None 430013Recalls & reported problems

Summary

The FDA's MAUDE database contains 139 adverse event reports that list this exact device (DI 00886874113486), received between Jan 8, 2025 and Sep 29, 2026 — classified as 1 injury, 138 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (76 reports).

2 FDA recall records 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. May 12, 2025Open, Classified

   Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall.

   Z-2722-2026 · Root cause: Process control · FDA record ↗

2. Oct 25, 2018Terminated

   The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.

   Z-1906-2020 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 139 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937655 ↗
• MalfunctionSep 4, 2026Use of Device Problem

  Patient problems: Insufficient Information

  MAUDE report 50621783 ↗
• MalfunctionSep 1, 2026Device Difficult to Setup or Prepare

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50545706 ↗
• MalfunctionAug 19, 2026Break; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50326421 ↗
• MalfunctionJul 29, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50071197 ↗
• MalfunctionMay 26, 2026No Device Output

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25278791 ↗
• MalfunctionMay 18, 2026Installation-Related Problem

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SP INSTRUMENT ARM DRAPE DID NOT REMAIN ATTACHED TO THE CIRCULAR CROWN OF THE SYSTEM. THE USER CONTINUED AND COMPLETED THE PROCEDURE WITH NO FURTHER ISSUES. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. A PROCEDURE DELAY OF 15 MINUTES WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: A NEW ARM DRAPE WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211183 ↗
• MalfunctionApr 30, 2026No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, USER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT ON ARM 1 COULD NOT BE DETACHED, AND BOTH THE INSTRUMENT REMOVAL AND INSTRUMENT RELEASE BUTTONS WERE UNRESPONSIVE. THE TSE WAS INFORMED THAT THE INSTRUMENT WAS ULTIMATELY REMOVED BY HOLDING DOWN THE INSTRUMENT REMOVAL BUTTON WHILE PULLING ON THE INSTRUMENT. THE TSE SUSPECTED POOR CONTACT AT THE DRAPE STERILE ADAPTER AND REQUESTED THAT IT BE RECONNECTED, AFTER WHICH ARM 1 RECOGNIZED THE INSTRUMENT NORMALLY. SUBSEQUENTLY, ARM 3 FAILED TO RECOGNIZE AN INSTRUMENT EVEN AFTER IT WAS REPLACED, AND TSE SUSPECTED A FAULTY DRAPE AND ADVISED DRAPE REPLACEMENT. THE USER CONTINUED WITH THE PROCEDURE USING THE SAME SYSTEM CONFIGURATION WITHOUT FURTHER ISSUES. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046899 ↗
• MalfunctionApr 29, 2026No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE SINGLE PORT (SP) INSTRUMENT ARM DRAPE JOINT HAD SEPARATED AND FALLEN OFF. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS ARE AVAILABLE REGARDING THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 25035489 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INSTRUMENT ARM DRAPE ACCESSORY WHITE ADAPTER PART DETACHED AND BECAME UNUSABLE DURING THE ARM REPLACEMENT PROCESS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021674 ↗
• MalfunctionApr 28, 2026No Device Output

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 25011434 ↗
• MalfunctionApr 24, 2026Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, ONE OF THE INSTRUMENT'S PLATES WAS DEFECTIVE AND WOULD NOT ENGAGE DURING DRAPING. ANOTHER WAS USED TO DRAPE THE SINGLE PORT (SP) ROBOT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24987843 ↗
• MalfunctionApr 23, 2026No Device Output

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24974265 ↗
• MalfunctionApr 23, 2026Use of Device Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24972570 ↗
• MalfunctionApr 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INSTRUMENT ARM DRAPE DETACHED FROM THE CART AND BECAME CONTAMINATED WHILE TRANSITIONING TO STEP 2. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24969141 ↗
• MalfunctionApr 20, 2026No Device Output

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24933498 ↗
• MalfunctionApr 17, 2026Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A SINGLE PORT ARM DRAPE HAD A RECOGNITION FAILURE. THE PROCEDURE WAS COMPLETED. NO REPORTED KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24917239 ↗
• MalfunctionApr 17, 2026Use of Device Problem

  IT WAS REPORTED PRIOR TO THE START OF DA VINCI ASSISTED SURGICAL PROCEDURE; THE INSTRUMENT ARM DRAPE COULD NOT BE INSTALLED. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912863 ↗
• MalfunctionApr 16, 2026Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INSTRUMENT ARM DRAPE CONTINUOUSLY DISPLAYED ERRORS WHEN THE MECHANISM WAS MOUNTED ON UNIVERSAL SURGICAL MANIPULATOR (USM1). SINCE THE SAME ERROR OCCURRED EVEN AFTER REATTACHING THE DRAPE AND CHANGING THE MECHANISM, THE INSTRUMENT ARM DRAPE WAS REPLACED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24905895 ↗
• MalfunctionApr 16, 2026Use of Device Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901302 ↗
• MalfunctionApr 13, 2026Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO START OF DA VINCI-ASSISTED OVARIAN CYSTECTOMY SURGICAL PROCEDURE, THE INSTRUMENT ARM DRAPE WAS APPLIED TO THE SP ROBOT. HOWEVER, THE UPPER MAGNETIC PART WAS ATTACHED INCORRECTLY AND DID NOT FIT THE MAGNETIC ATTACHMENT SITE OF THE EQUIPMENT. NO MATTER HOW HARD IT WAS PULLED, ONLY THE OPPOSITE MAGNET DETACHED, MAKING IT IMPOSSIBLE TO CREATE A DRAPE; THEREFORE, THE SURGERY WAS PERFORMED AFTER REPLACING IT WITH A NEW INSTRUMENT ARM DRAPE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858381 ↗
• MalfunctionApr 11, 2026No Device Output

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SP ARM DRAPE DISPLAYED CONTINUOUS ERROR SIGNS WHEN CAMERA WAS DRAPED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24849382 ↗
• MalfunctionApr 11, 2026No Device Output

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SP INSTRUMENT ARM DRAPE WAS REPEATEDLY INSERTED AND THE CONNECTION WAS SUCCESSFUL, BUT AN ERROR MESSAGE APPEARED. AFTER REPLACING IT WITH A NEW STRAP, NORMAL OPERATION RESUMED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24849078 ↗
• MalfunctionMar 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INSTRUMENT ARM DRAPE WAS FOUND TO HAVE RECOGNITION FAILURE. THERE WAS NO REPORT OF PATIENT INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24722947 ↗
• MalfunctionMar 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE WHEN TURNING THE HEAD OF THE PATIENT CART DURING DOCKING, THE DRAPE IS SEPARATED FROM THE PATIENT CART. WHEN TURN THE HEAD IT TURNS STIFFLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24722937 ↗