SureForm 48360TRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00886874113851), received between Sep 30, 2021 and Jul 29, 2026 — classified as 17 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Firing Problem” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryJul 29, 2026Firing Problem

  It was reported that during a da Vinci-assisted sleeve gastrectomy procedure, a partial fire occurred when the surgeon fired a SureForm 60 Blue Reload with a SureForm 60 Stapler instrument. As a result, the customer replaced the SureForm 60 Blue Reload with a SureForm 60 Black Reload. When attempting to fire the SureForm 60 Black Reload, the customer encountered a tissue too thick message issue. The customer replaced the SureForm 60 Stapler instrument and SureForm 60 Black Reload, and was eventually able to fire normally. Although the customer indicated that the staple line(s) did not have any missing staples or holes/gaps, the staple line had to be re-done or re-stapled. The procedure was completed robotically. The customer confirmed that no fragments fell inside the patient. However, the customer removed unformed staples from the surgical field. It is unclear if the unformed staples originated from the SureForm 60 Black and/or Blue Reload(s).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50077692 ↗
• InjuryAug 20, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, HOLES/GAPS WERE OBSERVED WITHIN THE STAPLE LINE WHERE A BLACK SUREFORM 60 RELOAD WAS PARTIALLY FIRED WITH A SUREFORM 60 STAPLER INSTRUMENT. STAPLES WERE MISSING FROM THE INTENDED STAPLE LINE. THE CUSTOMER STATED AN EXPOSED BLADE MESSAGE AND AN UNABLE TO FIRE MESSAGE WERE OBSERVED WHEN ATTEMPTING TO FIRE THE BLACK SUREFORM 60 RELOAD. THE SURGEON WAS PERFORMING A LUNG WEDGE RESECTION AT THE TIME THIS EVENT OCCURRED; THE TISSUE WAS NOT CALCIFIED ADN THERE WAS NO BUNCHING OF TISSUE. THE CUSTOMER THEN TRIED OTHER SUREFORM 60 STAPLER INSTRUMENTS WITH BLACK SUREFORM 60 RELOADS WITH NO SUCCESS. IT WAS REPORTED THAT THIS EVENT OCCURRED WITH THE USE OF SEVERAL SUREFORM STAPLER INSTRUMENTS AND BLACK SUREFORM RELOADS DURING THIS PROCEDURE. THE CUSTOMER DID NOT ENCOUNTER ANY OBSTRUCTIONS SUCH AS CLIPS, STAPLES, OR OTHER HARD MATERIAL BETWEEN THE INSTRUMENT JAWS NOR DID THEY ATTEMPT TO FIRE OVER AN EXISTING STAPLE LINE. EVENTUALLY, THE CUSTOMER WAS ABLE TO INSTALL A SUREFORM 45 STAPLER INSTRUMENT AND SUCCESSFULLY FIRED A BLACK SUREFORM 45 RELOAD TO COMPLETE THE PROCEDURE. THE CUSTOMER REPORTED NO PATIENT HARM OR INJUR

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22854568 ↗
• InjuryAug 20, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, HOLES/GAPS WERE OBSERVED WITHIN THE STAPLE LINE WHERE A BLACK SUREFORM 60 RELOAD WAS PARTIALLY FIRED WITH A SUREFORM 60 STAPLER INSTRUMENT. STAPLES WERE MISSING FROM THE INTENDED STAPLE LINE. THE CUSTOMER STATED AN EXPOSED BLADE MESSAGE AND AN UNABLE TO FIRE MESSAGE WERE OBSERVED WHEN ATTEMPTING TO FIRE THE BLACK SUREFORM 60 RELOAD. THE SURGEON WAS PERFORMING A LUNG WEDGE RESECTION AT THE TIME THIS EVENT OCCURRED; THE TISSUE WAS NOT CALCIFIED ADN THERE WAS NO BUNCHING OF TISSUE. THE CUSTOMER THEN TRIED OTHER SUREFORM 60 STAPLER INSTRUMENTS WITH BLACK SUREFORM 60 RELOADS WITH NO SUCCESS. IT WAS REPORTED THAT THIS EVENT OCCURRED WITH THE USE OF SEVERAL SUREFORM STAPLER INSTRUMENTS AND BLACK SUREFORM RELOADS DURING THIS PROCEDURE. THE CUSTOMER DID NOT ENCOUNTER ANY OBSTRUCTIONS SUCH AS CLIPS, STAPLES, OR OTHER HARD MATERIAL BETWEEN THE INSTRUMENT JAWS NOR DID THEY ATTEMPT TO FIRE OVER AN EXISTING STAPLE LINE. EVENTUALLY, THE CUSTOMER WAS ABLE TO INSTALL A SUREFORM 45 STAPLER INSTRUMENT AND SUCCESSFULLY FIRED A BLACK SUREFORM 45 RELOAD TO COMPLETE THE PROCEDURE. THE CUSTOMER REPORTED NO PATIENT HARM OR INJUR

