EndoWrist 48645BRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00886874112878), received between Aug 22, 2020 and May 27, 2023 — classified as 1 death, 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Misfire” (6 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Apr 23, 2018Terminated

   Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired.

   Z-2380-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2023Misfire; Failure to Cut; Misfire; Failure to Cut

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE CUSTOMER FIRED A STAPLER 45 INSTRUMENT WITH A BLUE RELOAD AND STAPLES FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE FRAGMENT WAS RETRIEVED WITH A LAPAROSCOPIC FORCEPS. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. THE SURGEON BELIEVES THAT THERE WAS SOMETHING WRONG WITH THE RELOADS. THE ISSUE OCCURRED AT THE SECOND FIRING WHILE STAPLING THE COLON. THERE WAS NO INJURY TO THE PATIENT. THE CUSTOMER DID NOT PERFORM POST-OPERATIVE TESTS TO CHECK FOR A REMAINING FRAGMENT. THERE WAS NO COLLISION WITH ANY OTHER INSTRUMENT OR HARD MATERIAL. UPON FINAL REMOVAL, THE WRIST WAS STRAIGHTENED, AND NO RESISTANCE FELT. THE CANNULA AND INSTRUMENT WAS INSPECTED AFTER THE PROCEDURE, AND NO DAMAGE WAS NOTED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE FRAGMENT FALL INTO PATIENT WAS REFERRING TO A STAPLE

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17015648 ↗
• MalfunctionMay 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE BLUE ENDOWRIST STAPLER 45 RELOAD WAS AN INCIDENTAL RETURN. NO ALLEGATION WAS MADE AGAINST THIS PRODUCT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE OUTCOME FIELD WAS SELECTED IN ERROR. THE PROCEDURE WAS COMPLETED ROBOTICALLY, BUT THE CUSTOMER USED A LAPAROSCOPIC INSTRUMENT. THE COORDINATOR WAS NOT IN THE CASE. SHE WAS INFORMED THAT DURING A SIGMOID COLECTOMY PROCEDURE, THE SURGEON HAD ISSUES WITH TWO STAPLER 45 INSTRUMENTS. THE FIRST STAPLER FIRED SUCCESSFULLY ON COLON TISSUE BUT WOULD NOT UNCLAMP FROM THE TISSUE. THE ASSISTANT HAD TO USE THE STAPLER RELEASE KEY TO OPEN THE JAWS AND REMOVED THE STAPLER. THE CUSTOMER DOES NOT KNOW IF THE TISSUE WAS TOO THICK OR IF THERE WERE ANY OBSTRUCTION IN THE JAWS OF THE STAPLER. ONCE THE STAPLER WAS REMOVED FROM THE PATIENT, THE CUSTOMER COULD NOT REMOVE THE RELOAD FROM THE STAPLER JAWS. THE SECOND STAPLER 45 WAS USED AT THIS POINT, BUT THIS STAPLER FAILED TO INITIALIZE, AND THEY COULD NOT USE IT. THE CUSTOMER ELECTED TO USE A THIRD-PARTY STAPLER FOR THE REST OF THE CASE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY. THE CUSTOMER WILL RMA BOTH S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015526 ↗
• InjuryMay 13, 2023Misfire; Misfire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE STAPLER 45 INSTRUMENT MISFIRED WITH TWO DIFFERENT BLUE RELOADS. THE CUSTOMER NOTED AN EXPOSED BLADE ERROR MESSAGE AND STAPLES FELL INSIDE THE PATIENT. THE STAPLES WERE RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER USED A THIRD PARTY LAPAROSCOPIC STAPLER TO CONTINUE AND THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE INSTRUMENT AND ACCESSORIES WERE INSPECTED PRIOR TO USE WITH NO DAMAGE NOTED. THE PROCEDURE WAS A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE. THE REPORTED ISSUE HAPPENED DURING A SECOND FIRE ON THE BOWEL TISSUE WITH THE STAPLER 45 INSTRUMENT. THE TISSUE WAS NOT EXPOSED TO ANY RADIATION/CHEMOTHERAPY AND IT WAS NOT CALCIFIED. PRIOR TO THE STAPLER FIRE, THE SURGEON EXPERIENCED CLAMPING ISSUE AND ENCOUNTERED OBSTRUCTIONS BETWEEN THE INSTRUMENT JAWS. THE SURGEON DID NOT USE BUTTRESS MATERIAL. THE SURGEON ALSO NOTED MALFORMED STAPLES. THERE WAS NO EXCESSIVE BLEEDING OR TISSUE DAMAGE. THE OR STAFF DISCARDED ALL RELOADS THAT WERE USED DURING THE PROCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16927556 ↗
• InjuryMay 13, 2023Misfire; Misfire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE STAPLER 45 INSTRUMENT MISFIRED WITH TWO DIFFERENT BLUE RELOADS. THE CUSTOMER NOTED AN EXPOSED BLADE ERROR MESSAGE AND STAPLES FELL INSIDE THE PATIENT. THE STAPLES WERE RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER USED A THIRD PARTY LAPAROSCOPIC STAPLER TO CONTINUE AND THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE INSTRUMENT AND ACCESSORIES WERE INSPECTED PRIOR TO USE WITH NO DAMAGE NOTED. THE PROCEDURE WAS A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE. THE REPORTED ISSUE HAPPENED DURING A SECOND FIRE ON THE BOWEL TISSUE WITH THE STAPLER 45 INSTRUMENT. THE TISSUE WAS NOT EXPOSED TO ANY RADIATION/CHEMOTHERAPY AND IT WAS NOT CALCIFIED. PRIOR TO THE STAPLER FIRE, THE SURGEON EXPERIENCED CLAMPING ISSUE AND ENCOUNTERED OBSTRUCTIONS BETWEEN THE INSTRUMENT JAWS. THE SURGEON DID NOT USE BUTTRESS MATERIAL. THE SURGEON ALSO NOTED MALFORMED STAPLES. THERE WAS NO EXCESSIVE BLEEDING OR TISSUE DAMAGE. THE OR STAFF DISCARDED ALL RELOADS THAT WERE USED DURING THE PROCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16927522 ↗
• MalfunctionJan 21, 2023Retraction Problem; Failure to Form Staple; Retraction Problem; Failure to Form Staple

