SureForm 48345TRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00886874117118), received between Jun 10, 2021 and Jun 5, 2026 — classified as 10 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Firing Problem” (10 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TRANSTHORACIC ESOPHAGECTOMY PROCEDURE, THE SUREFORM 45 BLACK RELOAD PRODUCED A TISSUE PUSHOUT EVENT TWICE ON STOMACH TISSUE. THE FIRST TISSUE PUSHOUT EVENT OCCURRED WITH THE FIRST SUREFORM 45 STAPLER INSTRUMENT, WHICH HAD MULTIPLE PRIOR SUCCESSFUL RELOAD FIRINGS. WHILE ATTEMPTING TO FIRE A BLACK RELOAD ON STOMACH TISSUE, THE TISSUE WAS PUSHED OUT ALONG WITH THE STAPLES OUT OF THE JAWS OF THE RELOAD. A NEW SUREFORM 45 STAPLER WAS THEN OPENED ALONG WITH A NEW SUREFORM 45 BLACK RELOAD FROM THE SAME LOT AS THE PRIOR FIRE. THE SAME ISSUE OCCURRED AGAIN. A NEW BLACK RELOAD WAS THEN USED A DIFFERENT LOT WITH THE SECOND SUREFORM 45 STAPLER, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO FURTHER COMPLICATIONS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25411232 ↗
• InjuryJun 5, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TRANSTHORACIC ESOPHAGECTOMY PROCEDURE, THE SUREFORM 45 BLACK RELOAD PRODUCED A TISSUE PUSHOUT EVENT TWICE ON STOMACH TISSUE. THE FIRST TISSUE PUSHOUT EVENT OCCURRED WITH THE FIRST SUREFORM 45 STAPLER INSTRUMENT, WHICH HAD MULTIPLE PRIOR SUCCESSFUL RELOAD FIRINGS. WHILE ATTEMPTING TO FIRE A BLACK RELOAD ON STOMACH TISSUE, THE TISSUE WAS PUSHED OUT ALONG WITH THE STAPLES OUT OF THE JAWS OF THE RELOAD. A NEW SUREFORM 45 STAPLER WAS THEN OPENED ALONG WITH A NEW SUREFORM 45 BLACK RELOAD FROM THE SAME LOT AS THE PRIOR FIRE. THE SAME ISSUE OCCURRED AGAIN. A NEW BLACK RELOAD WAS THEN USED A DIFFERENT LOT WITH THE SECOND SUREFORM 45 STAPLER, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO FURTHER COMPLICATIONS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25410999 ↗
• MalfunctionJan 20, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, CUSTOMER FIRED THE STAPLER, HOWEVER IT STOPPED MIDWAY AND A RED ALERT APPEARED INSTRUCTING TO REMOVE IT. AFTER SEPARATING IT FROM THE ROBOT, THE CUSTOMER TRIED TO REMOVE THE CARTRIDGE, BUT IT COULDN'T BE REMOVED FROM THE STAPLER HANDLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE FOLLOWED UP WITH THE CUSTOMER AND RECEIVED ADDITIONAL INFORMATION: ISSUE INVOLVED A PARTIAL FIRE. A RED ALERT APPEARED INSTRUCTING TO REMOVE IT. A BLACK RELOAD WAS BEING USED. A BACK UP WAS USED TO RESOLVE THE ISSUE. NO BLEEDING OBSERVED. NO TISSUE REMOVAL, NO OBSTRUCTIONS.

