EndoWrist 471400Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,023 adverse event reports that list this exact device (DI 00886874121528), received between May 16, 2021 and Sep 30, 2026 — classified as 34 injuries, 989 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (632 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-0882-2025 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,023 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Split, Cut or Torn

  Patient problems: Insufficient Information

  MAUDE report 50954081 ↗
• MalfunctionSep 30, 2026Entrapment of Device; Difficult to Open or Close

  It was reported that during a da Vinci-assisted Radical Prostatectomy without Lymphadenectomy surgical procedure, the Surgeon lost complete vision on the console while the ProGrasp Forceps was grasping tissue. A system restart was done, but the system could not complete its self-checks since two instruments, a ProGrasp Forceps instrument and a Long Bipolar Grasper instrument, were grasping tissue. The system was put into an emergency state, and the instruments had to manually be opened with the emergency tool kit. The tissue was removed and the instruments were removed. The system was resumed for use, and the self-check was completed. The procedure was completed with no reported injury.Intuitive Surgical, Inc. (ISI) followed up with the Distributor Clinical Sales Representative (CSR) and obtained the following additional information: The customer confirmed the Long Bipolar Grasper was the other instrument involved and reported that both instruments were on tissue and had to be manually opened and removed using the Instrument Release Kit (IRK). Once the jaws were successfully opened, an assistant used a laparoscopic grasper to detach and remove the tissue caught between the jaws of

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948888 ↗
• MalfunctionSep 28, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925878 ↗
• MalfunctionSep 28, 2026Unintended Movement

  It was reported that the Long Bipolar Grasper instrument was not articulating properly. The customer reported event has no report of patient injury.

  Patient problems: Insufficient Information

  MAUDE report 50920112 ↗
• MalfunctionSep 25, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905859 ↗
• MalfunctionSep 25, 2026Material Frayed

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905835 ↗
• MalfunctionSep 24, 2026Material Split, Cut or Torn

  Patient problems: Insufficient Information

  MAUDE report 50891437 ↗
• MalfunctionSep 24, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891414 ↗
• MalfunctionSep 22, 2026No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861262 ↗
• MalfunctionSep 9, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50701082 ↗
• MalfunctionSep 4, 2026Thermal Decomposition of Device

  It was reported that during a da Vinci-assisted surgical procedure, the Long Bipolar Grasper instrument stopped coagulating and started to smell burnt. The ceramic component at the tip of the instrument appears to have overheated. The procedure was completed with no reported injury.ISI followed up with the initial reporter and obtained the following additional information: No arcing was observed. The non-energy instrument did not come into contact with or collide with another activated energy instrument during the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50618888 ↗
• MalfunctionAug 13, 2026Break; Thermal Decomposition of Device

  It was reported that during central processing, the Long Bipolar Grasper instrument white plastic at tip has a chunk missing on one side, looks like its dirty but a chunk was gone. The procedure was completed with no reported injury.Intuitive Surgical, Inc. (ISI) followed up with the initial reporter to obtain additional information; however, no further details are available regarding the reported event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50231314 ↗
• MalfunctionAug 12, 2026Material Fragmentation; Material Split, Cut or Torn

  Patient problems: Insufficient Information

  MAUDE report 50218064 ↗
• InjuryAug 10, 2026Material Fragmentation

  It was reported that during a da Vinci-assisted pulmonary lobectomy procedure, the Long Bipolar Grasper instrument tip broke. A fragment fell into the patient and was retrieved during the same procedure. The customer confirmed the fragment was located in a suction canister. It was removed and matched with the Long Bipolar Grasper instrument along the break line. The surgeon confirmed full fragment retrieval. No post-operative tests were performed. No additional procedure was required. The procedure was completed. There were no complications and the patient has not returned to the hospital due to experiencing any post-surgical complications related to the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50193631 ↗
• MalfunctionJul 7, 2026Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE LONG BIPOLAR GRASPER TIPS ARE BLACKENED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25741691 ↗
• MalfunctionJun 30, 2026Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM LONG BIPOLAR GRASPER INSTRUMENT HAD INTRA-ABDOMINAL SPARKS HAD OCCURRED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25672865 ↗
• MalfunctionJun 30, 2026Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE DISTAL TIP OF A LONG BIPOLAR GRASPER INSTRUMENT APPEARED MELTED/BURNT IN AREA OF MANIPULATOR WIRES. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS UNKNOWN IF ARCING WAS OBSERVED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25662478 ↗
• MalfunctionMay 27, 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 25309023 ↗
• MalfunctionMay 26, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE LONG BIPOLAR GRASPER CAUTERY WAS NOT WORKING ON THE INSTRUMENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25290162 ↗
• MalfunctionMay 22, 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 25262526 ↗
• MalfunctionMay 21, 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 25249124 ↗
• MalfunctionMay 19, 2026

  WOULDN'T RELEASE FROM ARM/STERILE ADAPTOR. PROCEDURE COMPLETED AND DEVICE PRIED OFF OF STERILE ADAPTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25215623 ↗
• MalfunctionMay 18, 2026Unintended Movement

  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 25210449 ↗
• MalfunctionMay 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: Insufficient Information

  MAUDE report 25196986 ↗
• MalfunctionMay 14, 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 25178321 ↗