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16220434 ↗
• DeathJan 11, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, THE CUSTOMER UNDERWENT A REVISION SURGERY ON POST-OPERATIVE DAY (POD) #3 VIA OPEN TECHNIQUE BY THE SAME SURGEON. THE PATIENT DIED ON POD #10 DUE TO PERITONITIS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE PROCEDURE WAS PERFORMED DUE TO ADENOCARCINOMA OF THE "ASCENDING COLON T2N0MO, STAGE 2." THE PROCEDURE LASTED ABOUT 3 HOURS WITH NO INTRAOPERATIVE COMPLICATIONS, MINOR BLEEDING ABOUT 10-15 ML, AND ENDED WITH AN INTRACORPOREAL ANASTOMOSIS. THE TERMINAL ILEUM WAS DIVIDED BY AN ENDOWRIST STAPLER 45 INSTRUMENT, USING ONE BLUE STAPLER 45 RELOAD. THE TRANSVERSE COLON WAS DIVIDED BY A ENDOWRIST STAPLER 45 INSTRUMENT USING TWO BLUE RELOADS. THE ANASTOMOSIS BETWEEN THE ILEUM AND TRANSVERSE COLON WAS DONE USING ONE BLUE RELOAD. ON POD #3, THE PATIENT WAS DIAGNOSED WITH POST-OPERATIVE PERITONITIS AND AN EXPLORATORY LAPAROTOMY WAS DONE. TOTAL PERITONITIS WAS FOUND, AND THE SOURCE OF INFECTION WAS LEAKAGE FROM THE STUMP OF THE SMALL INTESTINE WITH A DIAMETER OF 3 MM, AND VITAL MUCOSA WAS SEEN. THE INTESTINAL CONTENTS LEAKED THROUGH THE STAPLES. A RESECTION OF

  Patient problems: Failure to Anastomose; Peritonitis; Sepsis

  MAUDE report 16138558 ↗
• MalfunctionJul 10, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE ENDOWRIST STAPLER 45 HAD A STAPLE STUCK TO THE JAW AFTER IT FIRED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ON 20-JUN-2022, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER STATED THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE TASK AT THE TIME WAS STAPLING. THE CUSTOMER EXPLAINED THERE WAS A STAPLE LEFT STUCK TO THE JAW AFTER IT WAS FIRED. THE CUSTOMER IS RETURNING THE INSTRUMENT TO MAKE SURE IT WASN¿T DAMAGED AS THEY DID NOT WANT TO USE THE STAPLER AGAIN IF IT WAS BENT OR DAMAGED. THE CUSTOMER STATED THE STAPLER HAD PREVIOUSLY WORKED. THERE WERE NO ERRORS/MESSAGES GENERATED WHEN THE EVENT OCCURRED. THE TARGET TISSUE WAS BOWEL. THE CUSTOMER STATED THAT THE STAPLE LINE LOOKED FINE, BUT THE SURGEON USED ANOTHER STAPLER TO COMPLETE THE PROCEDURE. THE CUSTOMER ENSURED THERE WAS NO ADVERSE EFFECT TO THE TISSUE. THE RELOAD IS NOT AVAILABLE FOR RETURN AND THERE IS NO VIDEO/IMAGES OF THE EVENT/DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14973768 ↗
• InjuryJun 26, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, DURING STAPLING/CUTTING WITH A BLUE RELOAD, THE TISSUE BUNCHED AND CREATED A TEAR IN THE BOWEL. AS A RESULT, THE BOWEL WAS SUTURED. THE PROCEDURE WAS COMPLETED AND THE PATIENT¿S STATUS WAS REPORTED TO BE STABLE. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING INFORMATION FROM THE SITE: IT WAS REPORTED THAT THE STAPLER CUT WITHOUT FIRING THE STAPLES, AND THE SURGEON SUTURED THE HOLE IN THE BOWEL. IT WAS CONFIRMED THAT THE SURGEON DID NOT USE BUTTRESS MATERIAL, AND THERE IS NO VIDEO RECORDING OR PHOTOGRAPHIC IMAGES FOR REVIEW. ON (B)(6) 2020, ISI RECEIVED USER FACILITY MEDWATCH REPORT# 4900240000-2020-8096 REGARDING THE EVENT, WHICH CONTAINED THE FOLLOWING EVENT DESCRIPTION: DA VINCI 45 STAPLER FOR GASTRIC BYPASS. DOCTOR FIRED A BLUE LOAD STAPLE AND UPON DOING SO, IT CUT THE TISSUE HOWEVER IT FAILED TO FIRE THE STAPLES LEAVING AN OPEN HOLE IN THE STOMACH.

