SureForm 48345BRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00886874117088), received between Nov 22, 2021 and Aug 11, 2026 — classified as 13 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Firing Problem” (7 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Material Fragmentation

  It was reported that during a da Vinci-assisted surgical procedure, the SureForm 45 Blue reload was found to be damaged. After the procedure, fragments consistent with the reported damage were discovered in a saline bottle used for post-procedure cleaning by the central sterile processing department. A backup da Vinci reload was used to complete the procedure. The procedure was completed as planned with no reported patient injury. Intuitive Surgical, Inc. (ISI) contacted the customer and obtained the following information: There was no damage/no patient impact was reported. (The fragment was discovered during the procedure and cross-checked against the cartridge.) The stapler was used as-is, and the operation was completed. As a precaution, all used reload units have been sent to you.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50207162 ↗
• InjuryMay 15, 2026Firing Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED DA-VINCI ASSISTED SURGICAL PROCEDURE, AN INCOMPLETE STAPLE LINE WAS OBSERVED WHEN THREE SUREFORM 45 BLUE RELOADS WERE FIRED WITH SUREFORM 45 STAPLER INSTRUMENT. AFTER EACH STAPLER RELOAD WAS FIRED, ONLY ONE SIDE OF THE STAPLE LINE HAD STAPLES, LEAVING THE INTESTINAL LUMEN OPEN. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND SHOWED NO ABNORMALITIES. THE STAPLER FIRES INVOLVED WITH THE REPORTED EVENT WERE THE FIRST, SECOND, AND THIRD. AT THE TIME THE STAPLING ISSUES OCCURRED, THE SURGEON WAS WORKING ON THE INTESTINES AND "SETTLING THE RECTUM." THERE WAS NO TISSUE TENSION OR TISSUE BUNCHING. THE STAPLER INSTRUMENT FIRED WITHOUT PROBLEMS OR INTERRUPTIONS. NO ERROR MESSAGES WERE GENERATED WHEN THE STAPLING ISSUE OCCURRED. THE SURGEON DID NOT ENCOUNTER ANY OBSTRUCTIONS SUCH AS CLIPS, STAPLES, OR OTHER HARD MATERIAL BETWEEN THE INSTRUMENT JAWS. THE SURGEON DID NOT FIRE OVER AN EXISTING STAPLE LINE. THE SURGEON DID NOT EXPERIENCE ANY CLAMPING ISSUES PRIOR TO FIRING THE STAPLER RELOAD. NO BLEEDING WAS OBSERVED ON THE STAPLE LINE DUE TO THE STAPLER ISSUE. THE PROCEDURE WAS COMPLETED BY SUTURING THE SEAM OR STAPLE LINE BY HAND. THE ISSUE CAUSED A DELA

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25189674 ↗
• InjuryMay 15, 2026Firing Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED DA-VINCI ASSISTED SURGICAL PROCEDURE, AN INCOMPLETE STAPLE LINE WAS OBSERVED WHEN THREE SUREFORM 45 BLUE RELOADS WERE FIRED WITH SUREFORM 45 STAPLER INSTRUMENT. AFTER EACH STAPLER RELOAD WAS FIRED, ONLY ONE SIDE OF THE STAPLE LINE HAD STAPLES, LEAVING THE INTESTINAL LUMEN OPEN. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND SHOWED NO ABNORMALITIES. THE STAPLER FIRES INVOLVED WITH THE REPORTED EVENT WERE THE FIRST, SECOND, AND THIRD. AT THE TIME THE STAPLING ISSUES OCCURRED, THE SURGEON WAS WORKING ON THE INTESTINES AND "SETTLING THE RECTUM." THERE WAS NO TISSUE TENSION OR TISSUE BUNCHING. THE STAPLER INSTRUMENT FIRED WITHOUT PROBLEMS OR INTERRUPTIONS. NO ERROR MESSAGES WERE GENERATED WHEN THE STAPLING ISSUE OCCURRED. THE SURGEON DID NOT ENCOUNTER ANY OBSTRUCTIONS SUCH AS CLIPS, STAPLES, OR OTHER HARD MATERIAL BETWEEN THE INSTRUMENT JAWS. THE SURGEON DID NOT FIRE OVER AN EXISTING STAPLE LINE. THE SURGEON DID NOT EXPERIENCE ANY CLAMPING ISSUES PRIOR TO FIRING THE STAPLER RELOAD. NO BLEEDING WAS OBSERVED ON THE STAPLE LINE DUE TO THE STAPLER ISSUE. THE PROCEDURE WAS COMPLETED BY SUTURING THE SEAM OR STAPLE LINE BY HAND. THE ISSUE CAUSED A DELA

