EndoWrist;daVinci Si 420230Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00886874111680), received between Oct 11, 2020 and Aug 19, 2025 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. Jul 1, 2022Class IIOpen, Classified

   Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.

   Z-1459-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22845469 ↗
• MalfunctionMar 19, 2025Material Fragmentation; Material Fragmentation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21647582 ↗
• MalfunctionFeb 13, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE LARGE HEM-O-LOK CLIP APPLIER HAD DIFFICULTY HANDLING THE CLIP. THE CUSTOMER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21379381 ↗
• MalfunctionJun 24, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT HAD A POOR CLIP CLOSURE. THE PROCEDURE WAS COMPLETED WITH A DELAY OF LESS THAN 15 MINUTES AND NO PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE SURGEON COULD NOT APPLY THE CLIP WHEN THE INSTRUMENT WAS IN THE PATIENT. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195935 ↗
• MalfunctionMay 27, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PROCEDURE, THE JAWS OF THE CLIP APPLIER SPUN AROUND AND WOULD NOT CLIP. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015818 ↗
• MalfunctionMay 13, 2023Material Frayed; Difficult to Open or Close; Material Frayed; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL HYSTERECTOMY - MALIGNANT SURGICAL PROCEDURE, THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WIRE WAS BROKEN. A BACKUP INSTRUMENT WAS USED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16926731 ↗
• MalfunctionMay 13, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT HAD A LOOSE CABLE/CABLE OFF TRACK. 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 INSPECTED PRIOR TO USE. THE COLOR OF THE BROKEN/LOOSE CABLE WAS BLACK AND NO DAMAGED WAS FOUND TO THE CONDUCTOR WIRE INSULATION. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER TOOL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16926722 ↗
• MalfunctionJul 3, 2022Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT HAD NON-INTUITIVE MOTION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ISSUE WAS FOUND. THE MOVEMENT OF THE INSTRUMENT WAS NOT SMOOTH AND UNINTUITIVELY. THE ISSUE WAS SOLVED USING BACK UP INSTRUMENT. EACH OCCURRENCE WAS WITH THE SAME INSTRUMENT ON THE SAME SYSTEM ARM. THE DRAPE WAS NOT EXCHANGED AT ANY TIME DURING THE PROCEDURE. THE DRAPE WAS ALREADY DISPOSED. NO PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE AVAILABLE FOR ISI REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14898703 ↗
• MalfunctionJun 30, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING THREE SEPARATE DA VINCI -ASSISTED LOW ANTERIOR RESECTION PROCEDURES ON (B)(6) 2021, (B)(6) 2021 AND (B)(6) 2021, THERE WAS A NON-INTUITIVE MOTION ISSUE WITH THE LARGE CLIP APPLIER. THIS REPORT WILL COVER THE REPORTED INCIDENT ON (B)(6) 2021. FOR THE PROCEDURE ON (B)(6) 2021, BLEEDING OF 750 ML WAS OBSERVED FROM THE INFERIOR MESENTERIC ARTERY (IMA). THE PATIENT DID NOT RECEIVE A BLOOD TRANSFUSION AND IT IS UNKNOWN IF ANY SURGICAL/MEDICAL INTERVENTION WAS REQUIRED. ACCORDING TO THE SURGEON, THERE WAS UNCONTROLLED MOVEMENT DURING APPLICATION OF THE CLIP WHEN CLOSING THE JAWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14876240 ↗
• InjuryMay 30, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THERE WAS A NON-INTUITIVE MOTION ISSUE WITH THE LARGE CLIP APPLIER INSTRUMENT WHEN CLOSING OF THE GRIPS WAS ATTEMPTED. THE MOVEMENT WAS DESCRIBED AS ¿UNCONTROLLED.¿ IT WAS NOTED THAT THE PATIENT SUSTAINED BLEEDING FROM THE INFERIOR MESENTERIC ARTERY (IMA), BUT IT WAS NOT SEVERE. THE VOLUME OF BLOOD LOSS WAS REPORTED TO BE LESS THAN 750 ML AND THE PATIENT WAS NOT TRANSFUSED WITH BLOOD. THE PROCEDURE WAS COMPLETED WITH THE DA VINCI SURGICAL SYSTEM. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SURGEON VIA A NURSE AT THE SITE: THERE WAS NO BLEEDING IN THE PATIENT FOR THE PROCEDURE AND NO LOOSE CABLE SEEN ON THE INSTRUMENT. ACCORDING TO THE SURGEON, THERE WAS UNCONTROLLED MOVEMENT DURING APPLICATION OF THE CLIP WHEN CLOSING THE JAWS. THERE WAS NO LOOSE CABLE SEEN IN THE INSTRUMENT DURING APPLICATION OF THE CLIP. THE SURGEON CHECKED THAT THE CLIP WAS PROPERLY LATCHED ON AFTER APPLICATION OF THE CLIP. THE PROCEDURE WAS COMPLETED ROBOTICALLY, AND THE PROCEDURE WAS NOT PROLONGED DUE TO THE ISSUE. THERE WAS NO FRAGMENT THAT FELL INTO THE PATIENT AS WELL A

