Kii Shielded Bladed Access System CFB33Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00607915119843), received between May 3, 2016 and Dec 9, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2025Failure to Cycle; Failure to Cycle

  PROCEDURE PERFORMED: HYSTERECTOMY. EVENT DESCRIPTION: DURING INSERTION, THE TROCAR DID NOT ENGAGE. IT WAS NECESSARY TO CONVERT THE PROCEDURE TO OPEN SURGERY DUE TO PERFORATION OF A LARGE BLOOD VESSEL, REQUIRING THE INTERVENTION OF THE VASCULAR TEAM. AFTER CONVERSION TO OPEN SURGERY, THE PATIENT REMAINED IN RECOVERY IN THE UTI, DUE TO BLEEDING, REQUIRING BLOOD TRANSFUSION. THE TROCAR WAS DISCARDED DUE TO CONTAMINATION. ADDITIONAL INFORMATION PROVIDED BY [DISTRIBUTOR] ON 10FEB2026 VIA EMAIL: UNFORTUNATELY, THE HOSPITAL IS NOT RESPONDING TO MESSAGES BECAUSE WE QUESTIONED THE USE OF A PRODUCT THAT WAS ALREADY EXPIRED. ADDITIONAL INFORMATION PROVIDED BY [DISTRIBUTOR] ON 11FEB2026 VIA EMAIL: YES, THE ABDOMEN WAS INSUFFLATED AT THE TIME THE EVENT UNIT WAS INSERTED. WE DON'T HAVE KNOWLEDGE IF THEY WERE ABLE TO ACTIVATE THE DEVICE SO THE RED INDICATOR WAS SHOWING BEFORE USE. WE DON'T HAVE KNOWLEDGE IF THE SHIELD OF THE EVENT UNIT DEPLOYED UPON ENTERING ABDOMEN. ¿UTI¿ STANDS FOR ICU. INTERVENTION: CONVERTED TO OPEN SURGERY. PATIENT STATUS: AFTER CONVERSION TO OPEN SURGERY, THE PATIENT REMAINED IN RECOVERY IN THE UTI, DUE TO BLEEDING, REQUIRING BLOOD TRANSFUSION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23759998 ↗
• MalfunctionJul 22, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: TOTAL LAPAROSCOPIC HYSTERECTOMY. EVENT DESCRIPTION: (NAME REDACTED) WAS THE OPERATING SURGEON, PERFORMING A TOTAL LAPAROSCOPIC HYSTERECTOMY. (NAME REDACTED) REPORTED THAT IS WAS A COMPLEX CASE WITH A NUMBER OF ADHESIONS. THE TROCAR WAS POSITIONED IN THE SUPRA PUBIC REGION. (NAME REDACTED) USED A LAPAROSCOPIC RETRIEVAL BAG TO REMOVE THE OVARIES. (NAME REDACTED) REMOVED THE TROCAR TO EXTRACT THE OVARIES, AND THEN REPLACED THE TROCAR IN THE SAME INCISION TO CONTINUE THE PROCEDURE. A COLORECTAL CONSULTANT SUPPORTED THE CASE, DUE TO BOWEL ADHESIONS. I HAVE ASKED FOR THE NAME OF THE COLORECTAL SURGEON AND WILL REPORT BACK. TOWARDS THE END OF THE CASE, (NAME REDACTED) WAS MAKING A FINAL OBSERVATION OF THE ABDOMINAL AREA WITH THE SCOPE, BEFORE FINISHING THE PROCEDURE. IT WAS AT THIS POINT THAT (NAME REDACTED) NOTICED THE DAMAGE TO THE END OF THE CANNULA. (NAME REDACTED) SPENT APPROXIMATELY ONE HOUR TO LOCATE THE MISSING PIECES, AND THESE WERE FOUND IN THE DRAPES AND ON THE FLOOR. (NAME REDACTED) REPORTED THAT NO PIECES WERE LEFT IN THE PATIENT'S ABDOMEN. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 04JULY25: RETRIEVAL BAG USED: [COMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569570 ↗