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25189121 ↗
• InjuryJul 8, 2025Material Fragmentation; Firing Problem; Material Fragmentation; Firing Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 22437746 ↗
• MalfunctionMay 21, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TRANSTHORACIC CHEST ANASTOMOSIS ESOPHAGECTOMY PROCEDURE, UNFORMED STAPLES RESULTED AFTER FIRING A SUREFORM 45 STAPLER INSTRUMENT WITH A BLUE RELOAD ACCESSORY. AN INSPECTION OF THE INSTRUMENT REVEALED NO DAMAGE OR ABNORMALITIES. AT THE TIME OF THE ISSUE, THE SURGEON WAS CONSTRUCTING A CONDUIT USING STOMACH TISSUE TO RECONSTRUCT THE ESOPHAGUS. THE CLINICAL SALES REPRESENTATIVE (CSR) SUGGESTED THAT THE PROBLEM MAY HAVE RESULTED FROM CROSSING STAPLE LINES; HOWEVER, THE SURGEON DID NOT CONFIRM THIS DURING DISCUSSIONS WITH THE CSR. TO RESOLVE THE ISSUE A BACKUP STAPLER INSTRUMENT WAS UTILIZED, BUT IT ALSO RESULTED IN UNFORMED STAPLES. SUBSEQUENTLY, THE SURGEON OPTED TO USE A THIRD-PARTY STAPLER INSTRUMENT TO COMPLETE THE STAPLING, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER COMPLICATIONS. THERE WAS NO BLEEDING OR INJURY TO THE PATIENT AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061317 ↗
• MalfunctionMay 21, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TRANSTHORACIC CHEST ANASTOMOSIS ESOPHAGECTOMY PROCEDURE, UNFORMED STAPLES RESULTED AFTER FIRING A SUREFORM 45 STAPLER INSTRUMENT WITH A BLUE RELOAD ACCESSORY. AN INSPECTION OF THE INSTRUMENT REVEALED NO DAMAGE OR ABNORMALITIES. AT THE TIME OF THE ISSUE, THE SURGEON WAS CONSTRUCTING A CONDUIT USING STOMACH TISSUE TO RECONSTRUCT THE ESOPHAGUS. THE CLINICAL SALES REPRESENTATIVE (CSR) SUGGESTED THAT THE PROBLEM MAY HAVE RESULTED FROM CROSSING STAPLE LINES; HOWEVER, THE SURGEON DID NOT CONFIRM THIS DURING DISCUSSIONS WITH THE CSR. TO RESOLVE THE ISSUE A BACKUP STAPLER INSTRUMENT WAS UTILIZED, BUT IT ALSO RESULTED IN UNFORMED STAPLES. SUBSEQUENTLY, THE SURGEON OPTED TO USE A THIRD-PARTY STAPLER INSTRUMENT TO COMPLETE THE STAPLING, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER COMPLICATIONS. THERE WAS NO BLEEDING OR INJURY TO THE PATIENT AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061126 ↗
• InjuryFeb 19, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOBECTOMY PROCEDURE, THE PROXIMAL END OF THE BLUE RELOAD WAS MISSING THE CARTRIDGE ROOT PART. A FRAGMENT FELL INSIDE THE PATIENT DURING BRONCHIAL DISSECTION, AND THE ASSISTANT USED FORCEPS TO RETRIEVE IT FROM THE BODY. THE DA VINCI ENDOSCOPE WAS USED TO CHECK INSIDE THE ANATOMY AND CONFIRM ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. NO POST-OPERATIVE TESTS LIKE AN X-RAY WERE PERFORMED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409923 ↗
• InjuryDec 4, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS (ROUX-EN-Y) PROCEDURE, WHILE FIRING A BLUE SUREFORM 45 RELOAD WITH A SUREFORM 45 STAPLER INSTRUMENT, THE CUSTOMER OBSERVED TISSUE BEING PUSHED AND NOT PROPERLY STAPLED OR CUT. THE CUSTOMER ALSO IDENTIFIED MALFORMED STAPLES. THE SURGEON WAS CREATING THE GASTRIC POUCH AND THE STAPLER HAD A LONG PAUSE DURING CLAMPING. WHEN THE STAPLES WERE DEPLOYED, THERE WAS A TISSUE PUSH AND MALFORMED STAPLES. NO ALARMS OR ERRORS WERE DISPLAYED BY THE SYSTEM. THE TEAM USED A BACKUP SUREFORM 45 STAPLER WITH BLUE RELOAD; HOWEVER, THE SAME ISSUE OCCURRED WITH THIS FIRING. THIS LED TO A TISSUE TEAR ON THE OPERATIVE SITE/TARGET AREA. A THIRD SUREFORM 45 STAPLER WITH BLUE RELOAD WAS INSTALLED AND THE SURGEON WAS ABLE TO PROCEED WITH THE CASE. THE SURGEON HAD TO CREATE ANOTHER STAPLE LINE RESULTING IN A SMALLER GASTRIC POUCH. THERE WAS SOME BLEEDING, THE ESTIMATED BLOOD LOSS IS UNKNOWN. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20845306 ↗
• MalfunctionSep 6, 2024Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER INSTRUMENT INSTALLED WITH A BLUE RELOAD WAS UNABLE TO FIRE. 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 INSTRUMENT WAS INSPECTED AND THERE WAS NO DAMAGE. THE INSTRUMENT WOULD NOT FIRE THE RELOAD. IT WAS RESEATED; HOWEVER, THE ISSUE PERSISTED. THE SURGEON DID NOT ENCOUNTER ANY OBSTRUCTIONS SUCH AS CLIPS, STAPLES, OR OTHER HARD MATERIAL BETWEEN THE INSTRUMENT JAWS. THE SURGEON DID NOT FIRE OVER AN EXISTING STAPLE LINE. NO BUTTRESS MATERIAL WAS USED. THERE WAS NO BLEEDING OBSERVED DUE TO THE STAPLING EVENT. THERE WAS NO UNPLANNED TISSUE REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20163239 ↗
• MalfunctionMar 28, 2024Break; Break

