EndoWrist 470344Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00886874112489), received between Mar 18, 2019 and Sep 23, 2026 — classified as 5 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (15 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.

Recalls naming this device

1. Dec 19, 2024Class IIOpen, Classified

   Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

   Z-0868-2025 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026No Apparent Adverse Event

  It was reported that the customer experienced an issue with a Curved Bipolar Dissector instrument. The customer reported event has no report of patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864022 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CURVED BIPOLAR DISSECTOR WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 25090334 ↗
• InjuryApr 13, 2026Detachment of Device or Device Component

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24859011 ↗
• MalfunctionFeb 13, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24330013 ↗
• MalfunctionJan 30, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24228387 ↗
• MalfunctionDec 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  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 23721895 ↗
• 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 23611114 ↗
• 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 23611069 ↗
• MalfunctionOct 30, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  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 23430609 ↗
• MalfunctionOct 30, 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 23430583 ↗
• InjurySep 10, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION PROCEDURE, THE CURVED BIPOLAR DISSECTOR INSTRUMENT HAD A BROKEN TIP. THE CUSTOMER WAS UNSURE IF THE TIP BROKE WHILE IN USE OR BEFORE USE. THE CUSTOMER VISUALLY INSPECTED THE PATIENT'S ABDOMEN TO SEARCH FOR A POSSIBLE BROKEN TIP. THE CUSTOMER WAS PLANNING TO PERFORM AN X-RAY TO CONFIRM THAT NO FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS CONTINUED AS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23016864 ↗
• MalfunctionJul 18, 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 22548416 ↗
• MalfunctionJul 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  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 22548274 ↗
• MalfunctionMay 29, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 22102921 ↗
• MalfunctionMay 18, 2025Break; Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE TIP OF A CURVED BIPOLAR DISSECTOR INSTRUMENT WAS BROKEN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041255 ↗
• MalfunctionApr 3, 2025Arcing; Arcing

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATECTOMY - DISTAL SURGICAL PROCEDURE, THERE WAS ARCING. THE SURGEON USED A THIRD-PARTY GENERATOR (INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE VIO3) WITH THEIR PEDAL AND WITH OUR BIPOLAR CABLE. AT THE SURGERY USING THE CUT BIPOLAR WITH THE THIRD PARTY, IT CAUSED ARCING BETWEEN THE JAWS OF THE CURVED BIPOLAR DISSECTOR INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO DAMAGE TO THE INSTRUMENT WAS NOTED AFTER THE ARCING EVENT. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. A PIN GAGE WAS USED TO INSPECT THE CANNULA. THE BIPOLAR WAS CONNECTED WITH THE BIPOLAR CORD TO AN EXTERNAL ERBE VIO 3 GENERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21768298 ↗
• MalfunctionOct 12, 2024Break; Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE 8MM CURVED BIPOLAR DISSECTOR INSTRUMENT WAS FOUND TO HAVE BROKEN PLASTIC AT THE TIP OF THE INSTRUMENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20434955 ↗
• MalfunctionDec 11, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE CURVED BIPOLAR DISSECTOR HAD A NICK IN THE BLACK WIRE RIGHT BY THE RIGHT-SIDE JAW IN THE TAN-COLORED WIRE GROOVE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR NO REPORTED INJURY. INTUITIVE SURGICAL INC.(ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DAMAGE WITH CURVED BIPOLAR DISSECTOR WAS DISCOVERED IN STERILE PROCESSING WHENEVER THEY WERE INSPECTING FOR RE-PROCESSING. THEY HAVE NO INFORMATION ABOUT ¿ENERGIZED¿ FUNCTIONALITY FOR IT.

  Patient problems: Insufficient Information

  MAUDE report 18306506 ↗
• MalfunctionOct 30, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CURVED BIPOLAR DISSECTOR HAD MISALIGNED TIPS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18034447 ↗
• MalfunctionOct 13, 2023Unintended System Motion; Unintended System Motion

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17928598 ↗
• InjuryAug 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THAT A PLASTIC PIECE OF GEAR TIP BROKE OFF A CURVED BIPOLAR DISSECTOR INSTRUMENT IN THE PATIENT. THE PIECE WAS RETRIEVED. 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: Foreign Body In Patient

  MAUDE report 17595775 ↗
• MalfunctionMay 28, 2023No Device Output; No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROCEDURE, THE SURGEON WAS UNABLE TO GAIN CONTROL OF THE CURVED BIPOLAR DISSECTOR. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015909 ↗
• MalfunctionMay 25, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THE TIP OF THE CURVED BIPOLAR DISSECTOR DID NOT ALIGN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17000317 ↗
• MalfunctionMay 22, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGECTOMY SURGICAL PROCEDURE, THE CURVED BIPOLAR DISSECTOR INSTRUMENT TIPS WERE FOUND TO BE MISALIGNED. A BACKUP INSTRUMENT WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971571 ↗
• MalfunctionMay 22, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED PROSTATECTOMY WITH LYMPH NODE DISSECTION SURGICAL PROCEDURE, THERE WAS A MISSING PART ON THE CURVED BIPOLAR DISSECTOR INSTRUMENT'S BRANCHES. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971564 ↗