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EndoWrist;daVinci Si 420179Recalls & reported problems

Intuitive Surgical, Inc. · MONOPOLAR CURVED SCISSORS · Class 2

All models of EndoWrist;daVinci Si (35)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Intuitive EndoWrist monopolar curved scissors, a robotic surgery instrument, has 336 reports, 20 of them injuries and no deaths. The reports mostly describe material that splits, cuts or tears, and a few mention fragments in the patient. There are 2 open recalls: broken or frayed grip cables on reusable instruments, and cracks that can let plastic fragments fall, possibly into the patient.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
340
Deaths reported
0
Injuries reported
20
Recalls naming it
2

Summary

The FDA's MAUDE database contains 340 adverse event reports that list this exact device (DI 00886874111505), received between May 24, 2013 and Sep 30, 2026 — classified as 20 injuries, 320 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (219 reports).

2 FDA recall records name this device's identifier, 2 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.

Reports received per month

Nov 2023: 1 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 3 reportsJan 2025: 0 reportsFeb 2025: 6 reportsMar 2025: 48 reportsApr 2025: 11 reportsMay 2025: 21 reportsJun 2025: 19 reportsJul 2025: 10 reportsAug 2025: 16 reportsSep 2025: 24 reportsOct 2025: 10 reportsNov 2025: 7 reportsDec 2025: 21 reportsJan 2026: 22 reportsFeb 2026: 44 reportsMar 2026: 7 reportsApr 2026: 2 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 2 reportsSep 2026: 6 reportsOct 2026: 0 reports20242025202648
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Dec 9, 2025Class IIOpen, Classified

    Due to increased complaints for broken/frayed grip cables for reusable instruments.

    Z-1696-2026 · Root cause: Process control · Recall details · FDA record ↗

  2. Aug 15, 2018Class IIOpen, Classified

    Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extension tube to fall, including potentially into the patient.

    Z-3024-2018 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Device problems

  • Material Split, Cut or Torn219
  • Material Fragmentation21
  • Break15
  • Unintended Movement15
  • Detachment of Device or Device Component11
  • No Apparent Adverse Event10
  • Arcing8
  • Difficult to Open or Close7

Patient problems

  • No Clinical Signs, Symptoms or Conditions246
  • Insufficient Information67
  • Device Embedded In Tissue or Plaque7
  • Foreign Body In Patient6
  • Hemorrhage/Blood Loss/Bleeding4
  • Unspecified Tissue Injury4
  • Burn(s)3
  • Abscess1

Recent adverse event reports

The 25 most recent of 340 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 30, 2026Material Split, Cut or Torn

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50954541 ↗
  • MalfunctionSep 29, 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 50928036 ↗
  • MalfunctionSep 25, 2026Material Split, Cut or Torn

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50905531 ↗
  • MalfunctionSep 23, 2026Material Split, Cut or Torn

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50875640 ↗
  • MalfunctionSep 22, 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: Insufficient Information

    MAUDE report 50850393 ↗
  • MalfunctionSep 2, 2026High Readings

    Patient problems: Hypoglycemia

    MAUDE report 50575935 ↗
  • MalfunctionAug 11, 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 50216102 ↗
  • MalfunctionAug 11, 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. Review of the provided image is consistent with broken cable.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50215975 ↗
  • MalfunctionApr 28, 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 25022770 ↗
  • MalfunctionApr 21, 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 24946319 ↗
  • MalfunctionMar 26, 2026Unintended Movement

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, ONLY ONE SIDE OF THE MONOPOLAR CURVED SCISSORS COULD BE MOVED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT THE JAW OF THE INSTRUMENT WAS NOT STATIC IN THE OPEN POSITION, AND NO BROKEN CABLES WERE VISIBLE AT THE WRIST OF THE INSTRUMENT. THERE WERE NO REPORTS OF TISSUE INJURY CAUSED BY THE INSTRUMENT¿S JAWS, AND NO MATERIAL WAS FOUND MISSING OR DETACHED. ADDITIONALLY, NO PHOTOGRAPHIC OR VIDEO EVIDENCE WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24706772 ↗
  • MalfunctionMar 19, 2026No Device Output

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS NOT RECOGNIZED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24644283 ↗
  • MalfunctionMar 19, 2026Unintended Movement

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE JAWS OF 8 MM MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT COULD NOT BE OPENED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24644280 ↗
  • MalfunctionMar 13, 2026No Device Output

    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 24594740 ↗
  • MalfunctionMar 12, 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 24584860 ↗
  • MalfunctionMar 12, 2026No Device Output

    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 24584769 ↗
  • MalfunctionMar 2, 2026Material Split, Cut or Torn

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) HAD A BROKEN WIRE. THERE WAS A DELAY OF LESS THAN 15 MINUTES. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Patient problems: Insufficient Information

    MAUDE report 24478527 ↗
  • MalfunctionFeb 27, 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: Insufficient Information

    MAUDE report 24476352 ↗
  • MalfunctionFeb 27, 2026Material Split, Cut or Torn

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON REPORTED THE MONOPOLAR CURVED SCISSORS (MCS) DID NOT ROTATE COMPLETELY, WHEN MOVING THE CONTROLS IT WAS DIFFICULT TO ROTATE, BREAKING THE STEEL CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24468314 ↗
  • MalfunctionFeb 27, 2026Material Split, Cut or Torn

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS "STOPPED WORKING WHILE DOING SURGERY ON 5TH LIFE." THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY USING A BACK-UP INSTRUMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24467736 ↗
  • MalfunctionFeb 27, 2026Material Split, Cut or Torn

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS OBSERVED THAT CABLES BREAK DURING SURGERY, THERE WERE NO FORCED MOVEMENTS OR FRICTION WITH OTHER INSTRUMENTS, IT WAS REMOVED AND INSPECTED, SO IT WAS REPLACED WITH BACKUP INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24467735 ↗
  • MalfunctionFeb 27, 2026Material Split, Cut or Torn

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS OBSERVED THAT CABLES BREAK DURING SURGERY, THERE WERE NO FORCED MOVEMENTS OR FRICTION WITH OTHER INSTRUMENTS, IT WAS REMOVED AND INSPECTED, SO IT WAS REPLACED WITH BACKUP INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24467546 ↗
  • MalfunctionFeb 27, 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. ISI FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS ARE AVAILABLE REGARDING THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24467157 ↗
  • MalfunctionFeb 26, 2026Material Split, Cut or Torn

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) HAD EXPOSED WIRING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24453785 ↗
  • MalfunctionFeb 26, 2026Unintended Movement

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE JAWS OF THE MONOPOLAR CURVED SCISSORS (MCS) DID NOT OPEN OR CLOSE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24453109 ↗

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Sources and updates

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