Kii Shielded Bladed Dual Pack CTB12Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00607915123529), received between Oct 19, 2016 and Apr 15, 2024 — classified as 1 injury, 5 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2024Device-Device Incompatibility; Physical Resistance/Sticking; Device-Device Incompatibility; Physical Resistance/Sticking

  PROCEDURE PERFORMED: LAP CHOLECYSTECTOMY. EVENT DESCRIPTION: I RECEIVED A CALL FROM THE PHARMACIST, FOLLOWED BY THE DOCUMENT OF AN INCIDENT OCCURRED THIS WEDNESDAY (B)(6) WITH ONE OF OUR EPIX UNIVERSAL CLIP APPLIER AND/OR/WITH ONE OF OUR KII 5MM TROCAR. THE PROBLEM HAS BEEN DESCRIBED AS: " SLIDING PROBLEM OF THE CLIP APPLIER INTO THE 5MM TROCAR". AS A RESULT OF THE EVENT A INJURY HAS BEEN MENTIONED REGARDING A LIVER WOUND. APPARENTLY, THEY PLACED THE 5MM KII TROCAR AND THE EPIX UNIVERSAL CLIP APPLIER ASIDE AND THEY OPENED A NEW 5MM KII TROCAR AND A NEW EPIX UNIVERSAL CLIP APPLIER. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON (B)(6) 2024. PATIENT STATUS IS OK. THE NURSE TOLD THAT THE SURGEON INSERTED THE CLIP APPLIER (LOT 1501033) INTO THE 5MM KII TROCAR (CTB12 LOT 1512234). HE HAD SOME DIFFICULTY TO INSERT INTO IT AND FORCED TO PENETRATE THE CAVITY. BY FORCING, HE DID A LIVER INJURY. HE DID HEMOSTASIS ON THE LIVER AND THE PATIENT IS OK. THEN, HE TOOK THE CLIP APPLIER OUT AND PLACED IT ASIDE. HE TOOK THE TROCAR OUT AND OPENED A NEW CLIP APPLIER (LOT 1496065) AND A NEW 5MM KII TROCAR (CTB03 LOT 1494707). ACCORDING TO THE SURGEON, HE THINK THE DEFAULT COMES FROM

  Patient problems: Liver Laceration(s); Needle Stick/Puncture

  MAUDE report 19112545 ↗
• MalfunctionJan 23, 2018Break; Break

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: DURING A SURGICAL PROCEDURE IDENTIFICATION BY OPERATOR OF A SHARP PIECE ABOUT 5MM IN THE PATIENT'S ABDOMEN. ADDITIONAL INFORMATION RECEIVED FROM TERRITORY MANAGER ON 11 JANUARY 2018: FOR THE INCIDENT WITH THE TROCART THERE WAS A BLUE PIECE OF THE SLEEVE IN THE ABDOMINAL WALL . THE SURGEON MAKE HIS OPERATION SUCCESSFULLY BUT ONE NURSE FIND THIS BLUE PIECE WHEN THEY GET OUT THE TROCART. PICTURE OF THE "SHARP PIECE" IS NOT AVAILABLE. PATIENT STATUS: THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7214271 ↗
• MalfunctionSep 19, 2017Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: LAPAROSCOPY EVENT DESCRIPTION: THE TROCAR SPIKE OF 5 MM, DEFECT = IMPOSSIBLE TO TRIGGER THE ISSUE OF THE KNIFE, THE CURSOR DOES NOT HOLD. CLINICAL CONSEQUENCES: ENTRY INTO FORCE ... ORIGINAL: LA PIQUE DU TROCARD DE 5 MM, DÉFAUT = IMPOSSIBLE D'ENCLENCHER L'ISSUE DU COUTEAU, LE CURSEUR NE TIENT PAS. CONSÉQUENCES CLINIQUES : ENTRÉE EN FORCE... ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM SALES REPRESENTATIVE ON 15AUG2017: ADDITIONAL QUESTIONS WERE ASKED TO THE OR-TEAM, BUT IT'S A VERY OLD CASE AND NOBODY SEEMS TO BE ABLE TO ANSWER THE QUESTIONS. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM SALES REPRESENTATIVE ON 21AUG2017: BLADE FORCEFULLY EXPOSED DURING THE FORCE INTRODUCTION OF THE TROCAR BECAUSE THE CURSOR DID NOT REMAIN ENGAGED. NO PIECE FALL INTO THE PATIENT. THE NON-CONFORMANCE WAS IDENTIFIED AT THE BEGINNING OF THE PROCEDURE. RISK TAKING SINCE THERE IS NO SAFETY OF RETRACTION OF THE BLADE TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6877798 ↗
• MalfunctionApr 3, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: APPENDECTOMY - DURING APPENDECTOMY UNDER LAPAROSCOPY, A PIECE OF PLASTIC WAS FOUND IN THE ABDOMINAL CAVITY OF THE PATIENT. THIS PLASTIC HAS THE SAME TEXTURE OF THE VALVE OF THE TROCAR. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP ON 23 MARCH 2017: THE CUSTOMER IS REFERRING TO THE BLACK SEAL. PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6455170 ↗
• MalfunctionMar 2, 2017Component Incompatible; Component Incompatible

  PROCEDURE PERFORMED UNKNOWN - "DURING USE OF THE DEVICE IT WAS IMPOSSIBLE TO DISENGAGE THE SHIELD." PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6372214 ↗
• MalfunctionOct 19, 2016Bent; Bent

  LAP CHOLE - "TROCAR BENT." ADDITIONAL INFORMATION RECEIVED VIA EMAIL 20 JUNE 2016: WHAT PROCEDURE WAS BEING PERFORMED? LAP CHOLE. WHAT IS THE PATIENT?S STATUS? N/A-THIS TROCAR WAS NOT USED ON PATIENT. AT WHAT POINT IN THE PROCEDURE WAS THE NON-CONFORMANCE IDENTIFIED? BEFORE ENTRY/INTRODUCTION ? WHEN SCRUB NURSE ATTEMPTED TO PLACE OBTURATOR INTO CANNULA, IT WOULD NOT FIT, AS THE BLADE WAS BENT. WAS THE TROCAR REPLACED? YES. DID THE TROCAR CRACK AT ALL? UNKNOWN." PATIENT STATUS - "THIS TROCAR WAS NOT USED ON THE PATIENT." TYPE OF INTERVENTION - UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 6038881 ↗