Kii Optical Access System CFR33Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00607915123222), received between Sep 16, 2016 and Jan 7, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC THORACOSCOPY. EVENT DESCRIPTION: PARTS OF THE CANNULA BROKE OFF INSIDE OF THE PATIENT. ALL PARTS OF THE BROKEN PIECES WERE RETRIEVED. PATIENT IS FINE, NO INJURY. THE PROCEDURE WAS FINISHED BY USING ANOTHER TROCAR. INTERVENTION: USED ANOTHER TROCAR. PATIENT STATUS: PATIENT IS FINE, NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21092716 ↗
• MalfunctionMay 6, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: ADRENALECTOMY. EVENT DESCRIPTION: PRODUCT: CFR33. "WHEN THE OPERATION WAS ABOUT TO BE COMPLETED AND THE BLEEDING SITUATION WAS CHECKED, A GREEN FRAGMENT WAS DISCOVERED IN THE ABDOMEN, IDENTIFIED UPON RETRIEVAL AS A FRAGMENT OF A TROCAR. AN EXTENSIVE SEARCH WAS MADE FOR ANOTHER FRAGMENT, BUT IT WAS NOT FOUND. THE PATIENT'S CONDITION IS CURRENTLY STABLE; HOWEVER, THE DOCTOR WILL CONTINUE TO MONITOR IT CLOSELY." ADDITIONAL INFORMATION HAS BEEN RECEIVED ON 03MAY2024 VIA EMAIL FROM DISTRIBUTOR: "THE PATIENT STAYED STABLE DURING THEIR HOSPITAL STAY, AND THERE WAS NO NEED TO EXTEND IT BECAUSE OF THIS INCIDENT. THE PATIENT RETURNED FOR A CHECK-UP ON (B)(6) 2024, AND EVERYTHING WAS NORMAL. HERE IS WHAT HAPPENED DURING THE PROCEDURE: AS THE SURGERY NEARED COMPLETION, DURING THE SURGEON'S FINAL CHECK FOR ANY BLEEDING, FRAGMENTS WERE DISCOVERED INSIDE THE ABDOMINAL CAVITY. THE CAUSE OF THE CFR33 RUPTURE IS UNKNOWN. THE TIP WAS WHERE THE FRACTURE OCCURRED. NO ROBOT WAS INVOLVED IN THE SURGERY, AND C6001 WAS INSIDE THE CANNULA AT THE TIME OF THE INCIDENT." INTERVENTION: IT WAS FINISHED WITH THE SAME INSTRUMENT. PATIENT STATUS: THE PATIENT STAYED STABLE DURING THEIR HOSPITAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19255426 ↗
• MalfunctionNov 19, 2021Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: "A FREE FLOATING PIECE WAS NOTED IN THE ABDOMEN IT WAS SECURED ON THE STERILE FIELD WHEN TROCAR WAS REMOVED FROM PATIENT A SEARCH WAS DONE FOR ADDITIONAL PIECES . 2 TOTAL PIECES WERE TAKEN FROM PATIENT." PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL (B)(6) 2021 FROM USER FACILITY: IT IS UNKNOWN WHEN THE INCIDENT OCCURRED. THE PROCEDURE PERFORMED WAS LAPAROSCOPIC CHOLECYSTECTOMY. THERE ARE NO PICTURES AVAILABLE FOR THE DEVICE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL (B)(6) 2021 FROM USER FACILITY: IT IS UNSURE IF DIRECT PRESSURE OR ROTATION WAS USED DURING INSERTION. NO DIFFICULTY WAS REPORTED WITH INSERTION. CUSTOMER STATES THAT ONLY A SMALL SECTION BROKE ON THE END OF THE TROCAR. THE TWO PIECES THAT WERE RECOVERED SEEMED TO BE ALL THAT BROKE OFF THE TROCAR. THE PATIENT'S ABDOMINAL CAVITY WAS EXAMINED FOR ANY OTHER PIECES. THE TROCAR WAS NOT USED WITH A ROBOT. AN ATRAUMATIC BOWEL GRASPER WAS USED WITH THIS TROCAR. MARYLAND DISSECTOR, SCISSORS, AND CLIP APPLIER WAS ALSO USED IN THE CASE. "CASE WAS COMPLETED LAPAROSCOPICALLY, PATIENT CONDITION WAS STABLE WHEN THEY LEFT OR. SO FAR NO R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12846321 ↗
• MalfunctionApr 10, 2019Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: TYMECTOMY. EVENT DESCRIPTION: I SELF AND [] WAS PRESENT DURING THE OR, AND ALL OF A SUTTON THEY COULD SEE A LOTTEL PIECE OF PLASTIC, IN THE THORAGIC CAVETY. AFER THIS ALLE TROCARS WHERE TAKEN OUT OF THE PATIENT AND INSPECTED TO FIND THE PLACE WHERE THE PIECE WAS MISSING. NEITHER THEY OR WE COULD FIND A PLACE IN THE TROCARS, WHERE A PIECE WAS MISSING. EVERYTHING WAS GATHERED AND IS READY TO BE SENT BACK FROM []. DURING THE OR THE RETENTIONDISK WAS TAKEN OFF THE TROCARS. ALL THE INSTRUMENTS OS AT [] DEPARTMENT, []. THEY ARE READY TO BE SENT BACK. ADDITIONAL INFORMATION RECEIVED BY PHONE FROM THE SALES REP ON 22MAR19: 1 DEVICE INCIDENT, 1 PIECE OF PLASTIC GREEN COLOR WAS RETRIEVED FROM THE PATIENT. AS THEY DO NOT KNOW FROM WHICH DEVICE IT BELONGS, ALL 5 DEVICES ARE RETURNING. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM THE SALES REP ON 26MAR19: I CANNOT DESCRIBE HOW THE FRACTURE OCCURRED. THE FRACTURE DID NOT CAUSE PARTICULATION. THERE WAS ONLY ONE PIECE OF TROCAR BROKEN AND IT WAS FOUND AND TAKEN OUT OF THE PATIENT. THIS PORT WAS NOT USED WITH A ROBOT. THE PORTS WERE INTRODUCED WITH A ROTATING INSERTION METHOD. 5 DEVICES RETURNING ARE: CTR03 LOT 1319242, CTS02