  Patient problems: Bowel Perforation

  MAUDE report 14823619 ↗
• InjuryJun 24, 2022Misfire; Misfire

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED LOW ANTERIOR RESECTION (LAR) PROCEDURE, THE ENDOWRIST STAPLER 45 INSTRUMENT PARTIALLY FIRED A BLUE STAPLER 45 RELOAD. ACCORDING TO THE INITIAL REPORT, THE STAPLER RELOAD CUT THROUGH TISSUE. HOWEVER, IT IS UNCLEAR IF THERE WAS ANY UNAPPROXIMATED TISSUE IN RELATION TO THE STAPLING ISSUE. AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: AFTER THE STAPLING ISSUE OCCURRED, THE SURGEON SWITCHED OUT THE ENDOWRIST STAPLER 45 INSTRUMENT WITH ANOTHER ENDOWRIST STAPLER 45 INSTRUMENT AND CONTINUED WITH THE CASE ROBOTICALLY. ISI HAS ATTEMPTED REACHED OUT TO THE SURGEON TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT BUT HAS NOT YET RECEIVED A RESPONSE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14807282 ↗
• MalfunctionDec 26, 2021Misfire; Misfire

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13085607 ↗
• InjuryJun 22, 2021Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE STAPLER 45 INSTRUMENT MISFIRED AND "FIRED STAPLES ALL OVER." THE CUSTOMER NOTED THE STAPLES WERE NOT IN A LINE, AND THE SURGEON HAD TO REMOVE THE STAPLES INDIVIDUALLY. THE CUSTOMER ALSO REPORTED THERE WAS NO ADDITIONAL BLEEDING EXPERIENCED BY THE PATIENT. THE SITE REPLACED THE STAPLER 45 INSTRUMENT WITH A BACK-UP INSTRUMENT OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON WAS WORKING ON A BRONCHIAL DIVISION AT THE TIME OF THE EVENT. THE SURGEON CHOSE THE STAPLER 45 BLUE RELOAD FOR THICKER BRONCHIAL TISSUE. THE CUSTOMER REPORTED THAT THE STAPLER 45 INSTRUMENT WAS ABLE TO CLAMP DOWN WITH APPROPRIATE PRESSURE AFTER THE UNCLAMPING/CLAMPING MANEUVER. THE CUSTOMER NOTED AN ERROR OCCURRED WHEN THE SURGEON INITIATED THE FIRING. THE KNIFE STOPPED, AND A WARNING SIGNAL WAS GIVEN TO RELEASE THE STAPLER 45 INSTRUMENT. THE SYSTEM GENERATED A ¿BLADE MAY BE EXPOSED¿ ERROR MESSAGE AT THE TIME OF THE REPORTED ISSUE. THE CUSTOMER NOTED THAT THEY DID NOT SE

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12046948 ↗
• InjuryJan 11, 2021Difficult to Open or Close; Difficult to Open or Close

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11152775 ↗
• InjuryOct 5, 2020Failure to Form Staple

  DA VINCI 45 STAPLER FOR A GASTRIC BYPASS. DOCTOR FIRED A BLUE LOAD STAPLE AND UPON DOING SO, IT CUT THE TISSUE HOWEVER IT FAILED TO FIRE THE STAPLES LEAVING AN OPEN HOLE IN THE STOMACH.

  Patient problems: Failure to Anastomose; Laceration(s)

  MAUDE report 10626447 ↗
• InjuryAug 22, 2020Break; Break

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10440451 ↗