Kii Shielded Bladed Access System CFB73Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00607915117634), received between Oct 8, 2015 and Sep 16, 2026 — classified as 1 death, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792815 ↗
• MalfunctionMar 11, 2026Material Fragmentation

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: PIECE OF TROCAR BROKE (AT THE TIP). PATIENT STATUS: NO PATIENT INJURY OR ILLNESS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569970 ↗
• MalfunctionJul 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPY. EVENT DESCRIPTION: INFORMATION PROVIDED BY THE FACILITY ON 17JUL2025: PART OF THIS TROCAR FELL IN THE ABDOMINAL CAVITY WHILE PERFORMING GYNECOLOGY LAPAROSCOPIC CASE (CLEAR PLASTIC PIECE). IT WAS JUST INCIDENTAL THAT WE NOTICED DURING THE SURGERY THAT THE PLASTIC PIECE FLOATING IN THE ABDOMINAL CAVITY. WE HAVE TO OPEN SECOND TROCAR TO CONFIRM THAT IT CAME FROM THE KII 10MM TROCAR THAT IS IN THE PATIENT. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY ON 22JUL2025: LAPAROSCOPIC PORT. OBSERVED PLASTIC RING IN THE ABDOMEN FROM THE PORT INSIDE THE ABDOMEN. PLACED SPONGE DOWN THE TROCAR TO CLEAN OUT THE PORT AND MUST HAVE DISLODGED AT THAT TIME AND BEEN PUSHED INTO THE ABDOMEN. THERE WAS NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. REMOVED PLASTIC RING FROM THE ABDOMEN. CURVED KELLY USED TO GRASP SPONGE AND PUT IT DOWN TROCAR TO CLEAN OUT THE PLASTIC INTERNAL RING. ADDITIONAL INFORMATION PROVIDED BY FACILITY ON 05AUG2025: YES PIECES FELL INTO THE PATIENT. IT WAS DISASSEMBLED TO MATCH UP WITH A SECOND ONE THAT WAS USED AS A REFERENCE, MAKING SURE THAT ALL THE PIECES WAS RETRIEVED FROM THE AT THAT TIME. YES INSTRUMENTATION PASSED THROUGH THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22681776 ↗
• MalfunctionDec 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC ANTERIOR RESECTION. EVENT DESCRIPTION: HOW WAS THE DEVICE BEING USED/WHAT ACTION WAS BEING PERFORMED WHEN THE EVENT OCCURRED? INSERTING/REMOVING LAPAROSCOPIC INSTRUMENTS THROUGH PORT. FOREIGN BODY IDENTIFIED AND REMOVED UNDER VISION. NO REPLACEMENT REQUIRED AS PROCEDURE WAS FINISHING. NO OTHER PRODUCTS REQUIRED. NO PROBLEMS IDENTIFIED AT BEGINNING OF CASE - NO GAS LEAKING UNTIL THE END OF THE CASE, WHEN IT WAS DISCOVERED THAT THE SEAL WAS INSIDE THE PATIENT. THE SEAL WAS ABLE TO BE RETRIEVED FROM THE PATIENT. THE PORT DID NOT NEED TO BE REPLACED AS IT WAS THE END OF THE CASE. TYPE OF INTERVENTION: NO REQUIREMENT FOR REPLACEMENT AS PROCEDURE WAS FINISHED. PATIENT STATUS: NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15999823 ↗
• MalfunctionJan 17, 2022Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC APPENDECTOMY. EVENT DESCRIPTION: TRANSLATION FROM COMPLAINT FORM: DURING THE SURGERY THE DOCTORS REALISED PLASTIC PARTICLES OF THE TROCAR IN THE ABDOMEN OF THE PATIENT. THE PARTICLES HAVE BEEN COLLECTED AND SAVED IN A SMALL PREPARATION CONTAINER. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 10-JAN-2022: THE TROCAR WAS INSERTED WITH THE DIRECT INSERTION TECHNIQUE. WHEN THE SCOPE WAS INSERTED, AFTER THE BALLOON WAS INFLATED AND UPON CHECKING THE OTHER TROCAR PLACEMENTS, THE OR STAFF DISCOVERED THAT THE REFLECTING PARTICLES FROM BESIDE THE TROCAR BALLOON WERE STUCK ON THE ABDOMINAL WALL OF THE PATIENT. AFTER FURTHER CHECKING FOR OTHER PARTICLES IN THE ABDOMEN AND FINDING SOME, OTHER TROCARS HAVE BEEN PLACED TO COLLECT THE PLASTIC PARTICLES. THEY WERE COLLECTED USING A GRASPING FORCEPS. THE TROCAR HAS BEEN REMOVED AND REPLACED WITH ANOTHER ONE AFTER CHECKING FOR PLASTIC RESIDUES. THE OR STAFF HAS EXAMINED THE TROCAR OBTURATOR AND CANNULA. THE PLASTIC PIECES WERE FOUND TO HAVE CHIPPED OFF OF THE CANNULA BETWEEN THE CANNULA TIP AND THE BALLOON. TYPE OF INTERVENTION: RETRIEVAL OF SEPARATED PARTS. PATIENT STATUS: HEALTHY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266806 ↗
• MalfunctionDec 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: INTESTINAL (TRANSVERSUM) RESECTION. EVENT DESCRIPTION: INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2021 FROM APPLIED MEDICAL REPRESENTATIVE: JUST RECEIVED A CALL FROM CUSTOMER REPORTING A CFB73 THAT "LOST" THE TRANSPARENT MEMBRANE DURING SURGERY. THE MEMBRANE WAS DETECTED IN THE ABDOMEN BY ACCIDENT, CUSTOMER ASSUMES IT REMAINED IN THE ABDOMEN WHEN REMOVING THE TROCAR. INFORMATION RECEIVED FROM COMPLAINT FORM VIA EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2021: THE TROCAR WAS USED FOR LAPAROSCOPIC ACCESS DURING A TRANSVERSUM RESECTION. THE INCIDENT OCCURRED DURING INSERTION OF A 10MM RETRIEVAL BAG THROUGH THE TROCAR. AFTER INSERTING THE 10 MM RETRIEVAL BAG THROUGH THE TROCAR, IT WAS NOTICED THAT THE STICK OF THE RETRIEVAL BAG WAS HARDER TO REMOVE THROUGH THE TROCAR AND STUCK TO THE SEAL. A CLEAR PLASTIC PART OF THE SEAL WAS THEN FOUND IN THE ABDOMEN, WHICH HAD COME LOOSE. TO RETRIEVE THE PART, IT WAS CUT IN HALF. IT WAS THEN FOUND THAT THIS PART WAS MISSING FROM THE TROCAR. ACCORDING TO THE OR-STAFF, ALL TOOLS WERE USED ACCORDING TO THE RULES AND NO PRESSURE WAS EXERTED ON THE TROCAR. THERE WERE NO CHANGES IN HEALTH. BECAUSE IT HAPPENED NEARLY AT THE END O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12962834 ↗
• MalfunctionOct 21, 2021Material Fragmentation; Gas/Air Leak; Material Fragmentation; Gas/Air Leak

