SureForm 48360BRecalls & reported problems

Summary

The FDA's MAUDE database contains 136 adverse event reports that list this exact device (DI 00886874113837), received between Jul 21, 2020 and Sep 29, 2026 — classified as 92 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (41 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 136 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Failure to Form Staple; Firing Problem

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

  MAUDE report 50941351 ↗
• MalfunctionAug 27, 2026No Apparent Adverse Event

  The SureForm 60 Blue Reload accessory was an incidental return with no allegation made against this product. No known impact or patient consequence was reported.

  Patient problems: Insufficient Information

  MAUDE report 50486951 ↗
• MalfunctionJun 8, 2026Break

  IT WAS REPORTED THAT BLUE STAPLER RELOAD WAS RETURNED AS UNKNOWN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 25437080 ↗
• InjuryMay 29, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TRANSTHORACIC ESOPHAGECTOMY CHEST ANASTOMOSIS SURGICAL PROCEDURE, A SUREFORM 60 STAPLER WITH A BLUE RELOAD MISFIRED AND HAD A MISALIGNED STAPLE LINE. NO FRAGMENT FELL INTO THE PATIENT. IT IS UNKNOWN IF ANY INTERVENTION WAS REQUIRED TO ADDRESS THE MISALIGNED STAPLE LINE. THE PROCEDURE WAS COMPLETED WITH A DELAY OF LESS THAN 15 MINUTES. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25330707 ↗
• MalfunctionMay 21, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER INSTRUMENT DID NOT SEAL WHEN IT WAS SUPPOSED TO. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25246829 ↗
• MalfunctionApr 2, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THE SUREFORM 60 STAPLER INSTRUMENT MISFIRED. THE PROCEDURE WAS COMPLETED AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24770330 ↗
• InjuryMar 9, 2026Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED ROUX-EN-Y PROCEDURE, A SUREFORM 60 STAPLER INSTRUMENT FIRED A SUREFORM 60 BLUE RELOAD ON THE STOMACH, BUT DID NOT APPLY STAPLES AND THE STOMACH TISSUE WAS CUT OPEN. IT WAS REPORTED THAT THE STAPLER WORKED BEFORE AND AFTER THIS EVENT WITHOUT ISSUES. THE INDICATION FOR THE PROCEDURE WAS WEIGHT REGAIN IN MORBID OBESITY (OBESITY GRADE III). THE COMPLICATION OCCURRED DURING RESIZING OF THE GASTRIC POUCH, WHILE FIRING THE FOURTH STAPLER RELOAD OF THE PROCEDURE. THE AFFECTED STAPLE LINE RESULTED IN ABOUT 200ML OF BLOOD LOSS. THE SURGEON SUTURED THE STAPLE LINE WITH STRATAFIX TO RESOLVE THE COMPLICATION AND CONTINUE THE PROCEDURE. NO ADDITIONAL TISSUE WAS TAKEN DUE TO THIS EVENT. THIS EVENT RESULTED IN A DELAY, INSTAR-OPERATIVE GASTROSCOPY, AND EXTENDED INPATIENT MONITORING. THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS AND THEIR TREATMENT PLAN WAS NOT CHANGED DUE TO THIS EVENT. THE PATIENT WAS REPORTED TO BE DOING WELL. THE SURGEON WAS NOT ABLE TO STATE WHAT CAUSED THIS EVENT, IT WAS ADDED THAT THERE WAS NO ERROR MESSAGE OR NOTIFICATION FROM THE DA VINCI SYSTEM WHEN THIS EVENT OCCURRED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24546544 ↗
• MalfunctionMar 4, 2026Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROCEDURE, THE SUREFORM 60 STAPLER INSTRUMENT HAD FIRED TWICE BUT WOULD NOT INITIALIZE THE THIRD FIRE. THE CUSTOMER CHANGED THE THIRD FIRE OUT TO MAKE SURE IT WAS NOT THE STAPLE LOAD. PROCEDURE WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507973 ↗
• MalfunctionFeb 18, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL GASTRECTOMY SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER COULD NOT BE USED EVEN AFTER TRYING 2 RELOADS. A THIRD RELOAD WAS USED AND A BLADE FELL OUT. THE USER WAS COMPLETING THE PROCEDURE AS PLANNED 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: THERE WAS NO DAMAGE TO THE OTHER TWO RELOADS. THERE WAS NO INSTRUMENT COLLISION DURING THE PROCEDURE. THERE WAS NO FRAGMENT FALL INTO THE PATIENT AND NO INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24374310 ↗
• InjuryFeb 2, 2026Firing Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24239355 ↗
• InjuryJan 5, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS ROUY EN-Y SURGICAL PROCEDURE, WHILE STAPLING, THE SURGEON SAW A BLUE PLASTIC PIECE ON THE STAPLING LINE. HE TOOK IT OUT AND SAW A BROKEN PIECE FROM THE STAPLER RELOAD. THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960233 ↗
• InjuryOct 28, 2025Material Fragmentation; Material Fragmentation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401649 ↗
• InjuryOct 23, 2025Failure to Form Staple; Failure to Fire; Detachment of Device or Device Component; Failure to Form Staple; Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BARIATRIC SURGERY PROCEDURE, THE FIRING SEQUENCE OF A BLUE SUREFORM 60 RELOAD WITH A SUREFORM 60 STAPLER INSTRUMENT WAS INTERRUPTED FOR ADDITIONAL COMPRESSION, CAUSING STOMACH TISSUE TO BE PUSHED AND DRAGGED. THE TISSUE WAS NOT PROPERLY STAPLED OR CUT. THE STAPLES WERE MALFORMED. THIS NECESSITATED TWO ADDITIONAL ROUNDS OF STAPLING. ADDITIONALLY, STAPLES WERE NOTED TO HAVE FALLEN INSIDE THE PATIENT BUT WERE RETRIEVED. IT IS UNCLEAR IF THE STAPLING ISSUE INVOLVED ONE OR TWO BLUE SUREFORM 60 RELOADS. THE SUREFORM 60 STAPLER INSTRUMENT WITH A BLUE SUREFORM 60 RELOAD WAS INSPECTED PRIOR TO USE WITH NO REPORTED DAMAGE. THE SUREFORM 60 STAPLER INSTRUMENT WAS NOTED TO HAVE WORKED APPROPRIATELY DURING THE FIRST ATTEMPT. THE PATIENT'S STOMACH TISSUE WAS NOT CALCIFIED, OR EXPOSED TO ANY RADIATION OR CHEMOTHERAPY PRIOR TO THE PROCEDURE. THERE WAS NO TISSUE TENSION AND NO TISSUE BUNCHING. THE STAPLING ISSUE RESULTED IN POORLY FORMED STAPLES. THE STAPLER RELOAD DID NOT HAVE AN EXPOSED BLADE. THERE WERE NO HOLES OR GAPS OBSERVED WITHIN THE STAPLE LINE. THE STAPLER RELOAD WAS NOT STUCK TO THE TISSUE. WHEN THE EVENT OCCURRED, THE CUSTOMER ENCOUNTERED

