENT OUTCOME WAS REPORTED TO BE NORMAL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23701032 ↗
• InjuryNov 5, 2025Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROCEDURE, IMPROPER STAPLE POSITIONING WAS OBSERVED FOLLOWING A PARTIAL FIRE INCIDENT WITH A SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT, INSTALLED WITH A GREEN SUREFORM 45 RELOAD. AN ERROR MESSAGE, "TISSUE TOO THICK TO CONTINUE," WAS DISPLAYED AT THE TIME OF THE PARTIAL FIRE. UPON UNCLAMPING THE JAWS OF THE STAPLER INSTRUMENT, THE STAPLES WERE FOUND TO BE POORLY PLACED WITHIN THE TISSUE. AFTER REMOVAL OF THE STAPLER INSTRUMENT, THE GREEN SUREFORM 45 RELOAD REMAINED LODGED IN THE JAWS AND COULD NOT BE REMOVED. TO RESOLVE THE SITUATION, A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS UTILIZED TO COMPLETE THE SECTION. ADDITIONALLY, THE BRONCHIAL STUMP WAS MANUALLY SUTURED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23477375 ↗
• MalfunctionOct 16, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL GASTRECTOMY SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER RELOAD HAD EXPOSED BLADE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311955 ↗
• MalfunctionSep 16, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM STAPLER 45 INSTRUMENT HAD POOR MOVEMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SUREFORM STAPLER 45 INSTRUMENT WAS NOT RECOGNIZED WHEN IT WAS INSTALLED ON THE SYSTEM. THE ISSUE DID NOT OCCUR WITH THE SURGEON¿S HEAD INSIDE THE SURGEON CONSOLE¿S HIGH RESOLUTION STEREO VIEWER. THE ISSUE DID NOT OCCUR WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SURGEON CONSOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065860 ↗
• InjuryJul 17, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, WHEN ATTEMPTING TO SEPARATE THE BRONCHUS OF S6, A TISSUE TOO THICK TO CONTINUE (TTTC) MESSAGE OCCURRED AND THE FIRE STOPPED. UPON OPENING THE JAWS, A B-SHAPED FORMED STAPLE AND A FRAGMENT OF DEBRIS FELL ON THE BRONCHUS. THE TISSUE WAS NOT DISSECTED, AND THERE WAS NO BLEEDING. THE DOCTOR MENTIONED THAT THE DEBRIS MIGHT HAVE PREVENTED THE FIRE FROM COMPLETING. THIS RELOAD WAS THE SECOND FIRE WITHIN THE PROCEDURE. THE FIRST FIRE WAS COMPLETED WITHOUT ISSUES. AFTER THE INCIDENT, A NEW SUREFORM 45 STAPLER AND GREEN RELOAD WERE USED, AND THE FIRE WAS COMPLETED WITHOUT PROBLEMS. THE DEBRIS WILL BE RETURNED TOGETHER WITH THE RELOAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532869 ↗
• MalfunctionJun 10, 2025Firing Problem; Firing Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176356 ↗