  IT WAS REPORTED THAT DURING OF A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE, THE SUREFORM STAPLER 45 INSTRUMENT INSTALLED WITH A BLUE RELOAD WAS OBSERVED TO HAVE ERRORS DURING SETUP AND A CRACK IN THE MIDDLE OF THE RELOAD WAS IDENTIFIED. THE PROCEDURE WAS CONTINUED USING A BACKUP WITH NO REPORTED INJURY. NO FRAGMENT FELL INSIDE THE PATIENT. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO ISSUE WITH THE BLUE RELOAD DURING INSPECTION, BEFORE USE. AN ERROR MESSAGE ¿TISSUE TOO THICK TO CONTINUE¿ APPEARED DURING STAPLE FIRE. THE BLADE WAS EXPOSED AND STUCK IN THE PLASTIC PART OF THE RELOAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991748 ↗
• MalfunctionNov 13, 2023Material Integrity Problem; Material Integrity Problem

  INTUITIVE SURGICAL, INC. (ISI) RECEIVED A BLUE SUREFORM 45 RELOAD WITH NO ALLEGATIONS. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18125934 ↗
• InjuryOct 12, 2023Firing Problem; Firing Problem

  ON (B)(6) 2023, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT WITH MDR REPORT #MW5145176 STATING "THREE (3) INCIDENTS OF A SUREFORM 45 STAPLER MALFUNCTIONING AND MISFIRING AND IN THE LAST 4 MONTHS. LOT #T10221003 REF(B)(4), EXP: 10/31/2024. REFERENCE REPORTS: MW5145175, MW5145177."

  Patient problems: Insufficient Information

  MAUDE report 17927340 ↗
• InjuryOct 12, 2023Misfire; Misfire

  ON 14-SEP-2023, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT WITH MDR REPORT #MW5145177 STATING: "THREE (3) INCIDENTS OF A SUREFORM 45 STAPLER INSTRUMENT MALFUNCTIONING AND MISFIRING AND IN THE LAST 4 MONTHS. LOT #T10221003 REF (B)(4), EXP: 10/31/2024. REFERENCE REPORTS: MW5145175, MW5145176."