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23375818 ↗
• InjurySep 10, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT AFTER THE COMPLETION OF A DA VINCI-ASSISTED DISTAL GASTRECTOMY PROCEDURE, A SUREFORM 60 BLUE RELOAD STAPLE LINE HAD SEPARATED ON THE LESSER CURVE OF THE STOMACH. THE SURGEON REPORTED THERE WERE NO INTRA-OPERATIVE COMPLICATIONS WITH THIS STAPLE LINE, NOR ANY ERRORS WITH THIS FIRE. THE SURGEON STATED THE STAPLE LINE APPEARED IN GOOD CONDITION DURING THE PROCEDURE. POST-OPERATIVELY, THE PATIENT EXPERIENCED STAPLE LINE FAILURE AT THE GASTRIC CLOSURE, PERITONITIS, INTRA-ABDOMINAL SEPSIS, AND A REOPERATION. THE PATIENT RECEIVED A REOPERATION AND GASTRIC CLOSURE VIA OPEN SURGERY ON POST-OPERATIVE DAY FIVE. DURING THE REOPERATION, A 1.5 CM DEHISCENCE OF THE BLUE RELOAD STAPLE LINE WAS OBSERVED ON THE LESSER CURVE OF THE STOMACH ALONG WITH PERITONITIS. THE REST OF THE STAPLE LINE AND OTHER ANASTOMOSES WERE OBSERVED TO BE INTACT AND FINE. THE SURGEON REPORTED THAT THE PATIENT IS SEPTIC AND CRITICALLY ILL IN THE INTENSIVE CARE UNIT (ICU). THE SURGEON REPORTED THE SEPSIS IS LIFE THREATENING. THE SURGEON SAID BASED ON THEIR OBSERVATIONS AND KNOWLEDGE ON THIS EVENT, THE CAUSE OF THIS COMPLICATION WAS A STAPLE LINE FAILURE ON THICK, OBSTRUCTED STOMACH TISSUE.