• InjuryJun 3, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY PROCEDURE, TWO PARTIAL STAPLER FIRES OCCURRED, INVOLVING A SUREFORM 45 CURVED-TIP STAPLER EQUIPPED WITH GREEN SUREFORM 45 RELOADS. THE FIRST PARTIAL STAPLER FIRE STOPPED AFTER APPROXIMATELY 32MM OF STAPLE LINE WHEN TISSUE BEGAN TO PUSH FORWARD OUT OF THE STAPLER INSTRUMENT'S JAWS. THE SYSTEM THEN DISPLAYED THE ERROR MESSAGE: ¿TISSUE TOO THICK TO CONTINUE.¿ THE STAPLES THAT WERE DEPLOYED WERE BARELY ENGAGED IN THE PATIENT¿S TISSUE AND THE TISSUE WAS NOT TRANSECTED. TO RESOLVE THE ISSUE, A SECOND GREEN SUREFORM 45 RELOAD WAS USED; HOWEVER, A SECOND PARTIAL STAPLER FIRE OCCURRED AGAIN, RESULTING WITH TISSUE BEING PUSHED WITHOUT BEING PROPERLY CUT, AND AN ERROR MESSAGE. THE SURGEON THEN OPTED TO USE A BLACK SUREFORM 45 RELOAD, AND THE STAPLE LINE WAS COMPLETED. THERE WAS NO BLEEDING AND NO ADDITIONAL TISSUE WAS REMOVED. THE PROCEDURE WAS COMPLETED ROBOTICALLY AND THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22137881 ↗
• MalfunctionMay 16, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, CUSTOMER REPORTED THAT THE LOT COULD NOT BE CHECKED BECAUSE THE STAPLER LOAD DID NOT COME OFF OR WAS DIRTY. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED AFTER THE FIRST FIRE, AND THE INSTRUMENT INITIALLY WORKED. A RECTAL TRANSECTION WAS BEING PERFORMED AT THE TIME OF THE EVENT. THE TISSUE WAS NOT CALCIFIED OR EXPOSED TO RADIATION OR CHEMOTHERAPY PRIOR TO THE PROCEDURE. THERE WAS NO TISSUE TENSION OR BUNCHING. THE CUSTOMER NOTED THAT WHILE ATTEMPTING TO REMOVE THE RELOAD FROM OUTSIDE THE BODY FOLLOWING FIRING, IT WOULD NOT COME OFF. THE EVENT DID NOT INVOLVE A FAILURE TO FIRE OR PARTIAL FIRE, NOR DID IT INVOLVE TISSUE BEING PUSHED FORWARD/DRAGGED OR THE STAPLER JAWS OPENING/RELEASING DURING THE FIRING PROCESS. NO STAPLES WERE DEPLOYED UNEXPECTEDLY. THE STAPLING ISSUE DID NOT RESULT IN ANY MALFORMED OR UNFORMED STAPLES, EXPOSED BLADE, STAPLES MISSING FROM THE STAPLE LINE THAT FIRED, HOLES/GAPS, OR RELOAD STUCK TO THE TISSUE. NO ERROR MESSAGES WERE DISPLAYED. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22040679 ↗
• InjuryApr 30, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOWER ANTERIOR RESECTION PROCEDURE, A PIECE OF A GREEN SUREFORM 45 RELOAD WAS FOUND WITHIN THE PATIENT'S BODY CAVITY. THE SIZE OF THE BROKEN PIECE IS ESTIMATED TO BE APPROXIMATELY 2 MM IN SIZE. TWO FIRES WERE MADE WITH GREEN SUREFORM 45 RELOADS IN THIS PROCEDURE. AFTER THE SECOND FIRE FOR DISSECTION OF THE RECTUM, A BROKEN PIECE OF THE STAPLER RELOAD SUDDENLY CAME INTO VIEW. THE SURGEON TRIED TO RETRIEVE THE FRAGMENT FROM THE ASSIST PORT USING THE ASSISTANT FORCEPS, BUT WAS UNSUCCESSFUL. AFTERWARDS, THE ABDOMEN WAS LAVAGED AND THE ASSIST PORT WAS DISASSEMBLED, BUT NO FRAGMENT COULD BE FOUND. THE PROCEDURE WAS ENDED. IT WAS INITIALLY REPORTED THAT THE BASE OF THE STAPLER RELOAD MIGHT HAVE BEEN DAMAGED, BUT THE SURGICAL STAFF STATED THAT THEY COULD NOT DETERMINE WHICH PART WAS DAMAGED. BOTH TIMES, THERE WERE NO ISSUES WITH THE STAPLING FUNCTION, AND THE STAPLING WAS COMPLETED SUCCESSFULLY. THERE WERE NO ABNORMALITIES WHEN ATTACHING THE TWO SUREFORM 45 RELOADS TO THE SUREFORM 45 STAPLER INSTRUMENT, AND THEY CLICKED INTO PLACE WITHOUT ANY PROBLEMS. CURRENTLY, THE PATIENT HAS NOT EXPERIENCED ANY HEALTH ISSUES. NO ADDITIONAL TESTS HAVE BEEN