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22854540 ↗
• InjuryAug 20, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, HOLES/GAPS WERE OBSERVED WITHIN THE STAPLE LINE WHERE A BLACK SUREFORM 60 RELOAD WAS PARTIALLY FIRED WITH A SUREFORM 60 STAPLER INSTRUMENT. STAPLES WERE MISSING FROM THE INTENDED STAPLE LINE. THE CUSTOMER STATED AN EXPOSED BLADE MESSAGE AND AN UNABLE TO FIRE MESSAGE WERE OBSERVED WHEN ATTEMPTING TO FIRE THE BLACK SUREFORM 60 RELOAD. THE SURGEON WAS PERFORMING A LUNG WEDGE RESECTION AT THE TIME THIS EVENT OCCURRED; THE TISSUE WAS NOT CALCIFIED ADN THERE WAS NO BUNCHING OF TISSUE. THE CUSTOMER THEN TRIED OTHER SUREFORM 60 STAPLER INSTRUMENTS WITH BLACK SUREFORM 60 RELOADS WITH NO SUCCESS. IT WAS REPORTED THAT THIS EVENT OCCURRED WITH THE USE OF SEVERAL SUREFORM STAPLER INSTRUMENTS AND BLACK SUREFORM RELOADS DURING THIS PROCEDURE. THE CUSTOMER DID NOT ENCOUNTER ANY OBSTRUCTIONS SUCH AS CLIPS, STAPLES, OR OTHER HARD MATERIAL BETWEEN THE INSTRUMENT JAWS NOR DID THEY ATTEMPT TO FIRE OVER AN EXISTING STAPLE LINE. EVENTUALLY, THE CUSTOMER WAS ABLE TO INSTALL A SUREFORM 45 STAPLER INSTRUMENT AND SUCCESSFULLY FIRED A BLACK SUREFORM 45 RELOAD TO COMPLETE THE PROCEDURE. THE CUSTOMER REPORTED NO PATIENT HARM OR INJUR

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22854397 ↗
• InjuryAug 20, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, HOLES/GAPS WERE OBSERVED WITHIN THE STAPLE LINE WHERE A BLACK SUREFORM 60 RELOAD WAS PARTIALLY FIRED WITH A SUREFORM 60 STAPLER INSTRUMENT. STAPLES WERE MISSING FROM THE INTENDED STAPLE LINE. THE CUSTOMER STATED AN EXPOSED BLADE MESSAGE AND AN UNABLE TO FIRE MESSAGE WERE OBSERVED WHEN ATTEMPTING TO FIRE THE BLACK SUREFORM 60 RELOAD. THE SURGEON WAS PERFORMING A LUNG WEDGE RESECTION AT THE TIME THIS EVENT OCCURRED; THE TISSUE WAS NOT CALCIFIED ADN THERE WAS NO BUNCHING OF TISSUE. THE CUSTOMER THEN TRIED OTHER SUREFORM 60 STAPLER INSTRUMENTS WITH BLACK SUREFORM 60 RELOADS WITH NO SUCCESS. IT WAS REPORTED THAT THIS EVENT OCCURRED WITH THE USE OF SEVERAL SUREFORM STAPLER INSTRUMENTS AND BLACK SUREFORM RELOADS DURING THIS PROCEDURE. THE CUSTOMER DID NOT ENCOUNTER ANY OBSTRUCTIONS SUCH AS CLIPS, STAPLES, OR OTHER HARD MATERIAL BETWEEN THE INSTRUMENT JAWS NOR DID THEY ATTEMPT TO FIRE OVER AN EXISTING STAPLE LINE. EVENTUALLY, THE CUSTOMER WAS ABLE TO INSTALL A SUREFORM 45 STAPLER INSTRUMENT AND SUCCESSFULLY FIRED A BLACK SUREFORM 45 RELOAD TO COMPLETE THE PROCEDURE. THE CUSTOMER REPORTED NO PATIENT HARM OR INJUR