  Patient problems: Failure to Anastomose; Sepsis; Unspecified Tissue Injury

  MAUDE report 23014669 ↗
• InjuryAug 29, 2025Failure to Form Staple; Failure to Form Staple

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

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

  MAUDE report 22926810 ↗
• InjuryAug 26, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS (ROUX-EN-Y) SURGICAL PROCEDURE, FABRIC WAS PUSHED WHEN A BLUE SUREFORM 60 RELOAD WAS FIRED WITH A SUREFORM 60 STAPLER INSTRUMENT. AS A RESULT, A PARTIAL STAPLE FIRE OCCURRED. THIS ISSUE OCCURRED WITH TWO BLUE SUREFORM 60 RELOADS FROM THE SAME BATCH. NO FRAGMENTS FELL INSIDE THE PATIENT. THE ISSUE CAUSED A DELAY OF LESS THAN 15 MINUTES. IT IS UNCLEAR IF ANY TISSUE WAS DAMAGED DUE TO THE CUSTOMER REPORTED ISSUE AND IF ANY MEDICAL/SURGICAL INTERVENTION WAS RENDERED.

  Patient problems: Insufficient Information

  MAUDE report 22900652 ↗
• InjuryAug 26, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS (ROUX-EN-Y) SURGICAL PROCEDURE, FABRIC WAS PUSHED WHEN A BLUE SUREFORM 60 RELOAD WAS FIRED WITH A SUREFORM 60 STAPLER INSTRUMENT. AS A RESULT, A PARTIAL STAPLE FIRE OCCURRED. THIS ISSUE OCCURRED WITH TWO BLUE SUREFORM 60 RELOADS FROM THE SAME BATCH. NO FRAGMENTS FELL INSIDE THE PATIENT. THE ISSUE CAUSED A DELAY OF LESS THAN 15 MINUTES. IT IS UNCLEAR IF ANY TISSUE WAS DAMAGED DUE TO THE CUSTOMER REPORTED ISSUE AND IF ANY MEDICAL/SURGICAL INTERVENTION WAS RENDERED.

  Patient problems: Insufficient Information

  MAUDE report 22900502 ↗
• InjuryJul 28, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TRANSHIATAL ESOPHAGECTOMY (NON-TRANSTHORACIC) PROCEDURE, THE STAPLES FAILED TO FULLY RELEASE FROM A BLUE SUREFORM 60 RELOAD, RESULTING IN AN INCOMPLETE STAPLE LINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22629370 ↗
• MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE STAPLES FELL OUT OF THE BEFORE THE SURGEON COULD FIRE. A NEW RELOAD WAS LOADED. NO FRAGMENT FELL INTO THE PATIENT. THE USER COMPLETED THE PROCEDURE AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22392079 ↗
• MalfunctionJun 27, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED FUNDOPLICATION SURGICAL PROCEDURE, THE SYSTEM PRESENTED A "TISSUE WAS TOO THICK" MESSAGE WHILE USING SUREFORM60 STAPLER INSTRUMENT. IT WAS NOTED THAT DURING FIRING SEQUENCE, THE INSTRUMENT HAD A BLADE STICKING OUT IN THE MIDDLE. CUSTOMER REPLACED THE INSTRUMENT AND PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346900 ↗
• InjuryJun 5, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED GENERAL SURGERY PROCEDURE, THE STAPLES FROM A BLUE SUREFORM 60 RELOAD DID NOT CLOSE ALL THE WAY AND STAPLES FELL INTO THE SURGICAL SITE. THE PROCEDURE WAS BEING COMPLETED AS PLANNED.

  Patient problems: Foreign Body In Patient; Insufficient Information; Unspecified Tissue Injury

  MAUDE report 22149225 ↗
• MalfunctionMay 15, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BLADE FAILED TO RETURN AFTER SUREFORM 60 STAPLER INSTRUMENT WAS USED. THE RELOAD COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031484 ↗
• InjuryMar 20, 2025Firing Problem; Firing Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21658359 ↗
• MalfunctionFeb 20, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT THE SUREFORM 60 STAPLER MISFIRED.

  Patient problems: Insufficient Information

  MAUDE report 21429154 ↗
• MalfunctionFeb 18, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED THE SURE FORM 60 STAPLER INSTRUMENT MISFIRED ON THE 3RD USE. SHARP METAL WAS STICKING OUT ON THE MIDDLE OF THE STAPLER RELOAD. THE RELOAD WAS STUCK AND COULD NOT BE TAKEN OUT OF THE STAPLER. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21405591 ↗