SureForm 48360GRecalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00886874113844), received between Aug 11, 2020 and Aug 3, 2026 — classified as 48 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (33 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 69 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Failure to Form Staple

  It was reported that during a da Vinci-assisted pulmonary lobectomy procedure, lung parenchyma tissue was pushed out of the jaws of a SureForm 60 Stapler instrument equipped with a SureForm 60 Green Reload. After unclamping, the tissue appeared torn and the staple line was poorly formed. A malformed staple was also observed lodged in the blade track or groove of the stapler reload. The surgeon suspected the stapler reload may have become obstructed by a staple after firing across an existing staple line. No bleeding occurred; however, additional tissue excision was required. The issue was resolved by switching to a SureForm 60 Black Reload, and the procedure was completed robotically.The patient had no postoperative complications, there is no concern for long-term complications related to the event, and the patient has been discharged.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50122706 ↗
• MalfunctionApr 18, 2026Positioning Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 60 GREEN RELOAD WAS JAMMED AND WAS UNABLE TO BE REMOVED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919105 ↗
• MalfunctionApr 11, 2026Firing Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24849326 ↗
• MalfunctionFeb 2, 2026Positioning Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE SURGICAL TECH WAS UNABLE TO REMOVE STAPLER RELOAD CARTRIDGE FROM THE SUREFORM 60 STAPLER AFTER USING. SEVERAL TEAM MEMBERS ATTEMPTED TO REMOVE UNSUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS ARE AVAILABLE REGARDING THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24230869 ↗
• InjuryDec 30, 2025Failure to Form Staple; Firing Problem; Failure to Form Staple; Firing Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 23919561 ↗
• InjuryDec 30, 2025Failure to Form Staple; Firing Problem; Failure to Form Staple; Firing Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 23919552 ↗
• MalfunctionDec 22, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL GASTRECTOMY SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER INSTRUMENT WAS INSERTED INSIDE THE BODY CAVITY FOR TRANSECTION, BUT IT FAILED TO OPERATE AND WAS UNUSABLE. BOTH THE STAPLER INSTRUMENT AND THE RELOAD WERE REPLACED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871657 ↗
• InjuryNov 20, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED TRANSTHORACIC ESOPHAGECTOMY WITH CHEST ANASTOMOSIS PROCEDURE, THE PATIENT EXPERIENCED A STAPLE LINE LEAK LESS THAN 24 HOURS POSTOPERATIVELY. THE LEAK ORIGINATED FROM THE MIDSECTION OF THE LINEAR STAPLE LINE ON THE GASTRIC TUBE, WHERE A GREEN SUREFORM 60 RELOAD HAD BEEN UTILIZED. WHILE THE PROXIMAL AND DISTAL ENDS OF THE STAPLE LINE DISPLAYED APPROPRIATE B-SHAPED STAPLE FORMATION, THE CENTRAL SEGMENT EXHIBITED INADEQUATE STAPLE FORMATION. THIS DEFECT RESULTED IN LEAKAGE OF BILE AND GASTRIC SECRETIONS INTO THE RIGHT THORACIC CAVITY. INITIAL REVISION WAS ATTEMPTED VIA THORACOSCOPY BUT HAD TO BE CONVERTED TO OPEN THORACOTOMY DUE TO POOR CARDIOPULMONARY STATUS. THE LEAK WAS REPAIRED USING SUTURE, AND A LAVAGE OF THE THORACIC CAVITY WAS PERFORMED. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS. ENDOSCOPIC IMAGES WERE REVIEWED, AND DOCUMENTED THE STAPLE LINE INSUFFICIENCY, SHOWING BILE SURROUNDING THE WOUND (NOT NECROSIS). INTRAOPERATIVELY, THE SURGEON OBSERVED NO TECHNICAL ISSUES; THE STAPLE LINE APPEARED INTACT, AND S