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22854393 ↗
• InjuryAug 20, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, HOLES/GAPS WERE OBSERVED WITHIN THE STAPLE LINE WHERE A BLACK SUREFORM 60 RELOAD WAS PARTIALLY FIRED WITH A SUREFORM 60 STAPLER INSTRUMENT. STAPLES WERE MISSING FROM THE INTENDED STAPLE LINE. THE CUSTOMER STATED AN EXPOSED BLADE MESSAGE AND AN UNABLE TO FIRE MESSAGE WERE OBSERVED WHEN ATTEMPTING TO FIRE THE BLACK SUREFORM 45 RELOAD. THE SURGEON WAS PERFORMING A LUNG WEDGE RESECTION AT THE TIME THIS EVENT OCCURRED; THE TISSUE WAS NOT CALCIFIED ADN THERE WAS NO BUNCHING OF TISSUE. THE CUSTOMER THEN TRIED OTHER SUREFORM 60 STAPLER INSTRUMENTS WITH BLACK SUREFORM 60 RELOADS WITH NO SUCCESS. IT WAS REPORTED THAT THIS EVENT OCCURRED WITH THE USE OF SEVERAL SUREFORM STAPLER INSTRUMENTS AND BLACK SUREFORM RELOADS DURING THIS PROCEDURE. THE CUSTOMER DID NOT ENCOUNTER ANY OBSTRUCTIONS SUCH AS CLIPS, STAPLES, OR OTHER HARD MATERIAL BETWEEN THE INSTRUMENT JAWS NOR DID THEY ATTEMPT TO FIRE OVER AN EXISTING STAPLE LINE. EVENTUALLY, THE CUSTOMER WAS ABLE TO INSTALL A SUREFORM 45 STAPLER INSTRUMENT AND SUCCESSFULLY FIRED A BLACK SUREFORM 45 RELOAD TO COMPLETE THE PROCEDURE. THE CUSTOMER REPORTED NO PATIENT HARM OR INJUR

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22854392 ↗
• MalfunctionMar 25, 2025Break; Break

