EndoWrist 48445GRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00886874112823), received between Nov 13, 2021 and May 23, 2023 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (3 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 18, 2026.

Recalls naming this device

1. Apr 23, 2018Class IITerminated

   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-2381-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2023Misfire; Misfire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION PROCEDURE, THE ENDOWRIST STAPLER 45 INSTRUMENT MISFIRED WHEN A GREEN STAPLER 45 RELOAD WAS FIRED. AS A RESULT, THE SURGEON ELECTED TO CONVERT THE PROCEDURE TO OPEN SURGERY. 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: Insufficient Information

  MAUDE report 16988961 ↗
• InjuryMay 13, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THAT THE SURGEON CLAMPED THE STAPLER 45 INSTRUMENT ON TISSUE AND FIRED THE STAPLER WITHOUT DIFFICULTY. ONCE THE STAPLER WAS REMOVED FROM THE PATIENT, IT WAS NOTED THAT A SMALL PIECE OF THE STAPLER RELOAD WAS HANGING AND EMBEDDED IN THE TISSUE. THE SURGEON WAS ABLE TO CUT THE TISSUE OUT WITH THE PIECE OF THE REMAINING STAPLE LOAD AND REMOVED IT FROM THE PATIENT. PER THE STAFF TECHNICIAN (ST) THAT LOADED THE STAPLER, THERE WERE NO ISSUES PLACING THE LOAD AND IT SNAPPED INTO PLACE CORRECTLY. THE PIECE THAT BROKE OFF WAS AT THE BACK OF THE LOAD. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SITE ROBOTICS COORDINATOR AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE EVENT. THE TARGET TISSUE THAT WAS BEING STAPLED DURING THIS EVENT WAS THE DORSAL VEIN COMPLEX. A SMALL SECTION OF THE TARGET TISSUE WAS EXCISED DUE TO THE STAPLER RELOAD FRAGMENT BEING EMBEDDED IN THE TISSUE. THE SURGEON REPORTED THAT THIS EXCISION OF TISSUE DID NOT ADVERSELY AFFECT THE PROCEDURE. THE SURGEON REPORTED THAT THE RELOAD FRAGMENT WAS EMBEDDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925188 ↗
• MalfunctionMar 16, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE SUREFORM 45 STAPLER HAD AN EXPOSED BLADE. THE SUREFORM 45 GREEN RELOAD WAS RETURNED WITH THE SUREFORM STAPLER 45 INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16560387 ↗
• MalfunctionOct 14, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE STAPLER 45 INSTRUMENT AND GREEN RELOAD DID NOT FIRE ACROSS THE TISSUE. THE STAPLES WERE STILL IN THE CARTRIDGE AFTER THE SURGEON FIRED ON THE DORSAL VEIN COMPLEX. THE SURGEON USED THE SAME STAPLER 45 INSTRUMENT 2-3 TIMES WITH DIFFERENT RELOADS AND HAD THE SAME ISSUE. THE PROCEDURE WAS COMPLETED WITH THE SAME STAPLER 45 INSTRUMENT WITH NO REPORTED INJURY. ON(B)(6)2022 , INTUITIVE SURGICAL, INC. (ISI) RECEIVED USERFACILITY REPORT (B)(4) STATING: "STAPLER WITH GREEN RELOAD DIDN'T FIRE ACROSS TISSUES. STAPLERS ARE STILL IN CARTRIDGE AFTER SURGEON FIRED ON DORSAL VEIN COMPLEX, USED 2-3 TRIED WITH DIFFERENT STAPLER RELOADS, SAME ISSUE." ISI HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612042 ↗
• MalfunctionOct 14, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE STAPLER 45 INSTRUMENT AND GREEN RELOAD DID NOT FIRE ACROSS THE TISSUE. THE STAPLES WERE STILL IN THE CARTRIDGE AFTER THE SURGEON FIRED ON THE DORSAL VEIN COMPLEX. THE SURGEON USED THE SAME STAPLER 45 INSTRUMENT 2-3 TIMES WITH DIFFERENT RELOADS AND HAD THE SAME ISSUE. THE PROCEDURE WAS COMPLETED WITH THE SAME STAPLER 45 INSTRUMENT WITH NO REPORTED INJURY. ON 23-SEP-2022, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT 5000510000-2022-8038 STATING: "STAPLER WITH GREEN RELOAD DIDN'T FIRE ACROSS TISSUES. STAPLERS ARE STILL IN CARTRIDGE AFTER SURGEON FIRED ON DORSAL VEIN COMPLEX, USED 2-3 TRIED WITH DIFFERENT STAPLER RELOADS, SAME ISSUE." ISI HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612036 ↗
• InjuryJun 27, 2022Misfire; Misfire

  IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, A BRONCHIAL AIR LEAK WAS IDENTIFIED AFTER A GREEN STAPLER 45 RELOAD WAS FIRED WITH A STAPLER 45 INSTRUMENT. THE INITIAL REPORTER ALLEGED THAT THERE WAS AN INSUFFICIENT BRONCHIAL SEAL. THE SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY. ON 29-MAY-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: NO PHOTOGRAPHIC IMAGES OR VIDEO RECORDING AVAILABLE. THE SYSTEM, INSTRUMENT AND ACCESSORY WERE INSPECTED PRIOR TO USE. THERE WAS NO VISIBLE DAMAGE FOUND AT THE TIME. THE SURGEON FIRED THREE STAPLER RELOADS. IT WAS REPORTED THAT THE FIRST AND LAST FIRINGS WORKED WELL. THEREFORE, IT WAS SUSPECTED BY THE REPORTER THAT THE SECOND FIRING WAS ASSOCIATED WITH THE REPORTED AIR LEAK. THE TARGET TISSUE WAS BRONCHUS. THE TISSUE WAS NOT EXPOSED TO ANY RADIATION OR CHEMOTHERAPY PRIOR TO THE PROCEDURE. NO BUTTRESS MATERIAL WAS USED. THERE WAS NO DAMAGE TO THE TISSUE PRIOR TO THE FIRINGS. THE REPORTER INDICATED THAT IT WAS POSSIBLE THAT THERE WAS A LITTLE TENSION. NO CLAMPING ISSUES WERE EXPERIENCED BY THE SURGEON PRIOR TO FIRING THE STAPLER RELOAD.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14825496 ↗
• MalfunctionApr 2, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE. THE STAPLER 45 INSTRUMENT INSTALLED WITH A GREEN RELOAD SUCCESSFULLY FIRED THE STAPLES FOR RECTUM DISSECTION. HOWEVER; THE USER EXPERIENCED DIFFICULTY REMOVING THE INSTRUMENT OUT OF THE CANNULA. THE SURGEON STATED THAT THE INSTRUMENT RELEASE BUTTON WAS HARD, AND THE INSTRUMENT COULD NOT BE REMOVED. THE USER PERFORMED TROUBLESHOOTING BY INITIALLY STRAIGHTENING THE WRIST AND MANIPULATING THE STAPLER INSTRUMENT IN THE BODY CAVITY, BUT THE ISSUE PERSISTED. THE SYSTEM THEN DISPLAYED A PROMPT INSTRUCTING THE USER TO APPLY THE STAPLER RELEASE KIT (SRK). AFTER APPLICATION OF THE SRK, THE STAPLER INSTRUMENT WAS SUCCESSFULLY REMOVED OUT OF THE CANNULA AND THE UNIVERSAL SIDE MANIPULATOR (USM) ARM. USE OF THE INSTRUMENT WAS DISCONTINUED. A THIRD PARTY STAPLER WAS USED TO COMPLETE THE SURGICAL TASK. THE PROCEDURE WAS COMPLETED USING THE SAME DA VINCI SYSTEM WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE STAPLER WAS INSPECTED PRIOR TO USE WITH NO DAMAGE. THE SURGICAL TASK RECTUM DISSECTION WAS BEING PERFORMED WHEN THE ISSUE OCCURRED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13992376 ↗
• InjuryJan 11, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) SURGICAL PROCEDURE, THE STAPLE LINE FORMED AS EXPECTED WITH AN ENDOWRIST STAPLER 45 INSTRUMENT AND GREEN RELOAD THEN SUBSEQUENTLY THE STAPLE LINE OPENED BACK UP. IT WAS REPORTED THAT A SECOND GREEN RELOAD WAS USED AND THE SAME BEHAVIOR WAS OBSERVED AGAIN. MORE SPECIFICALLY, IT WAS REPORTED THAT THE TWO STAPLE LINES WERE FORMED AND B-SHAPE FORMATION (INTENDED FORMATION) WAS OBSERVED, BUT SLIGHTLY AFTER STAPLING WAS PERFORMED, THE STAPLE LINE OPENED BACK UP, WHICH RESULTED IN A NEED TO EXCISE ADDITIONAL COLON TISSUE THAT WAS NOT PLANNED TO BE EXCISED. THE THIRD RELOAD STAPLED AS EXPECTED/INTENDED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DA VINCI SURGICAL SYSTEM. THE INITIAL REPORTER INDICATED THAT THE PATIENT DID NOT EXPERIENCE ANY INTRA-OPERATIVE/POST-OPERATIVE COMPLICATIONS AND THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS, AND ACCESSORIES ONCE THE THIRD RELOAD FIRE WAS SUCCESSFUL. PER FOLLOW-UP WITH THE INITIAL REPORTER, THE SURGEON INDICATED THAT THIS EVENT DID NOT IMPACT THE PROCEDURE AS A WHOLE AND THAT THERE WAS NO EFFECT TO THE PATIENT¿S HEA

