NA 03.615.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034715230), received between Aug 12, 2022 and Aug 12, 2022 — classified as 2 malfunctions.

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

• MalfunctionAug 12, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT THE GREEN HANDLE TO ANGLE THE BLADES OF THE INSIGHT RETRACTOR DOESN'T FIT THE TOP OF THE BLADES. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE HAND F/RETRAC. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15216215 ↗
• MalfunctionAug 12, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT THE GREEN HANDLE TO ANGLE THE BLADES OF THE INSIGHT RETRACTOR DOESN'T FIT THE TOP OF THE BLADES. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED THERE WAS NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1) HAND F/RETRAC. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15216212 ↗