Kii Sleeve CFS03Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607915123130), received between Mar 1, 2017 and Mar 1, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionMar 1, 2017Break; Break

  DIAGNOSTIC LAPAROSCOPIC + BIOPSY - "A 5X100MM OBTURATOR WAS INSERTED INTO A 5X75MM ADVANCED FIXATION SLEEVE. MR. (B)(6) USED THE TROCAR WITH THE WRONG OBTURATOR. THE OBTURATOR WAS BENT AT THE POINT WHICH IT CAME OUT OF THE CANNULA. MR. (B)(6) HAD BEEN PASSED THE WRONG LENGTH OBTURATOR. PRODUCT CFS03 IS NOT AVAILABLE ANYMORE FOR EVALUATION. HOWEVER THE HOSPITAL HAS RETURNED BY MISTAKE THE 3 FOLLOWING DEVICES USED IN THIS PROCEDURE: 1 EA CTB73 BATCH 1245782, 1EA CTS22 BATCH 1246103, 1EA CFF73 BATCH 1245796. RGA60676923 HAS BEEN UPDATED WITH REMOVAL OF CFS03 AND ADDITION OF THE ABOVE 3 PRODUCTS. " PATIENT STATUS - FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370902 ↗