  Patient problems: Insufficient Information

  MAUDE report 17922790 ↗
• MalfunctionAug 24, 2023Failure to Form Staple; Failure to Form Staple

  THE STAPLER SUREFORM RELOAD 45 WAS AN INCIDENTAL RETURN WITH A STAPLER SUREFORM 45 WHICH WAS REPORTED TO HAVE FIRE/PARTIAL FIRE FAILURE. NO ALLEGATION WAS MADE AGAINST THIS PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 17609480 ↗
• InjuryAug 2, 2023Material Separation; Failure to Cut; Material Separation; Failure to Cut

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE SUREFORM 45 BLUE RELOAD BLADE STOPPED HALFWAY, AND THE RECTAL TISSUE COULD NOT BE CUT. A SYSTEM MESSAGE ¿TISSUE TOO THICK TO CONTINUE¿ APPEARED. 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 BLEEDING OR UNPLANNED TISSUE REMOVAL DUE TO THE STAPLER ISSUE. THE ISSUE WAS RESOLVED BY USING A THIRD-PARTY STAPLER. THERE WAS NO PATIENT¿S IMPACT DUE TO THE ISSUE. THE INSTRUMENT WILL NOT BE RETURNED SINCE IT WAS DISCARDED. THE RELOAD WILL BE RETURNED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17446517 ↗
• InjuryJun 30, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY PROCEDURE, WHILE STAPLING ACROSS THE BRONCHUS WITH A SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT LOADED WITH A GREEN SUREFORM 45 CURVED-TIP STAPLER RELOAD, THERE WAS A PARTIAL FIRE, AND THE END OF THE STAPLE LINE WAS NOT SEALED. THE STAPLES FROM THE END OF THE RELOAD DID NOT DEPLOY. THERE WAS AN UNSPECIFIED AMOUNT OF BLEEDING DUE TO THE GAP IN THE STAPLE LINE. THE SURGEON SWITCHED TO A BLUE SUREFORM 45 CURVED-TIP STAPLER RELOAD, AND THE SAME ISSUE OCCURRED. THE SURGEON SWITCHED TO A LAPAROSCOPIC STAPLER AND CONTINUED THE STAPLE LINE, WITH NO FURTHER ISSUES. THE STAPLER HAD FIRED AN UNSPECIFIED NUMBER OF LOADS SUCCESSFULLY, PRIOR TO THIS ISSUE. THE SURGEON USED AN INTRAOPERATIVE BRONCHOSCOPE TO CHECK THE STAPLE LINE. BOTH THE GREEN AND BLUE RELOADS HAD EXPOSED BLADES. PER THE REPORTER, THE SURGEON DOWNSIZED TO A BLUE RELOAD AFTER USING THE GREEN RELOAD, DUE TO THE THICKNESS OF THE TARGET TISSUE AT THE END OF THE INTENDED STAPLE LINE. THE TARGET TISSUE WAS REPORTEDLY IN A NORMAL STATE, AND THE PATIENT WAS REPORTEDLY IN A NORMAL CONDITION FOLLOWING THE PROCEDURE. INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17236361 ↗
• MalfunctionApr 6, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER INSTRUMENT INSTALLED WITH BLUE RELOAD WAS USED AND INSPECTION AFTER STAPLING IDENTIFIED UNFORMED STAPLES (NOT B-SHAPED). THE CUSTOMER STATED THAT NO SYSTEM MESSAGE I.E. TISSUE TOO THICK TO FIRE WAS DISPLAYED, AND THE RESECTION WAS COMPLETED WITH "NOMINAL" FIRE. THE ISSUE OCCURRED TWICE ON TWO BLUE RELOADS. THE FIRST OCCURRENCE HAPPENED BETWEEN THE UPPER AND THE MIDDLE LOBE, AND THE SECOND OCCURRENCE HAPPENED BETWEEN THE UPPER AND LOWER LOBE. AFTER OBSERVING THE ISSUE, ANOTHER RELOAD (WHITE RELOAD) WAS INSTALLED INTO THE SAME INSTRUMENT TO CONTINUE WITH THE SURGICAL TASK. USER CONFIRMED THAT NO ISSUE WAS EXPERIENCED WITH THE WHITE 45 RELOAD WHEN USED ON THE VESSEL. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE STAPLER AND RELOADS WERE INSPECTED PRIOR TO USE WITH NO ISSUE. THE REPORTED EVENT OCCURRED DURING STAPLING ON THE UPPER MIDDLE LOBE AND BETWEEN THE UPPER AND LOWER LOBE. THE CUSTOMER STATED THAT THE TISSUE WAS NOT CALCIFIED AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16692220 ↗
• MalfunctionApr 6, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER INSTRUMENT INSTALLED WITH BLUE RELOAD WAS USED AND INSPECTION AFTER STAPLING IDENTIFIED UNFORMED STAPLES (NOT B-SHAPED). THE CUSTOMER STATED THAT NO SYSTEM MESSAGE I.E. TISSUE TOO THICK TO FIRE WAS DISPLAYED, AND THE RESECTION WAS COMPLETED WITH "NOMINAL" FIRE. THE ISSUE OCCURRED TWICE ON TWO BLUE RELOADS. THE FIRST OCCURRENCE HAPPENED BETWEEN THE UPPER AND THE MIDDLE LOBE, AND THE SECOND OCCURRENCE HAPPENED BETWEEN THE UPPER AND LOWER LOBE. AFTER OBSERVING THE ISSUE, ANOTHER RELOAD (WHITE RELOAD) WAS INSTALLED INTO THE SAME INSTRUMENT TO CONTINUE WITH THE SURGICAL TASK. USER CONFIRMED THAT NO ISSUE WAS EXPERIENCED WITH THE WHITE 45 RELOAD WHEN USED ON THE VESSEL. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE STAPLER AND RELOADS WERE INSPECTED PRIOR TO USE WITH NO ISSUE. THE REPORTED EVENT OCCURRED DURING STAPLING ON THE UPPER MIDDLE LOBE AND BETWEEN THE UPPER AND LOWER LOBE. THE CUSTOMER STATED THAT THE TISSUE WAS NOT CALCIFIED AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691759 ↗
• InjuryFeb 2, 2023Misfire; Misfire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL GASTRECTOMY PROCEDURE, AN ERROR OCCURRED WHILE USING THE SUREFORM 45 STAPLER INSTRUMENT WITH A BLUE SUREFORM 45 RELOAD. THE ISSUE OCCURRED WITH THE THIRD STAPLER FIRE, DURING THE GASTRIC RECONSTRUCTION WHEN PERFORMING THE CLOSURE OF THE COMMON FORAMEN OF THE STOMACH. IT WAS OBSERVED THAT THE TISSUE BEING CLAMPED WAS COMING UP TOWARD THE DISTAL END OF THE STAPLER. THERE WAS NO TENSION BUT BUNCHING OF THE TISSUE WAS OBSERVED DURING STAPLING. THE STAPLER JAWS DID NOT INVOLVE THE OPENING OR RELEASING DURING THE FIRING SEQUENCE. THE STAPLING ISSUE DID NOT GENERATE ANY ERROR MESSAGES. THE SURGEON DID NOT KNOW WHETHER HE HAD FIRED OVER AN EXISTING STAPLE LINE. BLEEDING WAS OBSERVED FROM THE CLOSED COMMON FORAMEN AREA. THE AMOUNT OF BLEEDING WAS VERY SMALL IN QUANTITY. NO BLOOD TRANSFUSION WAS ADMINISTERED. THE SURGEON PERFORMED ADDITIONAL SUTURING TO CONTROL THE BLEEDING. A THIRD-PARTY STAPLER WAS USED TO CUT THE TARGET TISSUE SUBSEQUENTLY. THE INSTRUMENT AND RELOAD HAD BEEN INSPECTED PRIOR TO USE WITH NO DAMAGE OR ABNORMALITIES FOUND. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

