EndoWrist 470207Recalls & reported problems
Intuitive Surgical, Inc. · TENACULUM FORCEPS · Class 2
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Intuitive EndoWrist tenaculum forceps is a computer-controlled surgical instrument. Many of the 1,339 reports describe material breaking into fragments, splitting or tearing, parts detaching, or cables fraying or breaking. The reports include no deaths and 31 injuries. Reports fell from 392 in the prior 12 months to 207 in the latest 12 months. 2 recalls name this device, both open, covering frayed or broken grip cables and pitch cable failures in forceps and small instruments.
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
- 1,336
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1,336 adverse event reports that list this exact device (DI 00886874112366), received between May 4, 2017 and Sep 28, 2026 — classified as 32 injuries, 1,304 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (401 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 an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Z-0923-2025 · Root cause: Device Design · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0860-2025 · Root cause: Process change control · FDA record ↗
Most reported problems
Device problems
- Material Fragmentation401
- Material Split, Cut or Torn365
- Detachment of Device or Device Component300
- Break101
- Material Frayed97
- No Apparent Adverse Event35
- Unintended Movement18
- No Device Output17
Patient problems
- No Clinical Signs, Symptoms or Conditions1,021
- Insufficient Information235
- No Known Impact Or Consequence To Patient63
- Foreign Body In Patient15
- Device Embedded In Tissue or Plaque3
- No Patient Involvement2
- Unspecified Tissue Injury2
Recent adverse event reports
The 25 most recent of 1,336 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925325 ↗MalfunctionSep 25, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904720 ↗MalfunctionSep 24, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891291 ↗MalfunctionSep 24, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891252 ↗MalfunctionSep 24, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891000 ↗InjurySep 22, 2026Material Split, Cut or Torn
It was reported that after a da Vinci-assisted radical prostatectomy without lymphadenectomy procedure, the wire on a Tenaculum Forceps instrument completely snapped during the procedure. It is unknown whether any wire fragment detached and was retained in the patient. An X-ray was taken to assess for any retained foreign body. The procedure was completed.Intuitive Surgical, Inc. (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: Insufficient Information
MAUDE report 50852993 ↗MalfunctionSep 4, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50618884 ↗MalfunctionAug 12, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229770 ↗MalfunctionAug 12, 2026No Device Output
Patient problems: Insufficient Information
MAUDE report 50228188 ↗MalfunctionAug 11, 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 50203121 ↗MalfunctionAug 7, 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.
Patient problems: Insufficient Information
MAUDE report 50183456 ↗MalfunctionMay 31, 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 25341542 ↗MalfunctionMay 29, 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 25339158 ↗MalfunctionMay 28, 2026Appropriate Device Problem Term/Code Not Available
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 25323831 ↗MalfunctionMay 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 25261525 ↗MalfunctionMay 11, 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.
Patient problems: Insufficient Information
MAUDE report 25143856 ↗MalfunctionMay 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 25131865 ↗MalfunctionMay 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 25131856 ↗MalfunctionMay 7, 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 25118788 ↗MalfunctionMay 6, 2026Difficult to Remove; Difficult to Open or Close
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT TENACULUM FORCEPS (TF) INSTRUMENT WAS STUCK ON THE TISSUE. THE CUSTOMER WAS TRYING TO USE AN INSTRUMENT RELEASE KIT (IRK) TO REMOVE THE INSTRUMENT; HOWEVER, IT WAS FOUND THAT A BROKEN INTERNAL CABLING PREVENTED THE CUSTOMER FROM OPENING THE INSTRUMENTS JAWS WITH THE IRK. THE CUSTOMER HAD TO OPEN THE INSTRUMENTS JAWS MANUALLY. THE CUSTOMER STATED THAT THE INSTRUMENT WAS ON ITS LAST USE. THE TSE ADVISED THE CUSTOMER TO RETURN THE INSTRUMENT FOR FAILURE ANALYSIS. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25102171 ↗MalfunctionMay 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: Insufficient Information
MAUDE report 25090356 ↗MalfunctionMay 6, 2026Detachment of Device or Device Component
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 25090340 ↗MalfunctionMay 6, 2026Break
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TENACULUM FORCEPS WAS BROKEN. 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: Insufficient Information
MAUDE report 25090291 ↗MalfunctionMay 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 25090271 ↗MalfunctionMay 5, 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 25076630 ↗
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.