• MalfunctionDec 2, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC REMOVAL OF LEFT OVARIAN CYST. EVENT DESCRIPTION: DURING REMOVAL OF SPECIMEN WITH A RETRIEVAL BAG IT WAS NOTICED ON THE SCREEN THAT THE TROCAR WAS BROKEN AT THE TIP. BITS OF THE TROCAR HAD BROKEN OFF. ONCE THE TROCAR HAD BEEN REMOVED ALL THE PIECES MADE UP THE TROCAR. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 18NOV24: PATIENT STATUS IS UNKNOWN AT THE TIME OF REPORTING. THE TM STATED ' I¿M NOT SURE HOW I CAN FIND THIS OUT IF THE THEATRE STAFF DON¿T HAVE THIS ANSWER. THE HOSPITAL DID REPORT THIS FROM THEIR END AS WELL. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 20NOV24: THE TM STATED THAT THE THEATRE TEAM WERE NOT AWARE OF OR DID NOT STATE THERE WAS PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 16DEC24: THE TROCAR WAS INSERTED ' WITH ROTATION WHILE IN ADVANCING IN THE CAVITY' AND THERE WAS NO DIFFICULTY DURING INSERTION. THE TROCAR WAS NOT USED WITH A ROBOT. IT WAS CONFIRMED THE ONLY INSTRUMENT THAT WAS INSIDE OF THE CANNULA AT THE TIME OF THE INCIDENT WAS A SPECIMEN BAG. REGARDING PATIENT ' NO VISIBLE INJURY NOTED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20826747 ↗
• MalfunctionDec 14, 2022Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: [TRANSLATION] THE SERVICE DECLARES THAT: WHILE TAKING OUT THE SURGICAL PIECE THROUGH THE SLEEVE OF THIS TROCAR, AND PUTTING BACK THIS SLEEVE IN THE INCISION, THE SURGEON NOTICED THAT A PIECE WAS MISSING, THE SURGEON CHECKED THE WHOLE ABDOMINAL CAVITY AND CLEANED IT WITH 3L OF PHYSIOLOGICAL SERUM. ADDITIONAL INFORMATION FROM PRODUCT COMPLAINT FORM RECEIVED ON 06DEC2022: DURING SPECIMEN RETRIEVEMENT THROUGH THE CANULA A PIECE OF CANULA BROKE. TYPE OF INTERVENTION: THE SURGEON CHECKED THE WHOLE ABDOMINAL CAVITY AND CLEANED IT WITH 3L OF PHYSIOLOGICAL SERUM. PATIENT STATUS: OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15982810 ↗
• MalfunctionDec 15, 2021Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPY FOR ENDOMETRIOSIS WITH HYSTERECTOMY. EVENT DESCRIPTION: [TRANSLATION] THE LAPARO TROCARD BROKE IN THE PATIENT'S ABDOMEN. THE PIECE WAS FOUND (RISK OF LEAVING A FOREIGN BODY IN A PATIENT) PROTECTIVE MEASURES AND ACTIONS TAKEN: DECLARATION OF MEDICAL DEVICE VIGILANCE, MEDICAL DEVICE TAKEN TO THE PHARMACY ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 20DEC21: IT WAS A LAPAROSCOPY FOR ENDOMETRIOSIS WITH HYSTERECTOMY AND BILATERAL SALPINGECTOMY. WE HAD TO LOOK FOR THE MISSING PART OF THE TROCAR IN THE PATIENT'S ABDOMEN, WE TOOK AT LEAST 5 MIN TO FIND IT AND WE CHANGED THE TROCAR WITH A DIAM 10 TROCAR. IT IS A PART OF THE CANNULA AFTER THE BALLOON THAT IS IN THE PATIENT'S ABDOMEN. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 02FEB22: EVENT DATE : (B)(6) 2021. THERE IS NO MEMORY OF A "SHOCK" WITH ANOTHER INSTRUMENT DURING THE INTERVENTION. TYPE OF INTERVENTION: RETRIEVAL OF SEPARATED PART. PATIENT STATUS: WE HAD TO LOOK FOR THE MISSING PART OF THE TROCAR IN THE PATIENT'S ABDOMEN, WE TOOK AT LEAST 5 MIN TO FIND IT AND WE CHANGED THE TROCAR WITH A DIAM 10 TROCAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13014964 ↗
• MalfunctionAug 10, 2021Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAP OOPHORECTOMY/SALPINGECTOMY. EVENT DESCRIPTION: TRANSCRIPTION OF TELEPHONE CONVERSATION WITH [NAME] AT [HOSPITAL] (B)(6) 2021: EVENT INVOLVING CFB33 LOT 1405933, EXP 14-03-2024, OCCURRED YESTERDAY AFTERNOON. DURING USE, TIP OF CANNULA BROKE, SMALL FRAGMENTS IN THE ABDOMEN. ALL PIECES COULD NOT BE RECOVERED, SOME WERE REMOVED BUT NOT ALL. PROCEDURE WAS A LAP OOPHORECTOMY. PRODUCT IS AVAILABLE ¿ RETURN CAN BE ARRANGED. ADDITIONAL INFORMATION FROM MHRA INCIDENT REPORT RECEIVED VIA EMAIL 10AUG21: INCIDENT HAPPENED DURING A LAPAROSCOPIC SALPINGECTOMY. THE TIP OF ONE OF THE SINGLE USE CANNULAS USED TO GAIN ACCESS TO THE ABDOMEN APPEARED TO HAVE BROKEN AND FRAGMENTS OF PLASTIC WERE NOTICED IN THE ABDOMINAL CAVITY. THE PATIENT DOES NOT APPEAR TO HAVE SUFFERED ANY HARM. THE OPERATING SURGEON MANAGED TO RETRIEVE ALL VISIBLE BROKEN FRAGMENTS FROM ABDOMINAL CAVITY WITH FORCEPS. THE SURGEON IRRIGATED AND SUCTIONED THE ABDOMINAL CAVITY IN THE HOPE OF COLLECTING MORE FRAGMENTS BUT DURING THE PROCEDURE THE ANAESTHETIC CONSULTANT WAS CONCERNED AS THE PATIENT DID NOT TOLERATE THE PATIENT'S POSITION WELL OR THE INSUFFLATION OF CO2 GAS REQUIRED TO AID THE PROCEDURE. THE SURGEON

  Patient problems: Foreign Body In Patient

  MAUDE report 12304984 ↗
• MalfunctionJul 22, 2020Break; Break

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: WHEN INSTALLING THE TROCARS, THE END OF THE TROCAR BROKE WITH A CRACKING NOISE: TROCAR CRACKED SO VISIBLE. ADDITIONAL INFORMATION RECEIVED FROM FIELD IMPLEMENTATION TEAM MEMBER VIA EMAIL ON 16JUL2020: THE BREAK WAS A CLEAN BREAK. NO PIECE FELL INTO THE PATIENT. TYPE OF INTERVENTION: USE OF ANOTHER DEVICE. PATIENT STATUS: NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10309545 ↗
• MalfunctionJun 18, 2020Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: COLECTOMY. EVENT DESCRIPTION: USE OF A SINGLE-USE LAPAROSCOPIC TROCAR DURING A COLECTOMY. AT THE INTRODUCTION, THE END OF THE SLEEVE WAS BROKEN ON 2 CM BROKEN ELEMENT DETACHED IN THE WALL. FOUND IN DIRECT SIGHT. CURRENT STATE OF THE PATIENT: NONE BECAUSE PIECE RECOVERED. ACTIONS UNDERTAKEN IN THE CARE ESTABLISHMENT FOR PATIENT CARE: USE OF ANOTHER TROCAR TYPE OF INTERVENTION: USE OF ANOTHER TROCAR. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10168705 ↗