  IT WAS REPORTED THAT OUT OF BOX, THE SILVER METAL HOUSING WAS OBSERVED TO NOT BE ATTACHED TO THE BLACK SUREFORM 60 STAPLER RELOAD. NO REPORT OF PATIENT INVOLVEMENT OR NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21692590 ↗
• MalfunctionMay 21, 2024Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC SLEEVE SURGICAL PROCEDURE, THE SUREFORM STAPLER INSTRUMENT INSTALLED WITH A BLACK RELOAD FAILED TO FIRE COMPLETELY LEAVING THE BLADE EXPOSED. AT THE TIME OF THE FIRING, THE SYSTEM PROMPTED TO PAUSE TO REASSESS THE TISSUE THICKNESS. A GORE SEAMGAURD STAPLE LINE REINFORCEMENT WAS PLACED OVER THE BLACK RELOAD BEFORE THE INSERTION OF THE STAPLER. THE SITE WAS ABLE TO REMOVE THE RELOAD WITHOUT FURTHER INCIDENT AND ANOTHER BLACK RELOAD WAS USED TO COMPLETE THE STAPLING OF THE STOMACH. THERE WAS NO REPORTED FRAGMENT THAT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH THE SITE'S INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED PRIOR TO THE ISSUE, AND NOTHING OUT OF THE ORDINARY WAS NOTED. THE RELOAD COLOR INVOLVED WITH THE REPORTED EVENT WAS THE BACK RELOAD. THE BLACK RELOAD WAS PICKED DUE TO THE THICKNESS OF THE TISSUE. THE ISSUE HAPPENED AT THE THIRD STAPLE FIRE. THE TASK BEING PERFORMED AT THE TIME OF THE ISSUE WAS WHILE STAPLING THE STOMACH. THE TISSUE WAS NOT NOTED TO BE CALCIFIED, EXPOSED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19362054 ↗
• MalfunctionJan 8, 2024Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, SUREFORM 60 STAPLER BLACK RELOAD ONLY FIRED 9 TIMES OUT OF IT'S INTENDED 12. UPON LOADING IT AFTER THE 9TH FIRE THE SUREFORM BLACK RELOAD WOULD NOT FIRE. THE CUSTOMER REMOVED THE STAPLER INSTRUMENT AND CONTINUED WITH ANOTHER OF THE SAME. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY OR DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18469900 ↗
• MalfunctionJan 5, 2024Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, SUREFORM 60 STAPLER ONLY FIRED 9 TIMES OUT OF IT'S INTENDED 12. UPON LOADING IT AFTER THE 9TH FIRE THE SUREFORM WOULD NOT FIRE. THE CUSTOMER REMOVED THE STAPLER AND CONTINUED WITH ANOTHER OF THE SAME. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY OR DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18460838 ↗
• InjuryDec 1, 2023Failure to Form Staple; Failure to Form Staple

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18246215 ↗
• MalfunctionNov 15, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION SURGICAL PROCEDURE, THE SUREFORM STAPLER 60 BLACK RELOAD STOPPED FIRING UNEXPECTEDLY. THE TARGET TISSUE WAS THE LUNG. THE RELOAD AND STAPLER WERE REMOVED FROM THE STERILE FIELD, AND IT SHOWS THAT ONLY HALF OF THE STAPLE LOAD WAS FIRED CORRECTLY. THE CUSTOMER OPENED NEW STAPLE AND NEW STAPLER TO COMPLETE THE JOB. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A BACK UP INSTRUMENT. THERE WAS NO HARM OR INJURY TO THE PATIENT. NO FRAGMENTS FELL INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142700 ↗
• InjuryJun 12, 2023Failure to Form Staple; Failure to Form Staple