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14541361 ↗
• MalfunctionMay 26, 2022Unintended System Motion; Unintended Movement; Unintended System Motion; Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI -ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THERE WAS A NON-INTUITIVE MOTION ISSUE WITH THE LARGE CLIP APPLIER INSTRUMENT. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED PATIENT HARM, INJURY, OR ADVERSE OUTCOME. FOLLOW-UP WAS PERFORMED WITH THE SURGEON, AND ADDITIONAL INFORMATION WAS OBTAINED. THERE WAS NON-INTUITIVE MOTION WHILE APPLYING THE CLIP WITH THE LARGE CLIP APPLIER. IT WAS UNKNOWN WHETHER THE CLIP WAS PROPERLY LATCHED ON AFTER APPLICATION OF THE CLIP, BUT IT WAS NOTED THAT THE SURGEONS WERE EXPERIENCED AND WELL VERSED ON HOW TO USE THE INSTRUMENT. THE SURGEONS WERE ALSO NOT SURE THAT THE BLEEDING OCCURRED DUE TO THE NON-INTUITIVE MOTION OF THE LARGE CLIP APPLIER. THERE WAS NO LOOSE CABLE SEEN DURING APPLICATION OF THE CLIP. THERE WAS NO BLEEDING OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14520005 ↗
• MalfunctionMar 13, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE SURGEON COULD NOT ACTIVATE THE LARGE CLIP APPLIER INSTRUMENT. THE CUSTOMER REPLACED THE LARGE CLIP APPLIER 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 13752697 ↗
• MalfunctionDec 9, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRECTOMY SURGICAL PROCEDURE, THE TIPS OF LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT COULD NOT BE OPENED TO INSERT THE CLIP. A THIRD PARTY INSTRUMENT WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE ENDOWRIST LARGE CLIP APPLIER IS INTENDED TO BE USED WITH THE DA VINCI SYSTEM FOR THE APPLICATION OF LARGE WECK HEM-O-LOK POLYMER LOCKING LIGATION CLIPS FOR LIGATION OF VESSELS AND TISSUE BUNDLES RANGING IN SIZE FROM 5¿13 MM IN DIAMETER. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER FOR ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12966817 ↗
• MalfunctionJul 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LARGE-HEM-O-CLIP APPLIER WAS OBSERVED TO HAVE A YELLOW FLASHING LIGHT AND AN ERROR STATED THAT THE INSTRUMENT WAS NOT INSERTED PROPERLY. A BACKUP INSTRUMENT OF THE SAME KIND WAS USED AND THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION, BUT WAS NOT SUCCESSFUL. NO FURTHER DETAILS HAVE BEEN RECIEVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186784 ↗
• MalfunctionJun 12, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WAS NOT ATTACHING CLIPS PROPERLY. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ORIGINAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE COMPLAINT: SHE WAS TOLD THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WASN¿T ATTACHING CLIPS PROPERLY. SHE CAN¿T REMEMBER IF THE INSTRUMENT HAD A LOOSE OR BROKEN CABLE. THE SURGICAL TEAM DID NOT MENTION IF THERE WAS ANY PATIENT HARM OR IF ANY FRAGMENTS FELL INTO THE PATIENT. SHE BELIEVES NO FRAGMENTS FELL AND THAT THERE WAS NO PATIENT INJURY, BUT SINCE THAT INFORMATION WAS NOT PROVIDED, SHE STATES "UNKNOWN" TO BE SAFE. SHE DOES NOT HAVE ANY PATIENT-RELATED INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11988770 ↗
• InjuryMay 21, 2021Unintended Movement; Unintended Movement

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypovolemic Shock; Low Blood Pressure/ Hypotension

  MAUDE report 11865616 ↗
• MalfunctionOct 27, 2020Use of Device Problem; Use of Device Problem

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10744697 ↗
• MalfunctionOct 11, 2020Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED CHOLECYSTECTOMY PROCEDURE, THE LARGE CLIP APPLIER HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT THE CLIP APPLIER WAS WORKING FINE INITIALLY AND HALFWAY THROUGH THE PROCEDURE, THEY OBSERVED THAT IT HAD A LOOSE CABLE. THAT IS WHEN THEY REPLACED IT WITH ANOTHER INSTRUMENT OF THE SAME KIND TO COMPLETE THE PROCEDURE. THE INSTRUMENT WAS REPORTEDLY INSPECTED PRIOR TO USE, NO COLLISION OCCURRED INTRA-OPERATIVELY, AND NO INSTRUMENT FRAGMENT FELL INSIDE THE PATIENT. NO PATIENT INJURY WAS OBSERVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10660140 ↗