Kii Shielded Bladed Dual Pack CTB10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607915124007), received between Mar 9, 2017 and Aug 8, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 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 8, 2022Break; Break

  PROCEDURE PERFORMED: BARIATRIC PATIENT. EVENT DESCRIPTION: BREAKAGE OF THE TROCAR SLEEVE AFTER PLACEMENT AND DURING INSERTION AND HANDLING WITH THE INSTRUMENTS. BROKEN PIECE RECOVERED FROM THE PATIENT BY ANOTHER TROCAR. EXTENDED PROCEDURE INTERVENTION: BROKEN PIECE RECOVERED FROM THE PATIENT BY ANOTHER TROCAR. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15189011 ↗
• MalfunctionMar 9, 2017Break; Break

  LAP CHOLECYSTECTOMY: "CONSULTANT PLACED TROCAR CORRECTLY AND TROCAR WAS FULLY FUNCTIONING THROUGHOUT OPERATION. WHEN THE CONSULTANT REMOTED THE TROCAR AT THE END OF THE PROCEDURE THE TROCAR BROKE IN THE MIDDLE. IT IS THOUGHT NO PARTS WERE LEFT UNINTENTIONALLY IN THE PATIENT AND THE TROCAR IS COMPLETE. PLEASE CONTACT THE LEAD NURSE VIA EMAIL TO ARRANGE COLLECTION OF THE TROCAR. " PATIENT STATUS- OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6393666 ↗