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17108770 ↗
• MalfunctionJun 5, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A DA-VINCI ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE CUSTOMER HAD ISSUES WITH THE EXPOSED BLADE ERROR MESSAGE WHEN USING THE STAPLER 60 INSTRUMENT. THE STAPLE LINE WAS ROBOTICALLY FINISHED WITH A NEEDLE DRIVER INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. THE STAPLER WAS INSPECTED PRIOR TO USE AND NOTHING UNUSUAL WAS NOTED. THE SURGEON WAS ATTEMPTING TO STAPLE SOFT INTESTINAL TISSUE. THE STAPLER EXPERIENCED A BLADE EXPOSED ERROR ON THE SYSTEM PARTWAY THROUGH THE STAPLING. THE STAPLER INSTRUMENT WORKED PARTIALLY. THE SURGEON USED BLACK AND GREEN RELOADS WITH THE SAME ISSUE. THE STAPLER WAS ONLY BRIEFLY IN USE AS THE ISSUE OCCURED WITH THE FIRST STAPLE FIRE. THE SURGEON DID NOT ENCOUNTER ANY OBSTRUCTIONS AND NO BUTTRESS MATERIAL WAS USED. THERE WERE NO MALFORMED STAPLES AND NO CLAMPING ISSUES PRIOR TO FIRING. INTESTINAL TISSUE WAS TARGET TISSUE. NO TISSUE WAS STUCK ON THE RELOAD OR THE STAPLER. THE SURGEON WAS ABLE TO REMOVE THE PARTIAL STAPLE LINE AND SEW IT UP ROBOTICALLY USING A NEEDLE DRIVER INSTRUMENT. THERE WAS NO EXCESSIVE BLEEDING AND NO LEAKING. THE TISSUE WAS NOT CALCIFIED NOR EXPOSED TO RADIATION. THERE WAS NO TISSU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067437 ↗
• MalfunctionJun 1, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THERE WAS A BLADE EXPOSED EVENT WHEN THE SUREFORM STAPLER WAS USED. THERE WERE NO ERRORS ON SYSTEM LOG REVIEW. THIS WAS THE 2ND FIRING OF THIS SUREFORM 60 DURING THE PROCEDURE AND A BLACK RELOAD WITH BUTTRESS MATERIAL WAS USED. THE STAPLER PAUSED FOR COMPRESSION THREE TIMES DURING THIS FIRE AND FINALLY GAVE A BLADE EXPOSED ERROR MESSAGE. THE SURGEON REPORTED NOT NOTICING ANYTHING ABNORMAL WITH THE STAPLER INSTRUMENT, RELOAD, OR TISSUE AND DID NOT EXPECT ANY ISSUES. THE SURGEON REPORTED TYPICALLY GETTING SOME PAUSES FOR COMPRESSION WHEN FIRING ON THIS TISSUE BUT HAS NEVER EXPERIENCED A BLADE EXPOSED ERROR WHILE FIRING ON THIS TISSUE. THE SURGEON UNCLAMPED THIS SUREFORM 60 AND INSTALLED A NEW DA VINCI STAPLER AND RELOAD. THE SURGEON LINED UP THIS STAPLER WITH THE INCOMPLETE PREVIOUS STAPLE LINE AND FIRED TO COMPLETE THE LINE. NO FURTHER ISSUES WERE EXPERIENCED DURING THIS PROCEDURE. THE SURGEON REPORTED THAT THERE WERE NO PATIENT COMPLICATIONS, BUT SHE WAS CONCERNED ABOUT A POTENTIAL FUTURE LEAK DUE TO THIS EVENT. A LEAK TEST WAS PERFORMED AFTER THIS PROCEDURE AND THE RESULTS WERE NEGATIVE. THE PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038551 ↗
• InjuryMay 27, 2023Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE SUREFORM 60 STAPLER INSTRUMENT INSTALLED WITH THE BLACK RELOAD WAS USED FOR BRONCHIAL DISSECTION. AFTER STAPLE FIRE, THREE OUTER STAPLES WERE NOT FORMED AND CAME OFF. AT THE TIME OF THE ISSUE, THE USER STATED THAT THE SYSTEM DISPLAYED THE "TISSUE TOO THICK TO CONTINUE" PROMPT. THE SURGEON STATED THAT THE TISSUE BEING STAPLED WAS THICK. TROUBLESHOOTING WAS PERFORMED BY REPLACING INTO ANOTHER INSTRUMENT TO COMPLETE THE SURGICAL TASK AND THIS RESOLVED THE ISSUE. FOLLOWING THIS, THE USER CONTINUED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INTO THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: INSPECTION WAS CONDUCTED PRIOR TO USE. AT THE TIME OF THE EVENT, USER CONFIRMED THAT THE TISSUE TOO THICK TO CONTINUE WAS DISPLAYED AND B TYPE MALFORMED STAPLES WERE FOUND. THE SURGEON USED 3RD PARTY DEVICE (TACHOSIL TISSUE SEALING SHEET). NO STAPLE LINE LEAKAGE CONFIRMED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17015664 ↗
• MalfunctionOct 24, 2022Output Problem; Output Problem

