Kii Fios First Entry CTF34Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607915124229), received between Dec 15, 2016 and Mar 16, 2023 — classified as 3 malfunctions.

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

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2023Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: BARIATRIC SURGERY. EVENT DESCRIPTION: SURGEON USES THIS DEVICE INSERT INTO AN INCISION. SUDDENLY, THE TIP OF OBTURATOR WAS BROKEN. THERE IS NO IMPACT TO PATIENT. USER REPLACE WITH CTR71 TO COMPLETE THIS SURGERY. THERE IS NO OTHER INSTRUMENTS TO EFFECT THIS EVENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 07MAR2023 FROM DISTRIBUTOR: THE TIP OF THE OBTURATOR BROKE. THERE WAS ONE CANNULA INSERTED USING THE OBTURATOR PRIOR TO THE INCIDENT. NO PIECES FELL INTO THE PATIENT. THE TROCAR WAS INSERTED BY ROTATING IN AN ALTERNATING CLOCKWISE AND COUNTERCLOCKWISE DIRECTION. THIS WAS NOT A ROBOTIC CASE. INTERVENTION: USER REPLACE WITH CTR71 TO COMPLETE THIS SURGERY. PATIENT STATUS: FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16558769 ↗
• MalfunctionJan 9, 2023Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: BARIATRIC SURGERY EVENT DESCRIPTION: SURGEON USES THIS DEVICE INSERT INTO AN INCISION. SUDDENLY, THE TIP OF OBTURATOR WAS BROKEN. THERE IS NO IMPACT TO PATIENT. PRODUCT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON (B)(6)2023 FROM DISTRIBUTOR: THE BEND/BREAK OCCURRED AT THE TIP. WHEN ASKED HOW MANY CANNULAS WERE INSERTED USING THE OBTURATOR PRIOR TO THE INCIDENT, CUSTOMER RESPONDED "IT JUST USED WITH ITSELF CANNULA." NO PIECES FELL INTO THE PATIENT. "THIS UNIT HAVE NOT INSERT THROUGH PATIENT'S PERITONEUM, AND THEN USER FOUND THAT THE TIP OF OBTURATOR WAS BROKEN. WHEN BEING INSERTED, THE TROCAR WAS "ROTATED IN CLOCKWISE." NO DIFFICULTY EXPERIENCED DURING INSERTION. NO THIS WAS NOT A ROBOTIC CASE. INTERVENTION: USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. PATIENT STATUS: FINE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16127161 ↗
• MalfunctionDec 15, 2016Positioning Problem; Positioning Problem

  LAPAROSCOPIC CYSTECTOMY - "THE HANDLE OF OBTURATOR FITS LOOSE INTO THE SLEEVE. WAS NOT USED FOR PROCEDURE." ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR VIA EMAIL ON NOVEMBER 23, 2016: "THE OBTURATOR FIT LOOSELY INTO CANNULA IT WAS PACKAGED WITH. WAS NOT USED WITH ADDITIONAL SLEEVES." PATIENT STATUS - UNK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6179679 ↗