Kii Fios First Entry CTF04Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607915123567), received between Apr 14, 2017 and Apr 14, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Bent” (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.

• MalfunctionApr 14, 2017Bent; Bent

  PROCEDURE PERFORMED: LAP GASTRIC SLEEVE (NON-ROBOTIC). INCIDENT DESCRIPTION: THE TROCAR BENT DURING FIRST ENTRY WHILE USING THE FIOS TECHNIQUE, THE SALES REPS WAS INFORMED THAT THE OBTURATOR WAS INSIDE THE CANNULA WHEN THE MALFUNCTION OCCURRED. APPLIED MEDICAL RECEIVED ADDITIONAL INFORMATION VIA EMAIL FROM TERRITORY MANAGER ON (B)(4) 2017: THE DR. WAS PERFORMING A LAP GASTRIC SLEEVE (NON-ROBOTIC) AND USING THE CTF04 FOR THE FIOS FIRST ENTRY TECHNIQUE. AS HE WAS INSERTING THE TROCAR, IT BENT IN HALF (OBTURATOR STILL INSIDE). THE BENT TROCAR WAS REMOVED AND A NEW ONE WAS USED. NO PARTS WERE LEFT INSIDE THE PATIENT AND NO INJURY OCCURRED. MEDWATCH RECEIVED 12APR2017 - EVENT DESCRIPTION: DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, THE OBTURATOR WITH SLEEVE BENT DURING INSERTION INTO THE PATIENT. TYPE OF INTERVENTION: AN ADDITIONAL TROCAR WAS USED. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6494201 ↗