  Patient problems: Foreign Body In Patient

  MAUDE report 21937526 ↗
• MalfunctionApr 28, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON HAD A HARD TIME STAPLING THE SIGMOID DURING THE CASE. CUSTOMER USED TWO DIFFERENT SUREFORM 45 STAPLERS, 1-WHITE RELOAD, 2-BLUE RELOADS, 2-BLACK RELOADS, AND 7-GREEN RELOADS BEFORE THE STAPLER WOULD HAVE A PROPER SEAL AND FIRE ACROSS THE SIGMOID. THE CUSTOMER CALLED THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR), WHO CALLED THE TECHNICAL SERVICES ENGINEER (TSE). THE TSE ADVISED THAT THEY SHOULD TRY A DIFFERENT STAPLER AND RELOADS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WITH THE VARIOUS RELOADS OCCURRED DURING THE SAME PROCEDURE ON (B)(6) 2025. THE SURGEON HAD ISSUES FIRING THE STAPLER. THE SURGEON USED GREEN, BLUE, WHITE AND BLACK RELOADS BASED ON TISSUE THICKNESS. THE SURGEON COULD NOT UNDERSTAND WHY THE RELOADS WERE NOT FIRING. THERE WERE NO MALFORMED STAPLES, NO HOLES OR GAPS, AND NO INCOMPLETE STAPLE LINE. THE BLADE WAS NOTICED TO BE EXPOSED HOWEVER NO ERROR MESSAGE WAS GENERATED. THE DELAY WAS ABOUT 15 MINUTES WHILE TRYING A DIFFERENT COLOR RELOAD. THERE WAS NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21923371 ↗
• InjuryApr 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOWER ANTERIOR RESECTION PROCEDURE A PIECE OF THE GREEN RELOAD WAS FOUND WITHIN THE BODY CAVITY. THE SIZE OF THE BROKEN PIECE IS ESTIMATED TO BE APPROXIMATELY 2 MM. TWO FIRES WERE MADE WITH SUREFORM 45 GREEN RELOADS IN THIS PROCEDURE. AFTER THE SECOND FIRE FOR DISSECTION OF THE RECTUM, A BROKEN PIECE OF THE RELOAD SUDDENLY CAME INTO VIEW. THE SURGEON TRIED TO RETRIEVE THE FRAGMENT FROM THE ASSIST PORT USING THE ASSISTANT FORCEPS, BUT IT WAS GONE SOMEWHERE WHEN THE ASSISTANT FORCEPS WAS REMOVED OUT OF THE ASSISTANT PORT. AFTER THAT, THEY PERFORMED AN ABDOMINAL LAVAGE, AND THE ASSIST PORT WAS DISASSEMBLED, BUT NO FRAGMENT COULD BE FOUND, AND THE PROCEDURE WAS ENDED. IT WAS INITIALLY REPORTED THAT THE BASE OF THE RELOAD MIGHT BE DAMAGED, BUT THE SITE STAFF STATED THAT THEY COULD NOT DETERMINE WHICH PART WAS DAMAGED. BOTH TIMES, THERE WERE NO ISSUES WITH THE STAPLING FUNCTION, AND THE STAPLING WAS COMPLETED SUCCESSFULLY. THERE WERE NO ABNORMALITIES WHEN ATTACHING THE TWO RELOADS TO THE INSTRUMENT, AND THEY CLICKED INTO PLACE WITHOUT ANY PROBLEMS. CURRENTLY, THE PATIENT HAS NOT EXPERIENCED ANY HEALTH ISSUES. NO ADDITIONAL TESTS HAVE BEEN C

  Patient problems: Foreign Body In Patient

  MAUDE report 21909370 ↗
