EndoWrist 470001Recalls & reported problems
Intuitive Surgical, Inc. · POTTS SCISSORS · 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 EndoWrist Potts scissors is a computer-controlled surgical instrument. The 25 reports mostly describe split or frayed cables and bent or broken tips, sometimes with fragments, and mention no deaths or injuries. There is 1 open recall started in December 2024 about frayed or broken grip cables on reusable jaw 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
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00886874112120), received between Apr 7, 2023 and May 31, 2026 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (8 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-0848-2025 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Split, Cut or Torn8
- Material Twisted/Bent4
- Break3
- Material Fragmentation3
- Difficult to Open or Close2
- Appropriate Device Problem Term/Code Not Available1
- Defective Component1
- Failure to Cut1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Insufficient Information6
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 31, 2026Break
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 25341528 ↗MalfunctionMay 22, 2026Material Twisted/Bent
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 25262561 ↗MalfunctionMay 14, 2026Material Twisted/Bent
IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE 8MM POTTS SCISSORS INSTRUMENT TIP WAS BROKEN AND BENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25178114 ↗MalfunctionMay 6, 2026Material Twisted/Bent
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 25090151 ↗MalfunctionApr 22, 2026Material Twisted/Bent
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 24959303 ↗MalfunctionApr 22, 2026Difficult to Open or Close
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE POTTS SCISSOR INSTRUMENT HAD A "BLADE GAP" WHEN IT WAS INSTALLED ON THE ROBOTIC ARM. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24948738 ↗MalfunctionApr 1, 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 24759809 ↗MalfunctionApr 1, 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 24759804 ↗MalfunctionMar 18, 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 24632114 ↗MalfunctionJan 29, 2026Unintended Movement
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM POTTS SCISSORS INSTRUMENT TIPS ARE NOT CLOSING ALL THE WAY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24206847 ↗MalfunctionJan 23, 2026Difficult to Open or Close
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM POTTS SCISSORS INSTRUMENT DID NOT CLOSE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 24171182 ↗MalfunctionNov 20, 2025Material Split, Cut or Torn; Material 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 23611110 ↗MalfunctionNov 20, 2025Material Split, Cut or Torn; Material 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 23611092 ↗MalfunctionOct 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23373867 ↗MalfunctionAug 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22721560 ↗MalfunctionJul 16, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE 8MM POTTS SCISSORS ARE NOT FUNCTIONING PROPERLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 22516886 ↗MalfunctionJun 19, 2025Material Split, Cut or Torn; Material 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 22291100 ↗MalfunctionMay 6, 2025Defective Component; Defective Component
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE POTTS SCISSORS WAS DEFECTIVE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE DAMAGE WAS AT THE DISTAL END AND THE LEAVES DID NOT CLOSE PROPERLY. THERE WERE NO BROKEN CABLES, NO PATIENT INJURY AND NO PROCEDURE WERE DELAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21972652 ↗MalfunctionMay 1, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21946333 ↗MalfunctionApr 25, 2025Break; Break
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Insufficient Information
MAUDE report 21914004 ↗MalfunctionNov 20, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN UNKNOWN ISSUE WITH THE POTTS SCISSORS INSTRUMENT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND GATHERED THE FOLLOWING INFORMATION: THERE WAS NO REPORT OF FRAGMENTS FALLING FROM THE DEVICE WHILE USED WITHIN A PATIENT.
Patient problems: Insufficient Information
MAUDE report 20731258 ↗MalfunctionAug 21, 2024Break; Break
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20013999 ↗MalfunctionJul 11, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE POTTS SCISSORS INSTRUMENT HAD A BROKEN PULLEY WIRE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19717536 ↗MalfunctionJan 9, 2024Material Fragmentation; Material Fragmentation
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18472685 ↗MalfunctionApr 7, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE POTTS SCISSORS INSTRUMENT WERE DAMAGED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 16704620 ↗
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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