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: [TRANSLATION] I WOULD LIKE TO POINT OUT TO YOU A PROBLEM OF MATERIOVIGILANCE OBSERVED ON A TROCARD SLEEVE (REF CFB73 LOT 1424774). THE SLEEVE WAS DEFECTIVE, THE BALLOON WAS PUNCTURED, WE KEPT THE PRODUCT (IT WAS IN CONTACT WITH THE PATIENT BUT WAS DECONTAMINATED). FROM THE FORM: THE BALLOON WAS PIERCED AND THE SURGEON WAS NOT ABLE TO INFLATE IT. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 25OCT21: THERE WAS VISIBLE DAMAGE TO THE BALLOON. THERE WAS SCRATCHES ON THE SHAFT OF THE TROCAR. METAL RETRACTORS WERE USED. FARABEUF RETRACTOR (FOR THE OPEN COELIOCHIRUGIE TECHNIQUE). NO SHARP INSTRUMENTATION COME IN CONTACT WITH THE BALLOON. THE TEAMS USED A CFB73 TROCAR TO PERFORM OPEN LAPAROSCOPIC SURGERY. THE SURGEON PLACED THE TROCAR. THEY INFLATED THE FIXATION BALLOON AND THEN PULLED THE TROCAR UP. THE TROCAR CAME STRAIGHT OUT OF THE BODY: AT THIS MOMENT, THEY NOTICED THAT THE FIXATION BALLOON WAS PIERCED (AND NOT INFLATED CORRECTLY) AND THE DISTAL PART OF THE TROCAR WAS DAMAGED. THE NURSE CHECKED IN THE PRIMARY PACKAGING OF THE TROCAR: NO DEBRIS PRESENT. NO PATIENT INJURY: THE SURGEON ALSO CHECKED THAT NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674076 ↗
• MalfunctionOct 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: HEPATECTOMY. EVENT DESCRIPTION: WHEN GRASPER INSERT THIS DEVICE THROUGH THE SEPTUM IS NOT SMOOTHLY. SURGEON OPEN THE SEAL HOUSE AND CHECK, THEN THEY FIND THE VALVE WAS COMING OFF. THEY REPLACED WITH A NEW ONE TO COMPLETED THIS SURGERY. PRODUCT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 07OCT2021 FROM THE DISTRIBUTOR: A 5MM GRASPER WAS USED WITH THE TROCAR. NO OTHER INSTRUMENTATION WAS USED PRIOR TO THE INCIDENT. NO INTERNAL SEAL COMPONENTS WERE REMOVED OR CUT IN ORDER TO INSPECT THE DAMAGED COMPONENT. THE VALVE DID DETACH. TYPE OF INTERVENTION: THE CASE WAS COMPLETED WITH A NEW ONE. PATIENT STATUS: FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12632417 ↗
• MalfunctionSep 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE PERFORMED: LAPAROSCOPIC APPENDECTOMY. EVENT DESCRIPTION: TRANSLATION: "ON FRIDAY, (B)(6), A (B)(6) YEARS OLD PATIENT WAS ADMITTED FOR A LAPAROSCOPIC APPENDECTOMY PROCEDURE. IT WAS SUPPLIED A KIT OF TROCAR COMPOSED BY 1 TROCAR OF 12MM AND 2 TROCARS OF 5MM. ON THE FIRST PORT, THE PHYSICIAN PROCEEDS TO INSERT THE 12MM TROCAR USING A HASSON TECHNIQUE, WITHOUT THE PERITONEUM, AT THE MOMENT WHEN THE OBTURATOR WAS REMOVED THE SLEEVE STARTED TO FILLED WITH BLOOD, AFTER THAT, THEY INSUFFLATE AND PUT THE 5MM TROCARS ON 2 PORTS. THEY NOTICED A MASSIVE BLEEDING, ASPIRATE THE BLOOD WITHOUT DECREASING VOLUME; THEREFORE, THEY DECIDED TO PROCEED TURNING INTO AN OPEN SURGERY. INJURIES PROVOKED WERE DAMAGE ON CAVA AND MESENTERY." TYPE OF INTERVENTION: UNK. PATIENT STATUS: TRANSLATION: "STABLE, INTERMEDIATE THERAPY".