  THE SUREFORM 60 BLACK RELOAD WAS AN INCIDENTAL RETURN WITH A SUREFORM 60 STAPLER FOR A FAILURE TO GRIP ISSUE. NO ALLEGATION WAS MADE AGAINST THE SUREFORM 60 BLACK RELOAD. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656870 ↗
• InjuryJun 28, 2022Misfire; Misfire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER INDICATED THAT THE TISSUE WAS TOO THICK, EVEN AFTER USING THE BLACK STAPLER RELOADS. THE TARGET TISSUE WAS REPORTED AS LUNG AND THERE WAS NO TISSUE TENSION OR TISSUE BUNCHING DURING THE STAPLER CLAMPING SEQUENCE. THE PROCEDURE WAS CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY. AN ERROR MESSAGE: "TISSUE TOO LARGE" WAS GENERATED WHEN THE STAPLING ISSUE OCCURRED. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SITE¿S ROBOTICS COORDINATOR: THE PROCEDURE WAS CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY BECAUSE THE ISSUE OCCURRED TOWARDS THE END OF THE CASE AND THE SURGEON DIDN'T WANT TO OPEN UP A NEW STAPLER INSTRUMENT. THE STAPLER SUCCESSFULLY FIRED A FEW TIMES, THEN WOULD EITHER FIRE SUCCESSFULLY DURING THE CASE OR NOT FIRE AT ALL. THE STAPLER DID NOT PARTIALLY FIRE AND THERE WERE NO MALFORMED STAPLES. AFTER FIRING, THE PATIENT'S TISSUE WOULD STICK TO THE STAPLER. THE SURGEON USED THE STAPLER'S MANUAL RELEASE KNOB (MRK) TO SEPARATE THE STAPLER FROM THE PATIENT'S TISSUE. BLEEDING WAS OBSERVED DURING THE PROCEDURE AND BLOOD LOSS VOLUM

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14847888 ↗
• InjuryJun 27, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) PROCEDURE, THE SURGEON ENCOUNTERED A ¿TISSUE TOO THICK¿ MESSAGE WHILE ATTEMPTING TO FIRE A GREEN SUREFORM STAPLER 60 RELOAD WITH A SUREFORM STAPLER 60 INSTRUMENT. THE SURGEON REPORTEDLY HAD THE SAME RESULT AFTER ATTEMPTING TO FIRE TWO BLACK SUREFORM STAPLER 60 RELOADS. FOR AN UNCLEAR REASON, THE SURGEON WAS UNABLE TO RECONSTRUCT THE ANASTOMOSIS. AS A RESULT, A RECTAL AMPUTATION WAS PERFORMED. THE CASE WAS REPORTEDLY CONVERTED TO OPEN SURGERY. ON 07-SEP-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: WHILE THE SURGEON WAS ATTEMPTING TO FIRE A GREEN SUREFORM 60 RELOAD, A "TISSUE TOO THICK" MESSAGE WAS GENERATED BY THE SYSTEM. AS A RESULT, IT WAS ALLEGED THAT A PARTIAL FIRE OCCURRED, THE STAPLE LINE WAS INCOMPLETE, AND THE RECTUM COULD NOT BE DISSECTED. THE SURGEON MENTIONED THAT HE OBSERVED FREE STAPLES AT THE END OF THE STAPLE LINE; HOWEVER, HE COULD NOT RECALL FINDING ANY MALFORMED STAPLES. THE TARGETED TISSUE WAS NOT DAMAGED. AFTER THE FIRST FIRING ATTEMPT WITH THE GREEN SUREFORM 60 RELOAD, THE SURGEON ATTEMPTED TO FIRE TWO BLACK SUREFORM ST