• MalfunctionJul 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP KYSTECTOMIE / LAP CYSTECTOMY. EVENT DESCRIPTION: THE NURSE REPORTED THAT WHEN THE SURGEON INSERTED A JOHANN FORCEPS WITH AN [NON-APPLIED RETRIEVAL BAG], IT WAS FIRST MORE DIFFICULT THAN USUAL ; ONE OF THE BLACK SEAL AND THE WHITE ONE FROM OUR TROCAR WERE SEPARATED FROM THE TROCAR ITSELF, FELT OUT OF THE TROCAR IN THE ABDOMINAL CAVITY, BUT NOT FREE AS THEY WERE AROUND THE CORD OF THIS [NON-APPLIED RETRIEVAL BAG]. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8827711 ↗
• MalfunctionAug 22, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAP ECTOPIC. EVENT DESCRIPTION: "SMALL PIECES OF PLASTIC/RUBBER FOUND IN PATIENTS ABDOMEN FOLLOWING INTRODUCTION OF A RETRIEVAL BAG DURING LAPAROSCOPIC SURGERY. ITEMS REMOVED FROM THE ABDOMEN, SEAL EXAMINED AND THE BITS APPEAR TO MATCH BROKEN AREAS ON THE SEAL. PATIENT INFORMED BY THE SURGEON. ITEMS RETAINED BY THE SCRUB NURSE." ADDITIONAL INFO RECEIVED FROM APPLIED TEAM MEMBER VIA EMAIL ON 27TH JULY 2017: "[SURGEON] WRAPPED [COMPETITOR'S] BAG AROUND JOHAN INSTRUMENT. [SCRUB SISTER] NOTICED THE BAG WAS NOT TIGHTLY WRAPPED AROUND THE INSTRUMENT WHEN INSERTING THE BAG. FORCE WAS USED TO INSERT BAG. [SCRUB SISTER] BELIEVES THIS IS WHAT CAUSED THE BITS OF RUBBER FROM THE DOUBLE DUCK BILL TO COME AWAY FROM THE SEAL HOUSING UNIT." PATIENT STATUS: NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6810291 ↗
• MalfunctionMay 19, 2016Break; Fracture; Break; Fracture

  VATS - VIDEO ASSISTED THORACOSCOPIC SURGERY - "TROCAR WAS INSERTED AND UTILIZED DURING CASE. UPON REMOVAL OF THE TROCAR, IT WAS DETERMINE THAT THE TIP HAD FRACTURED." TYPE OF INTERVENTION - "AREA WAS INSPECTED AND REVIEWED BY SURGEON BUT REMAINING MATERIAL COULD NOT BE SEEN." PATIENT STATUS - "STABLE UPON DISCHARGE FROM THE OPERATING ROOM."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5668046 ↗
• MalfunctionMay 3, 2016Material Fragmentation; Material Fragmentation

  LAP APPENDIX - "A PART OF THE VALVE FELL OFF INTO THE PATIENT DURING THE OPERATION. THEY COULD RETRIEVE THE LOOSE PART AND GO ON WITH THE OPERATION. MORE INFO WILL FOLLOW NEXT WEEK. TODAY I GOT THE CHANCE TO TALK TO THE CUSTOMER. SHE COULDN'T TELL ME THE LOT, BUT THE PACKAGE WILL BE SEND WITH THE PRODUCT. SO YOU WILL SEE THE LOT. THE CASE WAS A LAP APPENDIX AND THE ONLY INSTRUMENT INTRODUCED TILL THE TIME OF EVENT WAS AN ATRAUMATIC STORZ GRASPER. A PART OF THE VALVE FELL INTO THE PATIENT. THEY COULD FULLY RETRIEVE IT AND NO INJURY OCCURRED." PATIENT STATUS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5626512 ↗