  Patient problems: Insufficient Information

  MAUDE report 24125219 ↗
• MalfunctionDec 22, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER INSTRUMENT MISFIRED WHILE THE SURGEON WAS USING IT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23870332 ↗
• MalfunctionDec 19, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER INSTRUMENT MISFIRED WHILE THE SURGEON WAS USING IT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23856941 ↗
• InjuryDec 16, 2025Failure to Form Staple; Failure to Form Staple

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23816399 ↗
• MalfunctionNov 14, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THAT THE SUREFORM 45 STAPLER INSTRUMENT WAS INSERTED INTO THE ARM, TISSUE WAS DETECTED, AND THE SYSTEM INDICATED THAT IT WAS POSSIBLE TO FIRE THE INSTRUMENT. HALFWAY THROUGH THE FIRING, THE SYSTEM REPORTED THAT IT COULD NO LONGER PROCEED AND THAT IT WAS NECESSARY TO REPLACE IT WITH A STRONGER RELOAD. THAT ONE COULD BE FIRED. THE ISSUE WAS THAT THE SYSTEM INCORRECTLY ASSESSED THE TISSUE THICKNESS. THE PROCEDURE WAS COMPLETED WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560030 ↗
• InjuryAug 21, 2025Material Fragmentation; Material Fragmentation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860463 ↗
• InjuryMay 27, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY PROCEDURE, A PARTIAL FIRE OCCURRED INVOLVING A SUREFORM 45 STAPLER INSTRUMENT WITH A BLACK SUREFORM 45 RELOAD, AND THERE WAS SOME UNEXPECTED BLEEDING. THE PARTIAL FIRE OCCURRED DURING THE THIRD FIRING EVENT, AND THE STAPLING STOPPED MIDWAY THROUGH THE LUNG TISSUE. THE SURGEON WAS ABLE TO SAFELY OPEN THE JAWS AND REMOVED THE INSTRUMENT FROM THE TISSUE WITH NO INJURY TO THE PATIENT. THROUGHOUT THE PROCEDURE, THERE WAS A TOTAL BLOOD LOSS OF APPROXIMATELY 50 ML, WHICH WAS SLIGHTLY HIGHER THAN ANTICIPATED BUT DID NOT CONCERN THE SURGEON. TO RESOLVE THE BLEEDING, KNITTED SURGICEL (A 3RD PARTY MANUFACTURER PRODUCT) WAS APPLIED TO THE STAPLE LINE AND SUBSEQUENTLY REMOVED BEFORE THE CLOSURE OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER COMPLICATIONS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22089064 ↗
• MalfunctionFeb 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE, THERE WAS A SOUND AND THE BLACK SURE FORM 45 RELOAD STOPPED HALFWAY. THE PROCEDURE WAS CONTINUED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE STAPLER INSTRUMENT DID WORK. THE TARGET TISSUE WAS THE LUNG. THE EVENT DID NOT INVOLVE A FAILURE TO FIRE. THE EVENT DID INVOLVE A PARTIAL FIRE. THE EVENT DID NOT INVOLVE THE STAPLER JAWS OPENING/RELEASING DURING THE FIRING SEQUENCE. THE RELOAD DID NOT DEPLOY STAPLES UNEXPECTEDLY. AN ERROR MESSAGE STATING THE TISSUE WAS TOO THICK TO CONTINUE WAS GENERATED. THERE WERE NO MALFORMED OR UNFORMED STAPLES. THE RELOAD DID HAVE AN EXPOSED BLADE. THERE WERE NO MISSING STAPLES FROM THE STAPLE LINE. THERE WERE NO HOLES/GAPS FROM THE STAPLE LINE. THE RELOAD WAS NOT STUCK TO TISSUE. THERE WAS NO BLEEDING OBSERVED ON THE STAPLE LINE. THERE WAS NO UNPLANNED TISSUE REMOVAL DUE TO THE STAPLER FIRING FAILURE. THE SURGEON USED ANOTHER BLACK RELOAD AND COMPLETED STAPLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21429029 ↗
• 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20459132 ↗
• 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 20459105 ↗
• MalfunctionSep 19, 2024Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE BLADE OF THE CURVED-TIP SUREFORM 45 STAPLER INSTRUMENT WAS EXPOSED WHEN THE CUSTOMER PHYSICALLY OPENED THE INSTRUMENT'S TIPS. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CUSTOMER TO REPLACE THE INSTRUMENT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS FOUND. THE INSTRUMENT INVOLVED A PARTIAL FIRE WITH THE "TISSUE TOO THICK TO CONTINUE" ERROR MESSAGE, AND THE FIRE SEQUENCE WAS INTERRUPTED. THE SURGEON FIRED OVER AN EXISTING STAPLE LINE. THE SURGEON DID NOT USE BUTTRESS MATERIAL AND DID NOT EXPERIENCE ANY CLAMPING ISSUES PRIOR TO FIRING THE SUREFORM 45 BLACK RELOAD. THE STAPLING ISSUE DID NOT RESULT IN MALFORMED/UNFORMED STAPLES, STAPLES MISSING, OR HOLES/GAPS OBSERVED WITHIN THE STAPLE LINE. THE CUSTOMER USED ANOTHER CURVED-TIP SUREFORM 45 STAPLER INSTRUMENT TO CUT THE TISSUE. THE AFFECTED CURVED-TIP SUREFORM 45 STAPLER INSTRUMENT WAS DISCARDED AS IT WAS USED ON AN INFECTIOUS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20263829 ↗
• MalfunctionMar 26, 2024Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE STAPLER SUREFORM 45 WAS OBSERVED TO HAVE STOPPED WORKING HALFWAY THROUGH THE PROCESS. 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: THERE WAS NO REPORT OF FRAGMENTS FALLING FROM THE DEVICE WHILE USED WITHIN A PATIENT. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETENTION OF FOREIGN MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18976551 ↗
• MalfunctionMar 24, 2024Failure to Form Staple; Failure to Form Staple

