Kii Optical Access SystemRecalls & reported problems across all models

We found 18 models of Kii Optical Access System by Applied Medical Resources Corporation in the FDA's device registry (GUDID). Together they are named in 309 adverse event reports in the FDA's MAUDE database, received between Feb 3, 2016 and Sep 10, 2026 — classified as 1 injury, 308 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (151 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Kii Optical Access System problems

Kii Optical Access System models

18 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Kii® OPTICAL ACCESS SYSTEM CTR73

  Laparoscope, General & Plastic Surgery
  87 reports
• Kii Optical Access System CFR73

  Laparoscope, General & Plastic Surgery
  47 reports
• Kii® Optical Access System C0R37

  Laparoscope, General & Plastic Surgery
  30 reports
• Kii Optical Access System CFR03

  Laparoscope, General & Plastic Surgery
  20 reports
• Kii® Optical Access System CTR03

  Laparoscope, General & Plastic Surgery
  20 reports
• Kii® OPTICAL ACCESS SYSTEM CTR71

  Laparoscope, General & Plastic Surgery
  19 reports
• Kii® Optical Access System C0R83

  Laparoscope, General & Plastic Surgery
  18 reports
• Kii® Optical Access system CTR33

  Laparoscope, General & Plastic Surgery
  16 reports
• Kii® Optical Access System C0Q19

  Laparoscope, General & Plastic Surgery
  14 reports
• Kii Optical Access System CFR33

  Laparoscope, General & Plastic Surgery
  8 reports
• Kii Optical Access System CFR71

  Laparoscope, General & Plastic Surgery
  7 reports
• Kii® Optical Access System C0R39

  Laparoscope, General & Plastic Surgery
  5 reports
• Kii® Optical Access System CTR01

  Laparoscope, General & Plastic Surgery
  5 reports
• Kii® OPTICAL ACCESS SYSTEM CTR34

  Laparoscope, General & Plastic Surgery
  5 reports
• Kii Optical Access System CFR01

  Laparoscope, General & Plastic Surgery
  3 reports
• Kii® OPTICAL ACCESS SYSTEM CTR72

  Laparoscope, General & Plastic Surgery
  3 reports
• Kii® OPTICAL ACCESS SYSTEM CTR74

  Laparoscope, General & Plastic Surgery
  1 report
• Kii Optical Access System CFR74

  Laparoscope, General & Plastic Surgery
  1 report

Recent Kii Optical Access System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50725089 ↗
• MalfunctionAug 31, 2026Detachment of Device or Device Component

  Procedure Performed:VATS Lobectomie.Event Description:PCF was received with few information: How the device was being used is unknown. The description of the event is unknown. There is no clinical impact to the patient. Additional information received by an Applied Medical representative via email on 20Aug26:The product was used in the same way I observed before. They use rolled-up gauze during the procedure it insert and remove it through the trocar. I did not receive a photo of the product.It was ordered via Hospital Logistics, account ID (b)(4) - Lot confirmation was performed with this account.Additional information by an Applied Medical representative, via email on 21Aug26:The duck was in total released from the trocar.Closing letter requested.Intervention:Removing the double duck bill out of the patient.Patient Status:Ok.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525350 ↗
• MalfunctionAug 31, 2026Detachment of Device or Device Component

  Procedure Performed: Laparoscopic Appendectomy. Event Description: (b)(4) Operating room submitting a product problem log. On (b)(6), during a laparoscopic case, Access system Ref#(b)(4) trocar came apart during use. The clear circular piece was retrieved without incident. Picture attached and product saved. Surgeon, Dr. "[Name]", would like to be contacted by rep. Risk management would also like a follow up. Additional information provided by Applied Medical representative via email on 13AUG2026: Thank you very much for letting me know. I was actually on site yesterday speaking with Dr. "[Name]", however I was unaware that Dr. "[Name]" experienced an issue. I am glad to hear that the patient is doing well. I will find out when he is on the schedule next and make sure to come in and speak with him. Thank you for making me aware. If you could, please put me in touch with the risk management team, I will absolutely reach out to them as well. Thank you for your time. Additional information provided by Nurse from the facility via email on 17AUG2026: The piece fell into the abdomen and was successfully retrieved from the patient. No instrumentation passed through the event unit during t

