EndoWrist 470545Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886874113806), received between Apr 28, 2020 and May 28, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION SURGICAL PROCEDURE, A CURVED-TIP STAPLER INSTRUMENT DIDN'T ENGAGE WITH THE SYSTEM ARM. WHILE TROUBLESHOOTING, THE SCRUB TECH WAS NOT ABLE TO OPEN JAWS ON THE STAPLER TO REPLACE THE RELOAD. THEY HAD TO OPEN A NEW INSTRUMENT DUE TO THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON 3-AUG-2021 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SHE STATED THE STAPLER WAS NOT STUCK ON THE PATIENT TISSUE AND THE STAPLER RELEASE KIT (SRK) WAS NEVER USED. THE STAPLER WAS NOT ENGAGING. AFTER THIS, THE TECH WAS ABLE TO OPEN THE JAWS TO REMOVE THE RELOAD. THEY USED A BACK UP STAPLER TO CONTINUE WITH THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015910 ↗
• InjuryMay 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PULMONARY WEDGE RESECTION PROCEDURE, A STAPLER 45 INSTRUMENT BROKE INSIDE OF A PATIENT. THE SITE'S ROBOTIC COORDINATOR (ROCO) CALLED IN THE ISSUE TO TECHNICAL SUPPORT AFTER THE PROCEDURE HAD BEEN COMPLETED. THE ROCO REPORTED THAT THEY WERE ABLE TO RETRIEVE ALL PARTS. THE TECHNICAL SUPPORT ENGINEER (TSE) VIEWED SYSTEM EVENT LOGS FOR THE REPORTED PROCEDURE, BUT FOUND NO RELATED ENTRIES. THE ROCO STATED THEY WERE ABLE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16928188 ↗
• InjuryApr 28, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL PANCREATECTOMY AND SPLENECTOMY SURGICAL PROCEDURE ON A PETITE (B)(6) LBS, (B)(6)-YEAR-OLD, CAUCASIAN WOMAN, THE SURGEON WAS USING THE CURVED TIP STAPLER 45 INSTRUMENT WITH A BLUE STAPLER 45 RELOAD, AND THE INSTRUMENT GOT STUCK. AT THAT TIME, THE CURVED TIP STAPLER 45 INSTRUMENT "DID ITS OWN THING" AND MOVED UNEXPECTEDLY. THE SITE HAD TO USE THE STAPLER RELEASE KEY TO OPEN THE JAWS OF THE INSTRUMENT. THERE WAS A POOL OF BLOOD, AND IT IS UNKNOWN IF THERE WAS ANY INJURY. ON (B)(4) 2020, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S CIRCULATORY NURSE AT (B)(6), AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL PANCREATECTOMY AND SPLENECTOMY SURGICAL PROCEDURE ON A PETITE (B)(6) LBS., (B)(6)-YEAR-OLD, CAUCASIAN WOMAN, THE SURGEON WAS USING THE CURVED TIP STAPLER 45 INSTRUMENT WITH A BLUE STAPLER 45 RELOAD, AND THE INSTRUMENT GOT STUCK. THE NURSE STATED THIS WAS THE FIRST FIRE OF THE PROCEDURE WITH THE CURVED TIP STAPLER 45 INSTRUMENT. THE NURSE INDICATED THAT SHE IS NOT SURE IF ANYONE BUMPED THE ARMS; HOWEVER, THE JAWS OF THE CURVED TIP STAPLE

  Patient problems: Injury

  MAUDE report 10008216 ↗