EndoWrist 470183Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,553 adverse event reports that list this exact device (DI 00886874112311), received between Feb 20, 2017 and Sep 30, 2026 — classified as 3 deaths, 161 injuries, 1,387 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (317 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,553 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954078 ↗
• MalfunctionSep 30, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953607 ↗
• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952230 ↗
• MalfunctionSep 30, 2026Arcing

  It was reported the Permanent Cautery Hook instrument was twisted and loose. There was no report of any patient 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: Insufficient Information

  MAUDE report 50942439 ↗
• MalfunctionSep 29, 2026Break; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939788 ↗
• MalfunctionSep 29, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939709 ↗
• MalfunctionSep 28, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925582 ↗
• OtherSep 28, 2026Material Fragmentation

  Patient problems: Foreign Body In Patient

  MAUDE report 50924007 ↗
• MalfunctionSep 25, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905847 ↗
• MalfunctionSep 25, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905830 ↗
• MalfunctionSep 25, 2026No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905100 ↗
• MalfunctionSep 25, 2026Unintended System Motion

  It was reported that during a da Vinci-assisted surgical procedure, the Surgeon noticed the Permanent Cautery Hook instrument was not rotating correctly. The procedure was completed with no reported injury. Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained additional information: The issue occurred with the Surgeon¿s head inside the Surgeon Console¿s High Resolution Stereo Viewer while the Surgeon was attempting to manipulate instruments from the Surgeon Console. The Permanent Cautery Hook instrument was not rotating properly. The movements of the Surgeon scaled appropriately to the instrument. The timing of instrument movement was appropriate. There was no shakiness and/or friction observed. The instrument did not move in the intended direction. The issue was persistent. The instrument was changed to resolve the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899833 ↗
• MalfunctionSep 24, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891448 ↗
• MalfunctionSep 24, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890896 ↗
• MalfunctionSep 24, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890790 ↗
• InjurySep 24, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890594 ↗
• OtherSep 24, 2026Arcing; Insufficient Device Problem Information

  It was reported that during a da Vinci-assisted cholecystectomy procedure, a minor burn injury was observed on the inside of the patient¿s abdomen at the trocar site where the Permanent Cautery Hook (PCH) instrument was used. The injury was assessed as a first-degree burn with a black, charred appearance. No bleeding was observed, and the surgeon did not provide additional treatment. The procedure was successfully completed robotically. The patient had no postoperative complications, and there is no concern for long-term complications related to this event. The patient was discharged the following day without further issues.The surgeon was unable to determine the cause and reported no observed evidence of arcing during the procedure, but noted a potential contribution from the PCH instrument, green cable, or ERBE generator. No damage or abnormalities were identified on the instruments or accessories. An ERBE VIO dV generator was used with settings of 3 for monopolar cut/coag and bipolar coag. The grounding pad was inspected prior to use; no defects or abnormalities were identified, and it was properly placed on the patient¿s left thigh.

  Patient problems: Burn(s)

  MAUDE report 50885299 ↗
• MalfunctionSep 23, 2026Material Split, Cut or Torn

  Patient problems: Insufficient Information

  MAUDE report 50874921 ↗
• MalfunctionSep 23, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874426 ↗
• InjurySep 23, 2026Material Fragmentation

  It was reported that during a da Vinci-assisted cholecystectomy procedure, the Permanent Cautery Hook (PCH) instrument broke into pieces. One piece was retrieved and two plastic pieces were noted to be missing. The customer confirmed that intraoperative imaging was performed to look for the remaining two fragments. Hence, the procedure was completed with a delay of approximately 2 hours.

  Patient problems: Foreign Body In Patient

  MAUDE report 50873400 ↗
• InjurySep 23, 2026Energy Output Problem

  It was reported that during a da Vinci-assisted right hemicolectomy procedure, while using the Permanent Cautery Hook instrument, the surgeon stated the tearing effect was more pronounced than expected. The customer reports that the E-200 generator was already replaced. The customer also reports that the surgeon never perceived a clear improvement, even after the generator was replaced. The surgeon therefore began using scissors more and the hook less. A Technical Support Engineer (TSE) reviewed the system logs and found no relevant errors. The procedure is completing robotically, as expected, with less than 15 minutes delay.Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained the following additional information: The target tissue was colon loops. There was no adverse effect to the tissue or unexpected tissue removal, but there was bleeding of less than 1cc due to the event which was controlled with cautery from a bipolar instrument. There was no concern for post-operative or long-term complications. The customer noted that the instrument is not available to return as they continued to use it after solving the problem by adjusting the energy effect. No

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50870874 ↗
• MalfunctionSep 22, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860882 ↗
• MalfunctionSep 22, 2026Break

  It was reported that during central processing, 8mm Permanent Cautery Hook instrument was observed broken.There was no report of patient involvement or patient injury.

  Patient problems: Insufficient Information

  MAUDE report 50850396 ↗
• MalfunctionSep 18, 2026Thermal Decomposition of Device

  It was reported that during a da Vinci-assisted surgical procedure, the staff noticed smoke coming from the plastic housing unit of the Permanent Cautery Hook instrument. Staff clearly noted smoke was coming from the housing unit and not the tip of the instrument. They removed the instrument and they said you could smell burnt plastic. The procedure was completed with no reported injury.ISI followed up with the initial reporter and obtained the following additional information: No arcing observed during the last procedure in which the instrument was used. There was no injury to the patient. Smoke was not coming from the tip. The product has already been shipped back to ISI for evaluation. No photographic images of the instrument available for review.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50813716 ↗
• MalfunctionAug 24, 2026Thermal Decomposition of Device

  It was reported that during a da Vinci-assisted surgical procedure, the Permanent Cautery Hook started to smoke at the tip of the instrument. The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50414691 ↗