EndoWrist SP 430009Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00886874115213), received between Aug 31, 2022 and Sep 25, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (14 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Unintended Movement

  It was reported that during a da Vinci-assisted a Single Port (SP) Cadiere Forcep instrument did not move in the same direction as the surgeon¿s console hand control. 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 moved in an unintended direction. The instrument was replaced with a backup instrument.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895696 ↗
• MalfunctionJul 28, 2026Unintended System Motion

  Refer to H11 for Follow-Up information.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50063618 ↗
• MalfunctionMay 18, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, USER INFORMED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT THE MOVEMENT OF THE SINGLE PORT CADIERE FORCEPS INSTRUMENT ON THE SCREEN APPEARED TO BE ABNORMAL. AS THE CASE PROGRESSED, CREAKING WAS OBSERVED ON THE SCREEN WHEN OPENING AND CLOSING THE JAW OF THE CADIERE FORCEPS INSTRUMENT. AT THE REQUEST OF THE SURGEON, THE INSTRUMENTS WERE INSPECTED, AND IT WAS CONFIRMED THAT THE SHAFT AND JAW OF THE CADIERE FORCEPS HAD BECOME DANGLING AND DETACHED UPON INSPECTION OF THE INSTRUMENT SHEATH. THE INSTRUMENT WAS REMOVED AND REPLACED WITH A BACKUP. FOLLOWING THIS, THE USER CONTINUED AND COMPLETED THE PROCEDURE WITH NO FURTHER ISSUES. NO FRAGMENT FELL INTO THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203238 ↗
• MalfunctionMay 6, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, 6MM SP CADIERE FORCEPS INSTRUMENT ROTATED THE WRONG WAY. 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 TIP WAS GOING BACKWARDS AND WHEN THE JAWS WERE OPENED THE INSTRUMENT TIP MOVED BACKWARDS IN THE OPPOSITE DIRECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107628 ↗
• MalfunctionApr 6, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYMECTOMY SURGICAL PROCEDURE, THE 6MM CADIERE FORCEPS INSTRUMENT WORKED IN THE OPPOSITE DIRECTION AS INTENDED. LEFT WAS RIGHT AND UP WAS DOWN. THE SURGICAL TEAM TRIED TO RESEAT THE INSTRUMENT AND DRAPE REPEATEDLY. THE PROCEDURE WAS COMPLETED, AND NO INJURIES WERE REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE EVENT. THERE WAS NO INSTRUMENT-TO-INSTRUMENT OR SYSTEM ARM-TO-ARM INTERFERENCE, AND NO EXTERNAL COLLISIONS OCCURRED WITH EQUIPMENT OR STAFF. NO PHOTOGRAPHIC IMAGES OR VIDEO RECORDINGS ARE AVAILABLE FOR REVIEW.