• InjuryMar 5, 2025Failure to Form Staple; Firing Problem; Failure to Form Staple; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROXIMAL GASTRECTOMY PROCEDURE, A PARTIAL STAPLER FIRE OCCURRED WHILE FIRING A GREEN SUREFORM 45 RELOAD WITH A SUREFORM 45 STAPLER INSTRUMENT. TISSUE WAS PUSHED FORWARD/DRAGGED DURING THE STAPLER FIRING PROCESS TO CREATE THE ANASTOMOSIS. THE ERROR OCCURRED ON THE FIRST STAPLER FIRE, DISPLAYING A "TISSUE TOO THICK TO CONTINUE" MESSAGE. ADDITIONALLY, THE STAPLER RELOAD HAD AN EXPOSED BLADE, MALFORMED/UNFORMED STAPLES WERE OBSERVED, AND THE STPALE LINE HAD MISSING STAPLES. THERE WAS NO REPORTED BLEEDING. THE STAPLER INSTRUMENT WAS REMOVED AND UPON RELOADING THE STAPLER, A DENT WAS OBSERVED. NO OBSTRUCTIONS SUCH AS CLIPS, STAPLES, OR OTHER HARD MATERIALS WERE FOUND BETWEEN THE INSTRUMENT JAWS. THE INSTRUMENT HAD BEEN INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY THAT WAS NOTED. THE ISSUE WAS RESOLVED BY USING A SECOND GREEN SUREFORM 45 RELOAD WITH THE SAME STAPLER INSTRUMENT. NO ADDITIONAL TISSUE REMOVAL WAS NECESSARY, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21531348 ↗
• MalfunctionJan 7, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8 MM SUREFORM 45 STAPLER INSTRUMENT WAS USED FOR A SURGICAL TASK AND DID NOT RECOGNIZE THE GREEN RELOAD. IT RECOGNIZED IT AS A BLACK RELOAD. USE OF THE INSTRUMENT WAS DISCONTINUED, AND IT WAS REPLACED TO THE BACKUP. THE USER COMPLETED THE PROCEDURE USING THE SAME SYSTEM. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21097659 ↗
• InjuryOct 16, 2024Failure to Form Staple; Detachment of Device or Device Component; Firing Problem; Failure to Form Staple; Detachment of Device or Device Component; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THERE WAS A PROBLEM WITH STAPLING THE COLON USING THE SUREFORM 45 AND 60 STAPLERS WITH THE SUREFORM GREEN 45 AND 60 RELOADS. STAPLING OF THE COLON WAS NOT SUCCESSFUL, AND CHARGING STOPPED HALFWAY, PREVENTING NORMAL USE OF THE DEVICE. THERE WAS A MESSAGE ON THE DA VINCI CONSOLE NOTING, "TISSUE TOO THICK FOR STAPLING" DESPITE NORMAL TISSUE SIZE. THERE WAS NO PATIENT CONSEQUENCE, BUT THEY NOTED THAT IT WAS A VERY COMPLICATED SITUATION AT THE TIME. PRIOR TO CALLING TECHNICAL SUPPORT, THE SITE ALREADY TRIED TO USE TWO INSTRUMENTS WITH BLUE AND BLACK RELOADS. THE REPORTER STATED THAT THE SURGEON WAS EXPERIENCED WITH THIS KIND OF INSTRUMENTS/USE. WHEN THE SURGEON WAS USING THE STAPLER, BOTH STAPLING AND CUTTING ENDED MID-COURSE, STATED THE CALLER. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOUND NOTHING RELEVANT IN THE LOGS. THE TSE ASKED THE CUSTOMER TO RESEAT THE STERILE ADAPTER (SA) PRIOR TO RETRYING WITH THE SUREFORM STAPLER, BUT THE BEHAVIOR REMAINED. THE CALLER STATED THAT THE ROBOTIC PART OF THE PROCEDURE WAS NOW COMPLETED. THE PROCEDURE WAS CONTINUING AS PLANNED. INT

  Patient problems: Foreign Body In Patient

  MAUDE report 20459226 ↗
• InjuryOct 16, 2024Failure to Form Staple; Detachment of Device or Device Component; Firing Problem; Failure to Form Staple; Detachment of Device or Device Component; Firing Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 20459191 ↗