  Patient problems: Biliary Leak; Unspecified Tissue Injury

  MAUDE report 23609502 ↗
• InjuryNov 7, 2025Firing Problem; Firing Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23497176 ↗
• InjuryJul 24, 2025Failure to Form Staple; Firing Problem; Failure to Form Staple; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ABDOMINOTHORACIC ESOPHAGECTOMY WITH INTRATHORACIC ANASTOMOSIS PROCEDURE, A PARTIAL FIRE OCCURRED WHILE USING A SUREFORM 60 STAPLER INSTRUMENT WITH A GREEN SUREFORM 60 RELOAD, RESULTING IN AN INCOMPLETE STAPLE LINE. THE STAPLER INSTRUMENT WAS FIRED FOLLOWING A PREVIOUS STAPLE LINE; HOWEVER, THE SURGEON DID NOT FIRE OVER THE EXISTING STAPLE LINE. DURING THE FIRING SEQUENCE, STOMACH TISSUE SLIPPED OUT OF THE STAPLER JAWS AND WAS PUSHED FORWARD WITHOUT BEING PROPERLY STAPLED OR CUT. AN ERROR MESSAGE WAS DISPLAYED STATING: ¿STAPLES FAILED. RELEASE AND REMOVE THE STAPLER USING THE BLUE PEDAL. WARNING: BLADE MAY BE EXPOSED.¿ UPON INSPECTION, THE STAPLES WERE MALFORMED AND PARTIALLY FORMED, WITH SEVERAL SCATTERED WITHIN THE BODY. NO MAJOR BLEEDING WAS REPORTED, THOUGH AN ESTIMATED BLOOD LOSS WAS NOT PROVIDED. TO ADDRESS THE ISSUE, A FEW MILLIMETERS OF ADDITIONAL TISSUE WERE EXCISED USING A MONOPOLAR CURVED SCISSORS INSTRUMENT, AND THE LOOSE STAPLES WERE RETRIEVED. THE AFFECTED TISSUE WAS THEN APPROXIMATED AND SUTURED CLOSED. A BACKUP GREEN SUREFORM 60 RELOAD WAS SUBSEQUENTLY FIRED; HOWEVER, A SIMILAR ISSUE RECURRED. DURING THE FIRING SEQUENCE

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

  MAUDE report 22592406 ↗
• MalfunctionJun 16, 2025No Apparent Adverse Event; No Apparent Adverse Event

  INTUITIVE SURGICAL, INC. (ISI) RECEIVED A SUREFORM RELOAD AS AN RMA. THERE WAS NO ALLEGED MALFUNCTION REPORTED AGAINST THE PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 22216507 ↗
• InjuryMay 5, 2025Failure to Form Staple; Failure to Form Staple

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Tissue Breakdown

  MAUDE report 21959474 ↗
• InjuryMar 26, 2025Firing Problem; Firing Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21700688 ↗
• InjuryMar 26, 2025Firing Problem; Firing Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21699382 ↗
• MalfunctionMar 13, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED THEY ATTEMPTED FIRE MULTIPLE TIMES HOWEVER THE TISSUE WAS TOO THICK, SO FROM BLUE TO GREEN FILLING. TISSUE FURTHER SKELETONIZED. WHEN LIGHT WAS GREEN THEY FIRED, HOWEVER AFTER A WHILE. IT STOPPED FIRING. CUSTOMER HAD TO STOP DURING OPERATION AND BLADE STICKS OUT. THE PROCEDURE WAS COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 21599769 ↗
• InjuryOct 17, 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 20468731 ↗
• 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 20458500 ↗
• InjurySep 18, 2024Failure to Form Staple; Failure to Form Staple

