EndoWrist 470172Recalls & reported problems
Intuitive Surgical, Inc. · MARYLAND BIPOLAR FORCEPS · Class 2
All models of EndoWrist (62)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Intuitive Surgical EndoWrist Maryland bipolar forceps has 754 reports, with 2 deaths and 23 injuries. Many reports describe parts that split, tear, or break, and some describe overheating or electrical sparking. A recall that started in December 2024 is open; it concerns 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
- 755
- Deaths reported
- 2
- Injuries reported
- 23
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 755 adverse event reports that list this exact device (DI 00886874112281), received between Dec 28, 2016 and Sep 28, 2026 — classified as 2 deaths, 23 injuries, 730 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (421 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Dec 19, 2024Class IIOpen, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0856-2025 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Split, Cut or Torn421
- Thermal Decomposition of Device86
- Break79
- Material Frayed32
- Detachment of Device or Device Component30
- Arcing28
- Material Fragmentation24
- No Device Output20
Patient problems
- No Clinical Signs, Symptoms or Conditions611
- Insufficient Information69
- No Known Impact Or Consequence To Patient50
- Foreign Body In Patient9
- Device Embedded In Tissue or Plaque8
- Hemorrhage/Blood Loss/Bleeding3
- Unspecified Tissue Injury3
- No Patient Involvement2
Recent adverse event reports
The 25 most recent of 755 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925512 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924979 ↗MalfunctionAug 12, 2026No Apparent Adverse Event
Patient problems: Insufficient Information
MAUDE report 50229483 ↗MalfunctionAug 6, 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 50167446 ↗MalfunctionAug 5, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50148697 ↗MalfunctionAug 3, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50108573 ↗MalfunctionJul 29, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50076387 ↗MalfunctionMay 27, 2026Unintended Movement
IT WAS REPORTED THAT THERE WAS A LIMITED/IMPRECISE MOTION ISSUE 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 25308182 ↗MalfunctionMay 27, 2026Unintended Movement
IT WAS REPORTED THAT THERE WAS A LIMITED/IMPRECISE MOTION ISSUE 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 25308178 ↗MalfunctionMay 27, 2026Unintended Movement
IT WAS REPORTED THAT THERE WAS A LIMITED/IMPRECISE MOTION ISSUE 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 25308175 ↗MalfunctionMay 6, 2026Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25090174 ↗MalfunctionMay 4, 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 25074184 ↗MalfunctionMay 1, 2026Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25054185 ↗MalfunctionMay 1, 2026Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25054179 ↗MalfunctionApr 29, 2026No Device Output
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS NOT IDENTIFIED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 25024519 ↗MalfunctionApr 10, 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 24838124 ↗MalfunctionApr 9, 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 24825043 ↗MalfunctionApr 9, 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 24825036 ↗MalfunctionApr 7, 2026Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24810010 ↗MalfunctionApr 3, 2026Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24776699 ↗MalfunctionApr 2, 2026Material Frayed
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24761938 ↗MalfunctionApr 2, 2026Material Frayed
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24761930 ↗MalfunctionApr 2, 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 24761927 ↗MalfunctionMar 30, 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 24722431 ↗MalfunctionMar 30, 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 24722185 ↗
Other System,surgical,computer controlled instrument devices
- EndoWrist 471205Intuitive Surgical, Inc. · System, surgical, computer controlled instrument1 recall14,225 reports
- EndoWrist 470179Intuitive Surgical, Inc. · System,surgical,computer controlled instrument2 recalls2 deaths10,156 reports
- EndoWrist 471093Intuitive Surgical, Inc. · System, surgical, computer controlled instrument1 recall8,581 reports
- EndoWrist 471172Intuitive Surgical, Inc. · System, surgical, computer controlled instrument1 recall1 death6,302 reports
- daVinci Xi 380652Intuitive Surgical, Inc. · System,surgical,computer controlled instrument2 recalls235 deaths5,316 reports
- daVinci Xi 381121Intuitive Surgical, Inc. · System,surgical,computer controlled instrument1 recall2 deaths4,310 reports
- EndoWrist 471405Intuitive Surgical, Inc. · System, surgical, computer controlled instrument1 recall1 death3,770 reports
- EndoWrist 470327Intuitive Surgical, Inc. · System,surgical,computer controlled instrument2 recalls2,273 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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