EndoWrist 470036Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00886874112236), received between Dec 6, 2020 and Mar 31, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (7 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 19, 2024Open, Classified

   Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

   Z-0852-2025 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24749108 ↗
• MalfunctionFeb 26, 2026No Apparent Adverse Event

  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 24465376 ↗
• MalfunctionFeb 25, 2026Detachment of Device or Device Component

  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 24450361 ↗
• MalfunctionFeb 23, 2026Material Frayed

  IT WAS REPORTED THAT THERE WAS A FRAYED CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24422822 ↗
• MalfunctionFeb 20, 2026Material Fragmentation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24407415 ↗
• MalfunctionNov 5, 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 23481422 ↗
• MalfunctionSep 16, 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 23068786 ↗
• MalfunctionSep 15, 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 23058743 ↗
• MalfunctionSep 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22984796 ↗
• MalfunctionAug 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929134 ↗
• MalfunctionApr 24, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM DEBAKEY FORCEPS INSTRUMENT HAD A FRAYED CABLE. NO FRAGMENTS FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21904872 ↗
• MalfunctionApr 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21756982 ↗
• MalfunctionMar 18, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CONDUCTOR WIRE (BLACK) WAS FOUND DAMAGED THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. 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 21636355 ↗
• MalfunctionNov 28, 2024Material Fragmentation; Material Fragmentation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20803725 ↗
• MalfunctionAug 15, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE DEBAKEY FORCEPS INSTRUMENT WRIST CABLE BROKE. A BACKUP INSTRUMENT OF THE SAME KIND WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT HARM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY OBSERVED. THE ISSUE OCCURRED DURING A MITRAL VALVE REPAIR. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THERE WERE NO ISSUES RELATED TO OPENING OR CLOSING THE GRIPS, LEFT AND RIGHT (YAW) MOTION OF THE GRIPS, OR UP AND DOWN (PITCH) MOTION OF THE WRIST. ONE CABLE, WHICH CONTROLS THE OPENING AND CLOSING OF THE JAWS, WAS VISIBLY PROTRUDING FROM THE DISTAL END OF THE INSTRUMENT. NO FRAGMENT FALL INSIDE THE PATIENT'S ANATOMY. NO VIDEO OR PHOTOGRAPHIC IMAGES OF THE DEVICES ARE AVAILABLE FOR ISI TO REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19988916 ↗
• MalfunctionAug 10, 2024Material Fragmentation; Material Fragmentation

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19957005 ↗
• MalfunctionMay 2, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED REVASCULARIZATION OF THE MYOCARDIUM SURGICAL PROCEDURE, THE DEBAKEY FORCEPS INSTRUMENT RELEASED A FILAMENT FROM THE STEEL CABLE AT ITS TIP JOINT, ON ITS SECOND USE, LEAVING 8 LIVES LEFT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE OR ANYTHING OUT OF THE ORDINARY WAS FOUND BEFORE THE PROCEDURE. THE SURGICAL TASK WAS COMPLETING THE SURGERY, MYOCARDIAL REVASCULARIZATION SURGERY. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL. THERE WERE NO ISSUES OPENING/CLOSING THE GRIPS, LEFT/RIGHT (YAW) MOTION, OR UP/DOWN (PITCH) MOTION. ONE CABLE WAS VISIBLY PROTRUDING FROM THE DISTAL END, A PHOTO WAS PREVIOUSLY SENT. THE CUSTOMER COULD NOT ANSWER WHICH MOTION THE PROTRUDING CABLE CONTROLS. ONE MICRO FILAMENT BROKE BUT DID NOT RELEASE FROM THE TWEEZERS. A FRAGMENT DID NOT FALL INTO THE PATIENT. THE INSTRUMENT WAS AVAILABLE FOR RETURN AND WAS ALREADY SENT LAST WEEK. AN IMAGE WAS ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19227332 ↗
• MalfunctionAug 3, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TONGUE BASE RESECTION - BENIGN SURGICAL PROCEDURE, THE DEBAKEY FORCEPS INSTRUMENT HAD A BROKEN CABLE. 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 15158037 ↗
• MalfunctionDec 6, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED RADICAL TONSILLECTOMY SURGICAL PROCEDURE, THE DEBAKEY FORCEPS JAWS WOULD NOT MOVE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10955651 ↗