WECK VISTA 470359Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886874112526), received between Feb 21, 2021 and Dec 15, 2022 — 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 18, 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.

• MalfunctionDec 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, A PIECE OF PLASTIC BROKE OFF OF THE OPTICAL OBTURATOR AND FELL INTO THE OPTICAL TIP OF THE OBTURATOR WHEN THE TROCAR WAS BEING PLACED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON CONFIRMED THAT IT OCCURRED DURING HIS CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2022. THE SURGEON CORRECTED THE INFORMATION THAT WAS INITIALLY PROVIDED AND STATED THAT THERE WERE NO FRAGMENTS THAT FELL INTO THE PATIENT AND THAT THE PIECE THAT FELL WAS IN BETWEEN THE VIEW OF THE SCOPE LENS AND THE OPTICAL TIP OF THE OBTURATOR. THERE WAS NO PATIENT HARM DUE TO THE ISSUE AND THERE WERE NO FRAGMENTS THAT NEEDED TO BE RETRIEVED FROM THE PATIENT. THE 8MM OPTICAL OBTURATOR WAS REMOVED AND REPLACED WITH A REGULAR 5MM OPTICAL OBTURATOR AND THEN THEY REPLACED THAT WITH A REGULAR 8MM OBTURATOR WITHOUT AN OPTIC VIEW. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO PATIENT INJURY. NO IMAGES OR PATIENT DEMOGRAPHICS WERE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15991740 ↗
• InjuryFeb 21, 2021Detachment 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 11356880 ↗