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8501946 ↗
• MalfunctionApr 7, 2017Material Fragmentation; Material Fragmentation

  THORACOSCOPY - "SLEEVE FROM CFR33 GOT PRESSED AGAINST RIBS OF PATIENT AND PIECES GOT INTO THE CAVITY." ADDITIONAL INFORMATION RECEIVED FROM SALES REP ON 24 MARCH 2017: THE MODEL OF THE PRODUCT IS CFR33 WITH LOT # 1282053. THE PROCEDURE WAS THORACOSCOPY USING 1 TROCAR AND ONLY THE SLEEVE. SLEEVE HAD (CRACKED) BROKEN BUT NO PIECES ENDED UP IN PATIENT. PATIENT IS OK. PATIENT STATUS: "OK."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6474306 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  LAPAROSCOPIC UTERINE MYOMECTOMY - "THIS IS A COMPLAINT FROM THE MARKET. (B)(4). TWO (2) EACHES OF CFR33S WITHOUT FRAGMENTS WILL BE RETURNED TO AMR. PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION." COMPLAINT SHEET - "THE BALLOON WOULD NOT INFLATE INSIDE THE PATIENT. PROCEDURE: LAPAROSCOPIC UTERINE MYOMECTOMY. TWO (2) EA. OF CFR33 WERE RETURNED TO OLYMPUS AND VISUALLY INSPECTED: ONE OF THE UNITS SHOWED NO VISIBLE DAMAGE; THE OTHER UNIT HAD NO VISIBLE DAMAGE WITH THE BALLOON AND A MISSING PORTION OF APPROX. 2.2 MM X 2.0 MM WAS FOUND WITH THE SEPTUM. NO FRAGMENT MATCHING THE PORTION WAS RETURNED TO (B)(4). THE UNITS WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. (B)(4).' PATIENT STATUS - "NO PATIENT INJURY".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370900 ↗
• MalfunctionNov 18, 2016Inflation Problem; Inflation Problem

  MYOMECTOMY - "THIS DEVICE CANNOT INFLATE." PATIENT STATUS: "FINE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6113807 ↗
• MalfunctionSep 16, 2016Break; Break

  THORACTOSKOPIC PROCEDURE - "A PIECE OF THE CANNULA FELL OF INTO THE THORACIC CAVITY OF THE PATIENT. THE PIECE WAS FOUND AND REMOVED. " ADDITIONAL INFORMATION RECEIVED ON AUGUST 19, 2016: FRACTURE OCCURRED AT THE TIP. THE FRACTURE DID NOT CAUSE PARTICULATION. IT WAS A CLEAN BREAK. NO ROBOT WAS USED. USED NORMAL METHOD OF INSERTION PER IFU. UNKNOWN IF OTHER INSTRUMENTS WERE USED. TYPE OF INTERVENTION: THE PIECE WAS FOUND AND REMOVED. PATIENT STATUS - OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5956854 ↗