Kii® OPTICAL ACCESS SYSTEM CTR74Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607915123697), received between Oct 11, 2017 and Oct 11, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UNKNOWN EVENT DESCRIPTION: "NEAR THE END OF THE PROCEDURE, THE SURGICAL TEAM NOTICED A BLACK ITEM INSIDE THE PATIENT'S ABDOMEN. IT WAS RETRIEVED FROM INSIDE THE PATIENT WITH NO PATIENT HARM REPORTED. THROUGH INVESTIGATION BY THE HOSPITAL, IT WAS OBSERVED THAT A PIECE OF THE INSIDE OF THE TROCAR (BLACK RUBBER) HAD BROKEN OFF. PICTURES ATTACHED TO ASSOCIATED EMAIL. " TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: "NO ADVERSE PATIENT OUTCOME."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6941047 ↗