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20247988 ↗
• MalfunctionSep 11, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE SUREFROM 60 STAPLER INSTRUMENT JAWS DID NOT OPEN WELL. THE INSTRUMENT JAWS WERE STIFF WHEN OPERATING FROM THE SURGEON SIDE CONSOLE (SSC). WHEN THE CUSTOMER USED THE GREEN RELOAD TO STAPLE THE PATIENT¿S TISSUE, A MESSAGE ¿TISSUE TOO THICK¿ APPEARED. THE CUSTOMER REPLACED THE GREEN RELOAD WITH THE BLACK RELOAD, BUT THE SAME MESSAGE WAS GENERATED. THE CUSTOMER REPLACED WITH A NEW STAPLER INSTRUMENT, BUT THE ISSUE PERSISTED. AFTER THIS, THE CUSTOMER CLAMPED HALF OF THE TISSUE AND ATTEMPTED TO FIRE; HOWEVER, A MESSAGE ¿TISSUE TOO THICK¿ REAPPEARED AFTER A PARTIAL FIRE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE STAPLER INSTRUMENTS AND RELOADS WERE INSPECTED PRIOR TO USE WITH NO ISSUE. THE REPORTED EVENT WAS INVOLVED DURING THE FIRST FIRE OF THE SECOND STAPLER INSTRUMENT. PARTIAL FIRE ISSUE OCCURRED WHEN THE CUSTOMER WAS STAPLING THE STOMACH TISSUE. THE STAPLING ISSUE DID NOT RESULT ANY OF THE FOLLOWINGS: MALFORMED/UNFORMED STAPLES, EXPOSED BLADE, MISSING STAPLE LINE, HOLES/GAP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20196571 ↗
• MalfunctionSep 10, 2024Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TRANSCERVICAL NON-TRANSTHORACIC ESOPHAGECTOMY SURGICAL PROCEDURE, THE CUSTOMER NOTED THAT THE SUREFORM 60 STAPLER INSTRUMENT COMPRESSED A LOT WITH THE 2ND SUREFORM 60 GREEN RELOAD BUT FINALLY TRIGGERED PARTIALLY. AFTER ABOUT HALF OF THE RELOAD LENGTH, AN ERROR SOUNDED AND THE INSTRUMENT DID NOT RELEASE COMPLETELY. THE BLADE REMAINED EXTENDED AND THE RELOAD COULD NOT BE CHANGED AS A RESULT. THE CUSTOMER REPLACED THE SUREFORM 60 STAPLER INSTRUMENT WITH A BACK-UP INSTRUMENT OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20183860 ↗
• MalfunctionSep 4, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER INSTRUMENT MISFIRED WHILE USING THE GREEN SUREFORM 60 RELOAD AND THE BLADE WAS EXPOSED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20137167 ↗
• InjuryJun 12, 2024Firing Problem; Firing Problem

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19518510 ↗
• InjuryJun 11, 2024Firing Problem; Firing Problem

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19515859 ↗
• MalfunctionJun 6, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE 2ND PHASE OF A DA VINCI-ASSISTED ABDOMINOPERINEAL RESECTION SURGICAL PROCEDURE, THE STAPLE LINE WAS INCOMPLETE WITH A SUREFORM 60 GREEN RELOAD. BEFORE DEPLOYMENT, THE CARTRIDGE PASSED THE INSPECTION AND NOTHING NON-STANDARD WAS NOTICED. NO ISSUE WAS OBSERVED DURING THE FIRST 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 REPORTER CONFIRMED THAT RECTUM AMPUTATION WAS BEING PERFORMED AT THE TIME OF EVENT. THE TISSUE WAS NOT CALCIFIED AND WAS NOT EXPOSED TO ANY RADIATION OR CHEMOTHERAPY PRIOR TO THE PROCEDURE. THERE WAS NO TISSUE TENSION NEITHER ANY TISSUE BUNCHING. THE EVENT DID NOT INVOLVE A FAILURE TO FIRE AND DID NOT INVOLVE A PARTIAL FIRE. THE EVENT DID NOT INVOLVE TISSUE BEING PUSHED FORWARD/DRAGGED DURING THE FIRING PROCESS NEITHER INVOLVE THE STAPLER JAWS OPENING/RELEASING DURING THE FIRING SEQUENCE. THE EVENT DID NOT INVOLVE RELOAD DEPLOYING STAPLES UNEXPECTEDLY. THE STAPLING ISSUE RESULTED IN MALFORMED / UNFORMED STAPLES AND ALSO STAPLES MISSING FROM THE STAPLE LINE. THERE WERE HOLES/GAPS OBSERVED WITHIN THE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19480201 ↗
• MalfunctionMay 15, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, AN ISSUE OCCURRED WITH A GREEN RELOAD. THE STAPLING BLADE ON THE SUREFORM 60 STAPLER DID NOT STAY STRAIGHT WHEN CUTTING AND STARTED TO CUT THE PLASTIC. THE SURGEON USED ANOTHER RELOAD TO RECUT THE SMALL INTESTINE AND MAKE SURE THE STAPLING WAS PERFECT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE EVENT DATE IS 04/23/2024. THE STAPLER WORKED PROPERLY BEFORE THE INCIDENT WITH THE SAME BATCH OF STAPLER.

  Patient problems: Insufficient Information

  MAUDE report 19317430 ↗