  Patient problems: Blood Loss

  MAUDE report 6845652 ↗
• MalfunctionDec 29, 2016Gas/Air Leak; Gas/Air Leak

  LAPAROSCOPIC APPENDECTOMY - "THIS EVENT DID NOT CAUSE PATIENT HARM. THE PATIENT WAS UNDERGOING A LAPAROSCOPIC APPENDECTOMY. DURING THE PROCEDURE A BLUNT TIPPED TROCAR WAS PLACED THROUGH THE PATIENT'S FASCIA AND PERITONEUM UNDER DIRECT VISION AND SUTURED INTO PLACE. THE ABDOMEN WAS INSUFFLATED WITH CO2 BUT THE TROCAR WAS LEAKING WHICH RESULTED IN LESS CO2 BEING PLACED IN THE ABDOMEN AS IS USUAL." TYPE OF INTERVENTION: UNK. PATIENT STATUS: "THIS EVENT DID NOT CAUSE PATIENT HARM."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6213529 ↗
• DeathOct 8, 2015Device Operates Differently Than Expected

  LAPAROSCOPIC OVARIAN CYSTECTOMY PROCEDURE, ROBOTIC ASSISTED. A 12 MM TROCAR SLEEVE ADVANCED INTO ABDOMEN THROUGH A 12 MM INCISION. AFTER ENTRY INTO ABDOMINAL CAVITY, LARGE AMOUNT OF BLOOD ACCUMULATION NOTED. A SECOND INCISION WAS MADE AND 5 MM TROCAR SLEEVE ADVANCED TO ALLOW IRRIGATOR AND EVACUATION OF BLOOD. AN EMERGENT EXPLORATORY LAPAROTOMY OCCURRED REVEALING LARGE AMOUNT OF BLOOD IN ABDOMEN. VASCULAR SURGERY WAS CALLED AND IMMEDIATELY AVAILABLE. ATTEMPTED REPAIR AND RESUSCITATION WERE UNSUCCESSFUL. POSTMORTEM EXAM REVEALED PUNCTURE WOUND THROUGH RIGHT COMMON ILIAC ARTERY AND PORTION OF LARGE INTESTINE. COMMON DEVICE NAME.: SHIELDED BLADED OBTURATOR W/ADVANCED FIXATION SLEEVE 12/100 MM. APPROXIMATE AGE OF DEVICE.: DEVICE NEW, STERILE, ONE-TIME USAGE. EXPIRATION 08/03/2015.

  Patient problems: Exsanguination; Laceration(s)

  MAUDE report 5152210 ↗