EndoWrist 470347Recalls & reported problems
Intuitive Surgical, Inc. · TIP-UP FENESTRATED GRASPER · Class 2
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This EndoWrist grasper is used with the da Vinci surgical robot. Its 2,111 adverse event reports mostly describe frayed, torn or broken parts, and some mention foreign bodies in patients. The reports include no deaths and 85 injuries. There are 2 open recalls: one from 2023 for a manufacturing issue that could cause grip breakage and steel fragments in patients, and one from 2024 for frayed or broken grip cables.
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
- 2,082
- Deaths reported
- 0
- Injuries reported
- 86
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 2,082 adverse event reports that list this exact device (DI 00886874112496), received between Feb 28, 2017 and Sep 30, 2026 — classified as 86 injuries, 1,996 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (811 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0869-2025 · Root cause: Process change control · FDA record ↗
- Jun 12, 2023Open, Classified
Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.
Z-2059-2023 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Material Split, Cut or Torn811
- Material Frayed659
- Detachment of Device or Device Component164
- Break158
- Material Fragmentation104
- No Apparent Adverse Event67
- Difficult to Remove35
- Unintended Movement22
Patient problems
- No Clinical Signs, Symptoms or Conditions1,402
- Insufficient Information599
- No Known Impact Or Consequence To Patient35
- Foreign Body In Patient29
- Unspecified Tissue Injury11
- Hemorrhage/Blood Loss/Bleeding5
- Bowel Perforation3
- Injury3
Recent adverse event reports
The 25 most recent of 2,082 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 50954335 ↗MalfunctionSep 30, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954064 ↗MalfunctionSep 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 50942402 ↗MalfunctionSep 28, 2026Material Frayed
Patient problems: Insufficient Information
MAUDE report 50926080 ↗MalfunctionSep 28, 2026Material Frayed
Patient problems: Insufficient Information
MAUDE report 50926055 ↗MalfunctionSep 28, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925127 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925070 ↗MalfunctionSep 28, 2026Detachment of Device or Device Component
It was reported that during a da Vinci-assisted surgical procedure, a Tip-Up Fenestrated Grasper instrument became stuck in the patient's chest because the distal end came out of the forceps sheath, the forceps jammed, making it impossible for the surgeon to manipulate it from the robot console. 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 was removed by hand. All the parts were still attached to the instrument. No fragment fell into the patient. The procedure was completed using a replacement instrument.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910822 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905842 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905841 ↗MalfunctionSep 25, 2026Material Frayed
Patient problems: Insufficient Information
MAUDE report 50905779 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905611 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905540 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905267 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905212 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905124 ↗MalfunctionSep 25, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905119 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905022 ↗MalfunctionSep 25, 2026Material Frayed
Patient problems: Insufficient Information
MAUDE report 50905010 ↗MalfunctionSep 25, 2026No Apparent Adverse Event
Patient problems: Insufficient Information
MAUDE report 50904899 ↗MalfunctionSep 25, 2026No Apparent Adverse Event
Patient problems: Insufficient Information
MAUDE report 50904889 ↗MalfunctionSep 25, 2026Unintended System Motion
It was reported that during a da Vinci-assisted surgical procedure, a Tip-Up Fenestrated Grasper instrument was observed Moving erratically. The procedure was completed with no reported injury.
Patient problems: Insufficient Information
MAUDE report 50900400 ↗MalfunctionSep 25, 2026Break
It was reported that prior to the start of a da Vinci-assisted surgical procedure, a 8mm Tip-Up Fenestrated Grasper instrument was observed with the tip damaged.The procedure was completed as planned with no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893635 ↗MalfunctionSep 25, 2026Unintended Movement
It was reported that after a da Vinci-assisted surgical procedure, the Tip Up Fenestrated Grasper instrument would not close. The procedure was completed with no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893583 ↗MalfunctionSep 24, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891420 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.