  Patient problems: Insufficient Information

  MAUDE report 24793676 ↗
• MalfunctionFeb 5, 2026Unintended System Motion

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270104 ↗
• MalfunctionDec 15, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT MOVEMENTS WERE NOT ACCURATE. THE INSTRUMENT WAS LOOSE NEAR THE TIP, DESCRIBED AS "FLOPPY". THE PROCEDURE WAS COMPLETED, AND NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810080 ↗
• MalfunctionNov 24, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE CADIERE FORCEPS INSTRUMENT MOVED IN THE OPPOSITE DIRECTION OF THE SURGEON'S COMMANDS. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640120 ↗
• MalfunctionNov 17, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT MOVED IN THE OPPOSITE DIRECTION OF THE SURGEON'S COMMANDS. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576916 ↗
• MalfunctionOct 29, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT WAS BEING RETURNED BECAUSE IT DID NOT WORK AND MALFUNCTIONED. THE INSTRUMENT MOVEMENTS DID NOT CORRESPOND TO THE CONSOLE SURGEON AND HAD NON-INTUITIVE MOTION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE DISTRIBUTOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT MOVEMENTS DID NOT CORRESPOND TO THE CONSOLE SURGEON AND HAD NON-INTUITIVE MOTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23420486 ↗
• MalfunctionJul 1, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT WAS BENDING IN THE OPPOSITE DIRECTION TO THE SURGEON'S COMMAND. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22377507 ↗
• MalfunctionJun 4, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT MOVED IN THE OPPOSITE DIRECTION FROM THE INPUT. THE CUSTOMER RESEATED THE INSTRUMENT, BUT THE ISSUE REMAINED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: A NEW INSTRUMENT WAS USED TO RESOLVE THE ISSUE WITH THE CADIERE FORCEPS INSTRUMENT. THE INSTRUMENT WAS NOT ATTACHED TO ANY DRAPE. THERE WERE NO EXTERNAL COLLISIONS INVOLVING THE SYSTEM ARM AND EXTERNAL OPERATING ROOM EQUIPMENT OR STAFF. THE DEVICE WAS INSPECTED PRIOR TO USE, AND THERE WAS NO OBVIOUS DAMAGE OR ANYTHING OUT OF THE ORDINARY OBSERVED. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146962 ↗
• MalfunctionMay 29, 2025Unintended System Motion; Unintended System Motion

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107636 ↗
• MalfunctionMay 15, 2025Unintended System Motion; Unintended System Motion

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029568 ↗
• MalfunctionMay 13, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT HAD A LOOSE CABLE AND WOULD NOT ROTATE AT THE WRIST. THE CUSTOMER REPLACED THE CADIERE FORCEPS 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 22015154 ↗
• MalfunctionMay 4, 2025Unintended System Motion; Unintended System Motion

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955846 ↗
• MalfunctionSep 6, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT DOES NOT FOLLOW THE MOVEMENTS OF THE SURGEON. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI SAME INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP AND OBTAINED ADDITIONAL INFORMATION. THE ISSUE OCCURRED WITH THE SURGEON¿S HEAD INSIDE THE SURGEON CONSOLE¿S HIGH RESOLUTION STEREO VIEWER. THE ISSUE OCCURRED 20 MINUTES INTO THE PROCEDURE. THE INSTRUMENT DID MOVE IN THE INTENDED DIRECTION. THE TIMING OF THE INSTRUMENT MOVEMENT WAS NO APPROPRIATE. THERE WAS NO INTERFERENCE AND NO SHAKINESS OR FRICTION. THERE WERE NO EXTERNAL COLLISIONS AND THE ISSUE WAS INTERMITTENT. THE INSTRUMENT WAS REINSTALLED TO RESOLVE THE ISSUE. THE DRAPE WAS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20163379 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED CHOLECYSTECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING THAT REQUIRED SURGICAL INTERVENTION. WHILE THE CADIERE FORCEPS INSTRUMENT RETRACTING THE GALLBLADDER WAS NOTED TO HAVE A BROKEN WIRE, THE SURGEON NOTED THAT THE BLEEDING WAS ANTICIPATED AND REPORTED AS NEGLIGIBLE. THE BLEEDING WAS RESOLVED BY USING A MARYLAND BIPOLAR FORCEPS INSTRUMENT FOR CAUTERIZATION; TRANSFUSION OF BLOOD PRODUCTS WAS NOT REQUIRED. THE SURGEON STATED THAT THE EVENT WAS NOT CAUSED BY A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20042093 ↗
• MalfunctionMay 6, 2023Break; Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE CADIERE FORCEPS INSTRUMENT HAD A BROKEN CABLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883597 ↗
• MalfunctionAug 31, 2022Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PYELOPLASTY SURGICAL PROCEDURE THAT THE SINGLE PORT CADIERE FORCEPS INSTRUMENT CONTROL WAS REVERSED. WHEN ATTEMPTING TO MOVE RIGHT, THE INSTRUMENT MOVED LEFT. WHEN ATTEMPTING TO MOVE THE INSTRUMENT UP, IT WOULD MOVE DOWN. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT 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 15332226 ↗