EntryGuide 430022Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886874113509), received between Mar 15, 2023 and May 25, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE ENTRY GUIDE KIT WAS SEPARATED AND COULD NOT BE USED. A BACKUP KIT WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITY. THE ISSUE WAS IDENTIFIED PRIOR TO PORT PLACEMENT. THE CUSTOMER CONFIRMED THAT NO FRAGMENT FELL INSIDE OF THE PATIENT. THERE WAS NO PATIENT INJURY/HARM. PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE WERE NOT AVAILABLE FOR ISI REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17000802 ↗
• InjuryMar 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 16550361 ↗