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966451 ↗
• MalfunctionNov 20, 2023

  DURING ROBOTIC THORACIC SURGICAL PROCEDURE, ROBOTIC STAPLING DEVICE DID NOT FIRE COMPLETELY. OUTERMOST ROW OF STAPLES WAS STILL IN THE STAPLE LOAD AFTER STAPLER FIRED RESULTING IN SMALL AMOUNT OF BLEEDING AT STAPLE LINE. NO ERROR MESSAGE GENERATED BY DA VINCI SYSTEM WHEN STAPLER FIRED. NEW STAPLE LOAD OPENED AND INSERTED INTO SAME STAPLE GUN. WHEN SURGEON ATTEMPTED TO USE STAPLER, SYSTEM RESPONDED THAT THERE WAS TOO MUCH TISSUE BETWEEN THE JAWS OF THE STAPLER. SURGEON REPOSITIONED STAPLER. SAME ERROR MESSAGE RECEIVED. STAPLER REMOVED FROM SERVICE. NEW STAPLER WITH NEW LOAD OPENED AND USED WITHOUT INCIDENT. EVENT REPORTED TO INTUITIVE REP. REFERENCE REPORTS: MW5148325, MW5148327.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18181419 ↗
• MalfunctionNov 20, 2023

  DURING ROBOTIC THORACIC SURGICAL PROCEDURE, ROBOTIC STAPLING DEVICE DID NOT FIRE COMPLETELY. OUTERMOST ROW OF STAPLES WAS STILL IN THE STAPLE LOAD AFTER STAPLER FIRED RESULTING IN SMALL AMOUNT OF BLEEDING AT STAPLE LINE. NO ERROR MESSAGE GENERATED BY DA VINCI SYSTEM WHEN STAPLER FIRED. NEW STAPLE LOAD OPENED AND INSERTED INTO SAME STAPLE GUN. WHEN SURGEON ATTEMPTED TO USE STAPLER, SYSTEM RESPONDED THAT THERE WAS TOO MUCH TISSUE BETWEEN THE JAWS OF THE STAPLER. SURGEON REPOSITIONED STAPLER. SAME ERROR MESSAGE RECEIVED. STAPLER REMOVED FROM SERVICE. NEW STAPLER WITH NEW LOAD OPENED AND USED WITHOUT INCIDENT. EVENT REPORTED TO INTUITIVE REP. REFERENCE REPORTS: MW5148326, MW5148327.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18181405 ↗
• MalfunctionNov 17, 2023

