EndoWrist 471344Recalls & reported problems

Summary

The FDA's MAUDE database contains 233 adverse event reports that list this exact device (DI 00886874121511), received between Aug 18, 2021 and Jul 28, 2026 — classified as 5 injuries, 228 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (138 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 16, 2026.

Recalls naming this device

1. Dec 19, 2024Open, Classified

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

   Z-0881-2025 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 233 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Insufficient Device Problem Information

  It was reported that during a da Vinci-assisted right pulmonary lobectomy and pulmonary segmentectomy with mediastinal mass resection procedure, bleeding was noted near the root of the superior pulmonary vein, prompting conversion to open thoracotomy. The bronchus was transected using a SureForm 45 Curved-Tip Stapler instrument with a SureForm 45 Black Reload. Approximately 15¿20 minutes later, bleeding from the bronchial artery was observed. The surgeon reported that the bleeding was associated with an unspecified technique performed while using the Curved Bipolar Dissector instrument. A da Vinci system, instrument, or accessory did not cause or contribute to the reported event. Hemostasis was successfully achieved using a gauze bandage and compression using robotic instruments and the assistant¿s forceps. The estimated blood loss was not provided; however, the patient did not require a blood transfusion. As a precaution, the proctor elected to convert to a small thoracotomy via anterior port #4. The procedure was completed without further complications and a delay of greater than 30 minutes. The patient had no postoperative complications, there are no concerns for long-term seque

  Patient problems: Great Vessel Perforation

  MAUDE report 50055990 ↗
• MalfunctionJul 28, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50049192 ↗
• MalfunctionJul 7, 2026Thermal Decomposition of Device; Smoking

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, SMOKE GENERATED INSIDE THE PATIENT ABDOMEN WHEN USING THE CURVED BIPOLAR DISSECTOR. 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 CUSTOMER CLARIFIED THAT THE SMOKE ORIGINATED FROM BETWEEN THE INSTRUMENT JAWS. THERE WAS NO ARCING OBSERVED HOWEVER, SMOKE CONTINUED TO RISE, SO THE CUSTOMER TRIED WIPING IT, BUT THE SMOKE BILLOWED UP AS IF A FIRE WERE ABOUT TO BREAK OUT. IT WAS NOT SMOKE CAUSED BY BURNING PROTEIN. THERE WAS NO PATIENT INJURY DUE TO THE ISSUE, AND NO INSTRUMENT COLLISION OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25742451 ↗
• MalfunctionMay 27, 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 25309614 ↗
• MalfunctionMay 21, 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 25238124 ↗
• MalfunctionMay 19, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE CURVED BIPOLAR DISSECTOR HAD THE TIPS BENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER HOWEVER THE CUSTOMER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25223462 ↗
• MalfunctionMay 19, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE 8MM CURVED BIPOLAR DISSECTOR INSTRUMENT ENERGY WAS NOT WORKING WHEN ACTIVATED. THE TIP OF THE INSTRUMENT MOVEMENT WAS NOT WORKING PROPERLY. THE INSTRUMENT WASN'T ARTICULATING AS INTENDED, PER THE SURGEON. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222571 ↗
• MalfunctionMay 9, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TRANSTHORACIC ESOPHAGECTOMY NECK ANASTOMOSIS SURGICAL PROCEDURE, THE CURVED BIPOLAR DISSECTOR INSTRUMENT TIP IS NOT LONGER OPENING. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO PIN STICKING OUT, NOR AN EVENT ON WHICH THE JAWS COULD NOT CLOSE OR THAT THE WRIST COULD NOT BE STRAIGHTENED DUE TO ANY PHYSICAL DAMAGE. THE INSTRUMENT IS AVAILABLE FOR RETURN. NO PHOTOS OR VIDEOS ARE AVAILABLE. NO ADDITIONAL PORTS WERE MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25131884 ↗
• MalfunctionMay 7, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25119055 ↗
• MalfunctionApr 29, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO THE START OF A VINCI-ASSISTED SURGICAL PROCEDURE, THE 8 MM, CURVED BIPOLAR DISSECTOR INSTRUMENT HAD A BROKEN, DAMAGED BLACK CONDUCTOR WIRE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037208 ↗
• MalfunctionApr 23, 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 24972475 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT THE TIP OF A CURVED BIPOLAR DISSECTOR INSTRUMENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24934447 ↗
• MalfunctionApr 13, 2026Break

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CURVED BIPOLAR DISSECTOR INSTRUMENT HAD SURFACE DAMAGE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24866656 ↗
• MalfunctionApr 11, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24852833 ↗
• MalfunctionApr 2, 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 24771302 ↗
• MalfunctionMar 30, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24721496 ↗
• MalfunctionMar 30, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24721157 ↗
• MalfunctionMar 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: Insufficient Information

  MAUDE report 24563747 ↗
• MalfunctionMar 2, 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 24491100 ↗
• MalfunctionMar 2, 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. ON 11/18/2024, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT (B)(4) STATING: CABLE ON DA VINCI XI CURVED BIPOLAR DISSECTOR SNAPPED.

  Patient problems: Insufficient Information

  MAUDE report 24478168 ↗
• MalfunctionMar 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM CURVED BIPOLAR DISSECTOR INSTRUMENT HAD LOOSE WIRES. NO FRAGMENTS FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED BUT THE PATIENT OUTCOME IS UNKNOWN. 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 24477889 ↗
• MalfunctionFeb 27, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CURVED BIPOLAR DISSECTOR HAD A FRAYED AND EXPOSED WIRE. THERE WAS NO REPORTED INJURY. ON 01/03/2025, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT (B)(4). STATING: CURVED BIPOLAR DISSECTOR BROKEN WITH WIRES EXPOSED NEAR TIP. ITEM REMOVED FROM FIELD AND REPLACED WITH PEEL PACK. NO HARM TO PATIENT. 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 24477244 ↗
• MalfunctionFeb 27, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROCEDURE_NAME SURGICAL PROCEDURE, THE CUSTOMER IDENTIFIED A WIRE BROKE IN THE CURVED BIPOLAR DISSECTOR. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24467287 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CURVED BIPOLAR DISSECTOR INSTRUMENT DEVELOPED A BROKEN CONDUCTOR WIRE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24467015 ↗
• MalfunctionFeb 26, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CURVED BIPOLAR DISSECTOR HAD A TORN WIRE. THERE WAS A DELAY OF LESS THAN 15 MINUTES. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24465451 ↗