Kii Shielded Bladed Dual Pack CFB12Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607915124106), received between May 13, 2019 and Jun 23, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC SALPINGO OOPHRECTOMY. EVENT DESCRIPTION: LAPAROSCOPIC PROCEDURE UNDERWAY - ALL PORTS INSITU MR [NAME REDACTED] DRAINED A CYST WITH A LAPAROSCOPIC NEEDLE VIA A PORT - THE NEEDLE WAS THEN REMOVED. THE LAPAROSCOPIC SUCTION WAS THEN INSERTED, INSIDE THE CAVITY THE SEAL WAS IDENTIFIED NEXT TO THE SUCTION TIP. THE PLASTIC SEAL WAS RETRIEVED FROM INSIDE THE ABDOMEN WITH THE LAPAROSCOPIC GRASPERS. PLASTIC SEAL STORED IN POT. OPENED AN UNUSED PORT TO CONFIRM ITEM REMOVED FROM PATIENTS ABDOMEN WAS ALSO A SEAL. ON THE SEAL 9 SMALL PLASTIC ¿FLAPS¿ SHOULD BE PRESENT - HOWEVER IS WAS FOUND THAT ONE HAD BROKEN OFF. REPORTED TO MHRA (B)(6) 2023 YELLOW CARD REPORT ID: 2023/006/013/501/005. TYPE OF INTERVENTION: OPENED AN UNUSED PORT TO CONFIRM ITEM REMOVED FROM PATIENTS ABDOMEN WAS ALSO A SEAL. PATIENT STATUS: NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17192706 ↗
• MalfunctionFeb 15, 2023Retraction Problem; Fail-Safe Did Not Operate; Retraction Problem; Fail-Safe Did Not Operate

  PROCEDURE PERFORMED: EXPLORATORY LAPAROSCOPY. EVENT DESCRIPTION: [TRANSLATION] WE HAVE EXPERIENCED AN INCIDENT WITH A LAPAROSCOPIC TROCAR (REF: (B)(4), LOT: 1464276) WHOSE BLADE DID NOT RETRACT AT THE TIME OF THE TEST BEFORE THE TROCAR WAS INSERTED. THE DEVICE WAS KEPT FOR EXPERTISE, IF NEEDED. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REPRESENTATIVE ON 15FEB23 VIA EMAIL: IT CAN BE CONFIRMED THAT THERE WAS NO PROBLEM WITH THE PATIENT, AS THE DEVICE WAS NOT USED. IT WAS THE NURSE WHO REPORTEDLY SAID THE DEVICE WAS NOT WORKING. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REPRESENTATIVE ON 3MAR23 VIA EMAIL: [TRANSLATION] THE SURGEON CAN'T REMEMBER IF THE RED INDICATOR/BLADE REMAIN EXPOSED AFTER INSERTION AND THE DEVICE HAS ALREADY BEEN RETURNED PATIENT STATUS: NO PROBLEM WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16380346 ↗
• MalfunctionMay 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: KYSTECTOMY LAPAROSCOPY. EVENT DESCRIPTION: DURING A LAPAROSCOPY WITH DR. [NAME], A GAS LEAK IN THE TROCAR WAS FOUND DURING THE PROCEDURE. THE SURGEON THEREFORE CHANGED HIS TROCAR, THE INTERVENTION WAS ABLE TO CONTINUE, BUT THE OPERATING TEAM REALIZED THAT PART OF THE PREVIOUS TROCARS FELL INTO THE ABDOMEN. IT SEEMS TO ME THAT IT IS A SEAL, WHICH WOULD EXPLAIN THIS LEAK. THE PHARMACIST THINK IT IS THE SEAL. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP BY EMAIL ON 23APR19: THIS IS THE FIRST SEAL THE PART OF THE TROCAR THAT FELL IN THE ABDOMEN WAS RETRIEVED FROM THE PATIENT. AN ENTIRE COMPONENT FELL OUT. 2 PHOTOS ARE ATTACHED TO THE COMPLAINT. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP BY EMAIL ON 25APR19: DATE OF INCIDENT WAS 18APR19 TYPE OF INTERVENTION: CHANGE OF DEVICE. PATIENT STATUS: OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8603775 ↗