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14825708 ↗
• InjuryMay 26, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE SURGEON FIRED A BLACK SUREFORM 60 RELOAD WITH A SUREFORM 60 STAPLER INSTRUMENT AND ON THE OUTER ROW, ONE STAPLE WAS FOUND TO BE STICKING STRAIGHT UP AND DID NOT CURL BACK. THE SURGEON CUT THE STAPLE OUT AND OVERSEWED THAT AREA. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE PHYSICIAN. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14515778 ↗
• InjuryMay 16, 2022Failure to Cut; Failure to Fire; Failure to Cut; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BARIATRIC REVISION SURGICAL PROCEDURE, A SUREFORM 60 STAPLER INSTRUMENT WAS USED WITH GREEN SUREFORM 60 RELOADS, BUT ¿TISSUE TOO THICK¿ ERROR MESSAGES WERE RECEIVED. THE SURGEON THEN USED A BLACK SUREFORM 60 RELOAD WITH THE SUREFORM 60 STAPLER INSTRUMENT AFTER THESE ERROR MESSAGES. THE BLACK STAPLER RELOAD REPORTEDLY FIRED, BUT STOPPED HALFWAY. THE SURGEON USED THE FORCE FIRE OPTION TO CONTINUE THIS PARTIAL FIRE; HOWEVER, THE TARGET TISSUE WAS PUSHED INSTEAD OF CUT. AT THAT TIME, THE SURGEON ELECTED TO CONVERT THE PROCEDURE TO TRADITIONAL LAPAROSCOPY. THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY WITH NO REPORTED PATIENT HARM. AFTER THE EVENT OCCURRED, AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND IDENTIFIED STAPLER 45 INSTRUMENT ISSUES ON ARM #4. NO TROUBLESHOOTING WAS PERFORMED DURING THE ROBOTIC PROCEDURE AS THE CUSTOMER DID NOT CALL ISI TECHNICAL SUPPORT AT THE TIME. HOWEVER, THE CUSTOMER REQUESTED FOR AN ISI FIELD SERVICE ENGINEER (FSE) TO FOLLOW UP ON THE ISSUES. ISI PERFORMED MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14412488 ↗
• InjuryMay 14, 2022Failure to Form Staple; Failure to Cut; Failure to Form Staple; Failure to Cut

  IT WAS REPORTED THAT DURING A DAVINCI-ASSISTED BARIATRIC REVISION PROCEDURE, THE TISSUE WAS PUSHED AND NOT CUT WHEN A SUREFORM 60 RELOAD WAS FIRED WITH A SUREFORM 60 INSTRUMENT. THE ISSUE OCCURRED TWO TIMES DURING THE PROCEDURE USING 2 DIFFERENT STAPLER INSTRUMENTS AND RELOADS. THE STAPLING ISSUES OCCURRED DURING THE THIRD AND THE FOURTH STAPLER RELOAD FIRES. AS A RESULT, THE SURGEON STAPLED MEDIAL TO THE INCOMPLETE STAPLE LINE, MAKING THE STOMACH POUCH SMALLER. THE SURGEON STATED THAT FOR THE FIRST STAPLER FIRE, HE USED BUTTRESS MATERIAL WITH A GREEN SUREFORM 60 RELOAD. FOR THE SUBSEQUENT FIRES, HE DOES NOT USE BUTTRESS MATERIAL. THE STOMACH TISSUE WAS PUSHED FORWARD ON THE THIRD STAPLER FIRE WITH A GREEN SUREFORM 60 RELOAD. AFTER THE MISFIRE OCCURRED, THE E-STOP BUTTON WAS PRESSED, AND THE STAPLER WAS OPENED. AT THAT TIME, THERE WAS REPORTEDLY AN UNSPECIFIED ERROR MESSAGE. THE SURGEON THEN UPSIZED TO A BLACK SUREFORM 60 RELOAD AND USED A NEW SUREFORM 60 STAPLER INSTRUMENT. HOWEVER, WHEN THE BLACK STAPLER RELOAD WAS FIRED, THE TISSUE WAS PUSHED OUT AND NOT CUT AGAIN. IT WAS OBSERVED THAT THERE WERE A LOT OF MALFORMED STAPLES DUMPED. THE E-STOP BUTTON WAS PRESSED AGAIN. THE SURGEON

