Kii Shielded Bladed Dual Pack CTB14Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607915123949), received between Oct 2, 2017 and Oct 2, 2017 — classified as 1 malfunction.

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

• MalfunctionOct 2, 2017Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: LAPAROSCOPIC HERNIA REPAIR. EVENT DESCRIPTION: I WAS IN ATTENDANCE AT THE TIME OF THE FOLLOWING EVENT. APPLIED MEDICAL ARE CURRENTLY EVALUATING TROCARS IN THIS HOSPITAL AS PART OF ANEURIN BEVAN TRUST. THE PRIMARY PORT WAS PLACED, BY THE SURGEON MR [NAME]. USING INTERNAL VISION CONTROLLED BY MR [NAME], HIS REGISTRAR MS [NAME] ATTEMPTED TO PLACE A SECONDARY 5 MM PORT (CTB14). THE INITIAL 'CLICK' WAS AUDIBLE ON ENTRY WHICH SUGGESTED THE BLADE WAS ENGAGED,. SHE PROCEEDED TO CUT THROUGH ABDOMINAL TISSUE AND THE PORT CAME IN TO VIEW. THE BLADE WAS CLEARLY VISABLE. MS [NAME] SUGGESTED SHE HAD HEARD THE SECONDARY 'CLICK' BUT THE BLADE HAD NOT RETRACTED AS IT SHOULD HAVE DONE. IT WAS OBVIOUS THAT THOUGH NOT CUTTING ANY TISSUE WAS STILL EXPOSED. MS [NAME] REMOVED THE BLADED OBTURATOR FROM THE CANNULA AND CONTINUED WITH THE PROCEDURE. NO INJURY TO THE PATIENT WAS CAUSED AS A RESULT OF THE EXPOSED BLADE. THE BLADED OBTURATOR WAS COLLECTED FOLLOWING THE PROCEDURE, AND IS BEING KEPT AT THE THEATRE MANAGERS OFFICE AWAITING COLLECTION. TYPE OF INTERVENTION: SURGEON REMOVED THE BLADED OBTURATOR FROM THE CANNULA AND CONTINUED WITH THE PROCEDURE. PATIENT STATUS: DID A PATIENT INJ

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6909019 ↗