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13233394 ↗
• InjuryJan 11, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) SURGICAL PROCEDURE, THE STAPLE LINE FORMED AS EXPECTED WITH AN ENDOWRIST STAPLER 45 INSTRUMENT AND GREEN RELOAD, THEN SUBSEQUENTLY THE STAPLE LINE OPENED BACK UP. IT WAS REPORTED THAT A SECOND GREEN RELOAD WAS USED AND THE SAME BEHAVIOR WAS OBSERVED AGAIN (CAPTURED IN THIS REPORT). MORE SPECIFICALLY, IT WAS REPORTED THAT THE TWO STAPLE LINES WERE FORMED AND B-SHAPE FORMATION (INTENDED FORMATION) WAS OBSERVED, BUT SLIGHTLY AFTER STAPLING WAS PERFORMED, THE STAPLE LINE OPENED BACK UP, WHICH RESULTED IN A NEED TO EXCISE ADDITIONAL COLON TISSUE THAT WAS NOT PLANNED TO BE EXCISED. THE THIRD RELOAD STAPLED AS EXPECTED/INTENDED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DA VINCI SURGICAL SYSTEM. THE INITIAL REPORTER (NURSE) INDICATED THAT THE PATIENT DID NOT EXPERIENCE ANY INTRA-OPERATIVE/POST-OPERATIVE COMPLICATIONS AND THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS, AND ACCESSORIES ONCE THE THIRD RELOAD WAS SUCCESSFUL. PER FOLLOW-UP WITH THE INITIAL REPORTER, THE SURGEON INDICATED THAT THIS EVENT DID NOT IMPACT THE PROCEDURE AS A WHOLE AND THAT THERE WAS

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13233094 ↗
• InjuryNov 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR), THAT TOWARDS THE END OF A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE SURGEON WAS STAPLING THE BRONCHUS AND A TEAR OCCURRED IN THE BRONCHUS. AS A RESULT, THE PROCEDURE CONVERTED TO AN OPEN PROCEDURE. IT WAS NOTED BY THE INITIAL REPORTER THAT THE STAPLING ISSUE OCCURRED DUE TO CALCIFIED TISSUE. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION ON (B)(6) 2021. AN ENDOWRIST 45 STAPLER WAS INSTALLED AND FIRED ACROSS THE RIGHT LOWER LOBE BRONCHUS. THERE WAS AN ERROR MESSAGE STATING, "TISSUE TOO THICK TO CONTINUE. BLADE MAY BE EXPOSED.¿ THERE WAS A PARTIAL STAPLE LINE SEEN ON THE BRONCHUS. THE CSR IS UNSURE WHETHER THERE WERE ANY RETAINED STAPLES IN THE RELOAD OR IF THERE WAS A HOLE IN THE STAPLE LINE. THE ANESTHETIST THEN INFORMED THE SURGEON THAT THERE WAS AN AIR LEAK. A TUBE WAS INSERTED INTO THE PATIENT`S MOUTH AND THE AIR LEAK WERE LOCATED ADJACENT TO THE STAPLE LINE. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY IN ORDER TO FIX THE AIR LEAK. A PATCH WAS SUTURED OVER THE AIR LEAK. THERE WAS NO BLEEDING SEEN IN THE PATIENT. THE PROCEDURE WAS COMPLET

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12808152 ↗