Skip to content

EndoWrist 470093Recalls & reported problems

Intuitive Surgical, Inc. · PROGRASP FORCEPS · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Intuitive Surgical EndoWrist ProGrasp forceps is a computer-controlled surgical instrument used with da Vinci robotic systems. Of its 172 reports, 11 are filed as injuries, and many describe cables that split, tear, or break, along with parts detaching. The reports mention no deaths. The instrument has 1 open recall, from December 2024, over frayed or broken grip cables on reusable instruments with jaws.

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
171
Deaths reported
0
Injuries reported
11
Recalls naming it
1

Summary

The FDA's MAUDE database contains 171 adverse event reports that list this exact device (DI 00886874112267), received between Feb 16, 2017 and Sep 30, 2026 — classified as 11 injuries, 160 malfunctions.

The most frequently reported specific device problem is “Break” (49 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 16 reportsApr 2025: 3 reportsMay 2025: 5 reportsJun 2025: 1 reportsJul 2025: 9 reportsAug 2025: 7 reportsSep 2025: 1 reportsOct 2025: 1 reportsNov 2025: 5 reportsDec 2025: 7 reportsJan 2026: 5 reportsFeb 2026: 14 reportsMar 2026: 4 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports20242025202616
Last 36 months. The most recent month may be incomplete.

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-0854-2025 · Root cause: Process change control · FDA record ↗

Most reported problems

Device problems

  • Break49
  • Material Split, Cut or Torn49
  • Detachment of Device or Device Component21
  • Material Fragmentation19
  • Device Dislodged or Dislocated12
  • Detachment Of Device Component11
  • Material Frayed11
  • Difficult to Open or Close4

Patient problems

  • No Clinical Signs, Symptoms or Conditions100
  • No Known Impact Or Consequence To Patient42
  • Insufficient Information18
  • Device Embedded In Tissue or Plaque6
  • Foreign Body In Patient2
  • No Patient Involvement2
  • Injury1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 25 most recent of 171 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 50954211 ↗
  • MalfunctionApr 1, 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 24759813 ↗
  • MalfunctionMar 24, 2026Material Fragmentation

    IT WAS REPORTED THAT DURING A TRAINING/DEMO THE PROGRASP FORCEPS CABLE BROKE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Patient problems: Insufficient Information

    MAUDE report 24671898 ↗
  • MalfunctionMar 17, 2026Material Split, Cut or Torn

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Patient problems: Insufficient Information

    MAUDE report 24614416 ↗
  • MalfunctionMar 16, 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 24612566 ↗
  • MalfunctionMar 12, 2026Unintended Movement

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT 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 24587122 ↗
  • MalfunctionFeb 27, 2026Unintended Movement

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE A PROGRASP FORCEPS INSTRUMENT HAD A INTRAOPERATIVE FAILURE TO OPEN THE FORCEPS PROPERLY THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24467875 ↗
  • MalfunctionFeb 27, 2026Material Split, Cut or Torn

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Patient problems: Insufficient Information

    MAUDE report 24466844 ↗
  • MalfunctionFeb 25, 2026Difficult to Open or Close

    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 24448859 ↗
  • MalfunctionFeb 25, 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 24443850 ↗
  • MalfunctionFeb 25, 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 24441437 ↗
  • MalfunctionFeb 25, 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 24441404 ↗
  • MalfunctionFeb 25, 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 24438863 ↗
  • MalfunctionFeb 24, 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 24434540 ↗
  • MalfunctionFeb 24, 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 24425450 ↗
  • MalfunctionFeb 24, 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 24425441 ↗
  • MalfunctionFeb 24, 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 24425263 ↗
  • MalfunctionFeb 24, 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 24425262 ↗
  • MalfunctionFeb 24, 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 24425260 ↗
  • MalfunctionFeb 6, 2026No Apparent Adverse Event

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY (WITHOUT LYMPHADENECTOMY) SURGICAL PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT JAWS WERE NOT CONTROLLED BY THE MAIN BLADE. 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 ISSUE OCCURRED WHILE THE SURGEON¿S HEAD WAS INSIDE THE SURGEON CONSOLE¿S HIGH RESOLUTION STEREO VIEWER AND DURING ACTIVE INSTRUMENT MANIPULATION. INSTRUMENT MOVEMENTS MATCHED THE SURGEON¿S INTENDED DIRECTION AND SCALE, AND TIMING WAS APPROPRIATE WITHOUT DELAY OR LAG. THE INSTRUMENT WAS NOT STATIC, THERE WERE NO VISIBLE BROKEN CABLES AT THE INSTRUMENT WRIST, AND NO INJURY WAS REPORTED TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24284657 ↗
  • MalfunctionJan 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: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24155214 ↗
  • MalfunctionJan 22, 2026Material Split, Cut or Torn

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24154429 ↗
  • MalfunctionJan 14, 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: Insufficient Information

    MAUDE report 24074078 ↗
  • MalfunctionJan 13, 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 24061479 ↗
  • MalfunctionJan 13, 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 24061197 ↗

Other System,surgical,computer controlled instrument devices

All System,surgical,computer controlled instrument devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.