None 370893Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00886874110218), received between Feb 24, 2022 and Mar 8, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2022Material Fragmentation; Material Fragmentation

  THE ENDOSCOPE WAS RETURNED WITH NO REPORTED COMPLAINT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) COMPLETED CUSTOMER FOLLOW UP AND OBTAINED THE FOLLOWING INFORMATION: THE CUSTOMER EXPLAINED HE COULD NOT PROVIDE FURTHER DETAILS REGARDING THE ISSUE WITH THE SCOPE. HOWEVER, IT WAS CONFIRMED THAT AS SOON AS THE ISSUE WAS IDENTIFIED THE SITE SWAPPED TO BACK-UP SCOPE AND COMPLETED THE PROCEDURE WITH NO REPORT OF PATIENT INJURY. THERE WAS NO INDICATION THAT FRAGMENTS BROKE OFF THE SCOPE DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 13695610 ↗
• MalfunctionFeb 26, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT PRIOR TO A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 30 DEGREE ENDOSCOPE WAS FOUND TO HAVE FOGGING ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS IDENTIFIED PRIOR TO STARTING PROCEDURE, SO THE PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13614833 ↗
• MalfunctionFeb 24, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PRIOR TO STARTING (PRE ANESTHESIA) A DA VINCI ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE ENDOSCOPE APPEARED TO HAVE A DARK AND CLOUDY IMAGE. THE PROCEDURE WAS COMPLETED WITH A SPARE ENDOSCOPE, WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13596593 ↗
• MalfunctionFeb 24, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THERE WAS A FOGGING ISSUE. THE PROCEDURE WAS COMPLETED WITH A BACK-UP ENDOSCOPE. THERE WAS NO REPORTED INJURY NOR DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13596111 ↗