EndoWrist 48630BRecalls & reported problems
Intuitive Surgical, Inc. · STAPLER 30 RELOAD · Class 2 · Implant
All models of EndoWrist (62)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886874112830), received between Dec 22, 2021 and Nov 9, 2023 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Open or Close” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Open or Close1
- Firing Problem1
- Misfire1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Tissue Injury1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 9, 2023Firing Problem; Firing Problem
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Insufficient Information
MAUDE report 18107749 ↗MalfunctionMay 27, 2023Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CURVED TIP STAPLER 30 COMPLETED CLAMPING; HOWEVER, STAPLING WAS INCOMPLETE. A SIMILAR BACKUP DA VINCI INSTRUMENT WAS USED TO CONTINUE WITH THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17015750 ↗InjuryDec 22, 2021Misfire; Misfire
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Unspecified Tissue Injury
MAUDE report 13060842 ↗
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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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