EndoWrist 41445GRecalls & reported problems
Intuitive Surgical, Inc. · STAPLER 45 RELOAD · Class 2 · Implant
All models of EndoWrist (62)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886874112809), received between Jun 6, 2023 and Jun 6, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “No Device Output” (1 report).
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
Device problems
- No Device Output1
- Visual Prompts will not Clear1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 6, 2023No Device Output; Visual Prompts will not Clear; No Device Output; Visual Prompts will not Clear
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, A ¿RESTORE MOTOR PACK TO CONTROL BOX CONNECTION¿ ERROR OCCURRED SEVERAL TIMES. THE CUSTOMER EXCHANGED OUT THE SUREFORM 45 STAPLER INSTRUMENT AND CABLE, BUT RECOGNITION ERRORS (NO ICB BLUE LED, TURNED ON RED LED, ETC.) OCCURRED. THE CUSTOMER COULD NOT COMPLETE THE GIVEN TROUBLESHOOTING STEPS AS IT WOULD TAKE A LONG TIME TO RESOLVE THE ISSUE. THE USER COULD NOT USE THE RELOAD TO FIRE. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER SUSPECTED THAT THERE IS A PROBLEM WITH THE I&A (STAPLER INSTRUMENT, RELOAD) BUT WAS UNSURE EXACTLY WHICH PART HAD AN ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17067493 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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