  DURING ROBOTIC THORACIC SURGICAL PROCEDURE, ROBOTIC STAPLING DEVICE DID NOT FIRE COMPLETELY. OUTERMOST ROW OF STAPLES WAS STILL IN THE STAPLE LOAD AFTER STAPLER FIRED RESULTING IN SMALL AMOUNT OF BLEEDING AT STAPLE LINE. NO ERROR MESSAGES GENERATED BY DA VINCI SYSTEM WHEN STAPLER FIRED. NEW STAPLE LOAD OPENED AND INSERTED INTO SAME STAPLE GUN. WHEN SURGEON ATTEMPTED TO USE STAPLER, SYSTEM RESPONDED THAT THERE WAS TOO MUCH TISSUE BETWEEN THE JAWS OF THE STAPLER. SURGEON REPOSITIONED STAPLER. SAME ERROR MESSAGE RECEIVED. STAPLER REMOVED FROM SERVICE. NEW STAPLER WITH NEW LOAD OPENED AND USED WITHOUT INCIDENT. EVENT REPORTED TO INTUITIVE REP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18174839 ↗
• InjuryNov 15, 2023Unintended Ejection; Unintended Ejection

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, WHEN FIRING THE SUREFORM 45 STAPLER THE ROBOT TOLD SURGEON TO UNCLAMP OR FORCE FIRE WITH GREEN AND BLACK LOADS ATTEMPTED ON A COLON. THE BLADE WAS EXPOSED ON REMOVAL AND REPLACED WITH ANOTHER STAPLER. THAT STAPLER EXPERIENCED THE SAME ISSUE. UNFIRED STAPLER LOADS LEFT IN PATIENT (SURGEON REMOVED). THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON WAS ABLE TO RETRIEVE ALL THE LOOSE UNFIRED STAPLES FROM THE PATIENT. THE TARGET TISSUE WAS THE RECTUM. THIS EVENT OCCURRED TWICE. INITIALLY THE FIRST STAPLER DID WORK. SURGEON NEEDED TO DO MULTIPLE FIRES DUE TO TISSUE THICKNESS. THEN AFTER THE THIRD OR FOURTH FIRE WITH A GREEN RELOAD, THE STAPLER GRASPED AND COMPRESSED BUT HALFWAY THROUGH THE FIRE THE STAPLER FEEDBACK SAID IT COULD NOT CONTINUE ANY FURTHER AND THAT THE STAPLER NEEDED TO BE REMOVED. UNFORMED STAPLES NOTED IN TISSUE. GOT ANOTHER STAPLER WITH BLACK LOAD BUT ERROR HAPPENED AGAIN, STAPLER WOULD NOT MAKE IT ACROSS, AND ROBOT WOULD NOT ALLOW IT. STAPLES