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14403439 ↗
• InjuryApr 22, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION PROCEDURE, THE SUREFORM 60 STAPLER INSTRUMENT MADE A LOUD UNSPECIFIED SOUND AND THE TARGET TISSUE MOVED WHILE A STAPLER RELOAD WAS BEING FIRED. AS A RESULT, THERE WAS AN INCOMPLETE STAPLE LINE. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING THE PROCEDURE, THE SURGEON USED A BLACK SUREFORM 60 STAPLER RELOAD ON LUNG PARENCHYMA FOR THE FIRST FIRE AND HAD A SUCCESSFUL FIRE. ON THE SECOND FIRE ON LUNG PARENCHYMA, HE USED ANOTHER BLACK SUREFORM 60 STAPLER RELOAD AS WELL. THE SURGEON CLAMPED DOWN IN A WAY TO ENSURE THAT THE STAPLER INSTRUMENT DID NOT CROSS THE INITIAL STAPLE LINE. THE STAPLER INSTRUMENT CLAMPED DOWN WITH NO ISSUES, AND HE THEN FIRED. THERE WERE NO SYSTEM GENERATED ERRORS OR WARNINGS PRIOR TO FIRING. HOWEVER, THERE WAS A LOUD SOUND AND THE TISSUE MOVED AND BUNCHED UP DURING THE FIRING PROCESS. ALL THE STAPLES WERE DUMPED AND NONE WERE IMPLANTED INTO TISSUE. THE STAPLES WERE REPORTEDLY MALFORMED AND NOT IN A B-SHAPE. THE SURGEON THEN USED A THIRD PARTY ECHELON STAPLER TO COMPLETE THE STAPLE LINE. THE SURGEON S

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14190741 ↗
• InjuryMar 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER INSTRUMENT HAD A STAPLING ISSUE. THE STOMACH TISSUE STARTED MOVING/PUSHING WHILE A SUREFORM 60 STAPLER RELOAD WAS BEING FIRED. THE SURGEON ABORTED THE STAPLE FIRE/CUT AND IT WAS THEN ALLEGED THAT THE SUREFORM 60 STAPLER INSTRUMENT COULD NOT BE UNCLAMPED. THE STAPLER INSTRUMENT WAS MANUALLY UNCLAMPED, AND THE SURGEON USED ANOTHER STAPLER INSTRUMENT TO COMPLETE THE PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON STATED HE USED THE SUREFOM 60 STAPLER INSTRUMENT WITH A BLUE SUREFORM 60 RELOAD WHEN ATTEMPTING TO CLAMP THE GREATER CURVATURE OF THE STOMACH. HOWEVER, THERE WERE STAPLING CHALLENGES AND A TISSUE TOO THICK MESSAGE WAS GENERATED. HENCE, THE SURGEON UPSIZED TO A GREEN SUREFROM 60 RELOAD BUT THE SAME ISSUE PERSISTED. THE SURGEON UPSIZED TO A BLACK SUREFORM 60 RELOAD. THERE WERE ISSUES WITH CLAMPING DOWN; HOWEVER, THE BLACK SUREFORM 60 RELOAD FIRED. HE STATED THERE WAS SOME OOZING WHICH IS NORMAL AND EXPECTED AFTER A FIRE AND WAS NOT OF CONCERN. THERE WERE LOOSE ST

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13720832 ↗
• InjurySep 30, 2021Misfire; Misfire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER INSTRUMENT MISFIRED AND DID NOT CUT THE TISSUE. THE TISSUE WAS REPORTEDLY RIPPED. NO FRAGMENT FELL INSIDE THE PATIENT. THE CUSTOMER USED A BACKUP INSTRUMENT TO CONTINUE, AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI CLINICAL SALES REPRESENTATIVE (CSR) ON (B)(6) 2021 AND OBTAINED ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. A BLACK RELOAD WAS INSTALLED IN THE INSTRUMENT AT THE TIME. THE SURGEON WAS STAPLING THE PARENCHYMA WHEN THE REPORTED ISSUE OCCURRED. THE TISSUE WAS BUNCHED UP DURING THE FIRST FIRE OF THE SUREFORM 60 STAPLER INSTRUMENT. DUE TO THE TISSUE BUNCHING, THE STAPLER INSTRUMENT DID NOT MAKE A COMPLETE TRANSECTION AFTER IT WAS FIRED. THE SURGEON NOTED LOOSE STAPLES. THE SURGEON USED A SECOND STAPLER AND FIRED ACROSS THE STAPLE LINE THAT HE DID NOT LIKE. ISI HAS ATTEMPTED TO CONTACT THE SURGEON TO OBTAIN ADDITIONAL INFORMATION, HOWEVER HAS NOT BEEN SUCCESSFUL AS OF THE DATE OF THIS REPORT.

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

  MAUDE report 12554643 ↗