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

  MAUDE report 16284873 ↗
• InjuryJul 8, 2022Material Fragmentation; No Device Output; Material Fragmentation; No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, A "MISSING OR USED RELOAD" MESSAGE WAS DISPLAYED WITH A NEW RELOAD. THE CUSTOMER RESEATED THE STERILE ADAPTER AND RELOAD BUT THE RELOAD WAS NOT RECOGNIZED. THE CUSTOMER ATTACHED A DIFFERENT RELOAD AND IT WAS RECOGNIZED. THE REST OF THE RELOADS WERE ABLE TO BE USED WITH NO PROBLEM AT ALL. THE CUSTOMER NOTED A STAPLE FELL INSIDE THE PATIENT'S BODY IMMEDIATELY AFTER THE RELOAD WAS INSTALLED. THE CUSTOMER WAS ABLE TO RETRIEVE THE STAPLE. THE RELOAD COULD NOT BE USED AFTER. A BACKUP RELOAD WAS INSTALLED TO CONTINUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH A DOCTOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ONLY ONE STAPLE FELL INSIDE THE PATIENT. AN ASSISTANT WAS ABLE TO RETRIEVE THE STAPLE FROM THE PATIENT. THERE WAS NO POST-OPERATIVE TESTS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE ISSUE OCCURRED DURING THE THIRD FIRING. THE PRODUCT WAS INSPECTED PRIOR TO USE AND NO ABNORMALITY WAS FOUND. THE STAPLE FELL INSIDE THE PATIENT WHEN THE STAPLER AND RELOAD WAS BEING REMOVED. THERE WAS NO ISSUE WITH THE FUNCTIONALITY OF THE INSTRUME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14961228 ↗
• InjuryApr 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PNEUMONECTOMY LOBECTOMY SURGICAL PROCEDURE, AFTER CUTTING BETWEEN THE LEAVES, A U-SHAPE STAPLE FROM THE SUREFORM 45 RELOAD FELL NEAR THE CUTTING LINE BEFORE B-SHAPE FORMATION. THE CUSTOMER IMMEDIATELY RETRIEVED THE STAPLE FROM THE PATIENT. THE CUSTOMER WAS USING MULTIPLE BLUE RELOADS AND COULDN'T IDENTIFY WHEN IT FELL. THE CUSTOMER USED A BACKUP RELOAD TO CONTINUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE STAPLE FELL ON THE PATIENT'S LUNG. THE SURGEON GRASPED THE STAPLE AND REMOVED IT FROM THE PATIENT. ALL STAPLES WERE RETRIEVED AND CONFIRMED. NO POST-OPERATIVE TESTS LIKE X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE INSTRUMENT WAS VISUALLY INSPECTED PRIOR TO USE AND NO DAMAGE WAS FOUND. THE STAPLE WAS FOUND AFTER THE COMPLETION OF A FIRE. IT WAS UNKNOWN IF THE INSTRUMENT COLLIDED WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE MULTIPLE TIMES PRIOR TO THE BREAKAGE. NO BLEEDING OCCURRED. THE P

  Patient problems: Insufficient Information

  MAUDE report 14198013 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SIGMOID COLECTOMY THAT THE PATIENT RETURNED TO THE HOSPITAL (TWO DAYS POST-OPERATIVE) WITH ABDOMINAL PAIN. THE CUSTOMER REPORTED THAT "A PIN SIZE HOLE" WAS DISCOVERED IN ONE OF THE STAPLE LINES. THE SURGEON WAS REPORTEDLY QUESTIONING THIS STAPLE LINE AND BELIEVED IT MAY HAVE CONTRIBUTED TO THE EVENT. THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY TO CLOSE THE HOLE. ON 16-NOV-2021, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SURGEON OF THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE PATIENT HAD A LARGE POLYP ON THE CECUM. THIS PROCEDURE WAS A RIGHT COLECTOMY WITH INTRACORPOREAL ANASTOMOSIS. THE STAPLE LINE THAT LEAKED WAS WHERE AN ISOPERISTALTIC SIDE TO SIDE ANASTOMOSIS WAS DONE WITH A BLUE STAPLER RELOAD. FIREFLY MODE WAS USED TO ASSESS VASCULATURE AND REPORTEDLY WORKED WELL. THE PATIENT DID WELL POST-OPERATIVELY FOR ABOUT 48 HOURS, BUT DEVELOPED ACUTE ABDOMINAL PAIN AND RETURNED TO THE HOSPITAL. A PHYSICAL EXAM WAS PERFORMED AND THE SITE BECAME SUSPICIOUS OF AN ANASTOMOTIC LEAK. THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) FOR AN EXPLORATORY OPERATION. DURING THE SURGERY, A 2MM LEAK WAS NOTICED AT

  Patient problems: Failure to Anastomose

  MAUDE report 12858430 ↗