  Patient problems: Foreign Body In Patient

  MAUDE report 18141204 ↗
• MalfunctionNov 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM IN A RESEARCH AND DEVELOPMENT LAB, THE SUREFORM 45 BLACK RELOAD LEFT BEHIND TWO PIECES OF WHAT WAS PRESUMED TO BE YELLOW PUSHER MATERIAL ON THE STAPLE LINE. THIS WAS DURING AN EXCISED ANIMAL TISSUE LAB AND NO PATIENT INJURY OCCURRED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE RELOAD WAS DISCARDED. THIS WAS AN INTERNAL R&D LAB, AND THE PARTICULATE WAS OBSERVED BY CLINICAL DEVELOPMENT ENGINEERS, INCLUDING THE INITIAL REPORTER, PERFORMING THE LAB. FROM THEIR PERSPECTIVE, THERE WERE NO ABNORMAL CIRCUMSTANCES AROUND THIS FIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18137440 ↗
• MalfunctionNov 14, 2023Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE SURGEON WAS UNABLE TO COMPLETE THE STAPLE FIRE. THE SURGEON TAPPED THE BLUE PEDAL TO UNCLAMP THEN REMOVED THE STAPLER. THERE WAS A ¿WARNING BLADE MAY BE EXPOSED¿ MESSAGE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133603 ↗
• MalfunctionSep 8, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE BLADE OF THE SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT INSTALLED WITH A BLACK RELOAD WAS NOT ABLE TO CUT THE TISSUE. THE CUSTOMER USED THE THIRD-PARTY STAPLER TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE STAPLING ISSUE DID NOT RESULT TO EITHER MALFORMED OR UNFORMED STAPLES. STAPLES WERE COMPLETELY FIRED AND NO STAPLES WERE MISSING FROM THE STAPLE LINE. MOREVOER, NO HOLES/GAPS WERE OBSERVED WITHIN THE STAPLE LINE. THE RELOAD WAS NOT STUCK TO THE TISSUE. AFTER OBSERVING THE EXPOSED BLADE, INSTRUMENT WAS REMOVED SAFELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17715350 ↗
• MalfunctionJul 5, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INTUITIVE SURGICAL, INC. (ISI) RECEIVED A STAPLER RELOAD AS A RETURN. THERE WAS NO ALLEGED MALFUNCTION REPORTED AGAINST THIS ACCESSORY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ONLY ISSUE INVOLVED WITH THE CASE ON 3/20/2023 WOULD HAVE BEEN THE STAPLER ENGAGEMENT ISSUE. THERE WAS NO ISSUE WITH A RELOAD THE DAY OF THAT PROCEDURE. THE CLINICAL SALES REP (CSR) CONFIRMED WITH THE HOSPITAL THEY DO NOT RECALL THE REASONING FOR RETURNING THE RELOAD WITH THE STAPLER. THERE HAS BEEN NO MENTION OF STAPLER RELOAD MALFUNCTION OCCURRING TO THE REP WHERE A PIECE WENT MISSING.

  Patient problems: Insufficient Information

  MAUDE report 17256426 ↗
• InjuryJun 8, 2023Failure to Cut; Failure to Fire; Failure to Cut; Failure to Fire

  IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS A STAPLING ISSUE WHEN STAPLING THE ESOPHAGUS. ONCE THE BLADE GOT CLOSE TO THE "ENT," IT DID NOT RETRACT AND IT DID NOT FIRE ALL THE WAY AND THERE WERE LOOSE STAPLES EVERYWHERE AND THE DA VINCI SCISSORS WERE USED TO CUT THE ESOPHAGUS. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE, A SUREFORM 45 STAPLER INSTRUMENT ALLEGEDLY MISFIRED. THE TARGET TISSUE THE ESOPHAGUS. THE SURGEON HAD PERFORMED THE LAPAROSCOPIC PORTION OF THE PROCEDURE PRIOR TO THE DA VINCI-ASSISTED PORTION OF THE PROCEDURE. DURING THE DA VINCI-ASSISTED PROCEDURE, THE SURGEON USED TWO STAPLER INSTRUMENTS; AN ENDO GI8 LAPAROSCOPIC (LAP) STAPLER AND A SUREFORM 45 STAPLER. THE SURGEON USED SIX BLACK RELOADS AND ONE WHITE RELOAD. THE SUREFORM 45 STAPLER INSTRUMENT HAD SUCCESSFULLY FUNCTIONED THROUGHOUT THE PROCEDURE. THERE WERE SEVEN SUCCESSFUL FIRES. AS THE SURGEON WAS ON THE LAST STAPLE FIRING OF THE PROCEDURE, IT FAILED. THE SURGEON SAID THAT HE, FIRED THE SUREFORM 45 STAPLER THREE TIMES OVER THE PART OF

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17093924 ↗
• MalfunctionMay 13, 2023Break; Retraction Problem; Break; Retraction Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A BLADE WAS EXPOSED ON THE STAPLER RELOAD AFTER FIRING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16927421 ↗