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50524769 ↗
• MalfunctionJul 27, 2026Fracture

  Procedure Performed: Robotic-assisted Esophagectomy. Event Description: During the surgery, the Trocar 12mm port broke into right pleural cavity into what the team felt was 4 pieces/shards. 3 pieces/shards were located with 1 potential shard left in the patient likely causing no harm. Imaging completed with no location of a remaining shard. Device failed (e.g. broke, couldn't get it to work or stopped working). Patient Status: No patient injury indicated. The date of the event is unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50009485 ↗
• MalfunctionMay 18, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC PROSTATECTOMY. EVENT DESCRIPTION: THE RING IN THE MIDDLE CAME OUT OF THE TROCAR. THEY HAD TO RETRIEVE IT OUT OF THE PATIENT. ALL PIECES WERE RETRIEVED. INTERVENTION: REMOVED THE RING OUT OF THE PATIENT, DISPOSED OF THE TROCAR AND USED A NEW ONE. PATIENT STATUS: NO PATIENT INJURY INDICATED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210563 ↗
• MalfunctionMay 6, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC HYSTERECTOMY. EVENT DESCRIPTION: DURING THE PROCEDURE, THE APPLIED TROCAR EXPERIENCED DEVICE FAILURE WHEN A CLEAR SEAL COMPONENT BECAME DISLODGED FROM THE TROCAR HOUSING AND FELL INTO THE PATIENT'S ABDOMINAL CAVITY. THE FOREIGN OBJECT WAS IDENTIFIED AND RETRIEVED. INTERVENTION: THE FOREIGN OBJECT WAS IDENTIFIED AND RETRIEVED. PATIENT STATUS: NO CLINICAL IMPACT. THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107023 ↗
• MalfunctionApr 24, 2026Fracture

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: WE USE YOUR LAPAROSCOPIC TROCARS. A CTR03 WAS BEING USED ON AN CASE AND THE SLEEVE BENT/TROCAR SNAPPED IN HALF. LOT: 1573129 EXP:2028-12-16. ALL PIECES RETRIEVED. NO HARM TO PATIENT. I HAVE THE FAULTY TROCAR. I LOOK FORWARD TO HEARING FROM YOU. ADDITIONAL INFORMATION PROVIDED BY [USER FACILITY REPRESENTATIVE] ON 14APR2026: I HAVE THE TROCAR AND ORIGINAL PACKAGE FOR RETURN. BEND/BREAK OCCURRED AT SHAFT. THE BEND/BREAK WAS IDENTIFIED DURING INSERTION. THE TROCAR WAS NOT USED WITH A ROBOT. YES, THE OBTURATOR WAS INSERTED IN THE CANNULA AT THE TIME OF THE INCIDENT PICTURE PROVIDED. ADDITIONAL INFORMATION PROVIDED BY [USER FACILITY REPRESENTATIVE] ON 16APR2026: THE TROCAR WAS THE 3RD TROCAR OF THE CASE. THE 1ST 2 WENT IN WITHOUT ISSUES. THE SCRUB DID NOT NOTICE ANY UNUSUAL BEHAVIOR PRIOR TO THE TROCAR JUST SNAPPING. INTERVENTION: THEY REMOVED THE BROKEN PART AND USED A DIFFERENT TROCAR AND SLEEVE. PATIENT STATUS: STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24990233 ↗
• MalfunctionMar 5, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC LIVER RESECTION. EVENT DESCRIPTION: THE ENTIRE OF DUCKBILL FELL INTO THE ABDOMINAL CAVITY. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED WITH A HOSPITAL INVENTORY, AND THE PROCEDURE WAS COMPLETED. THIS EVENT UNIT WILL BE RETURNED. INTERVENTION: REPLACED WITH A HOSPITAL INVENTORY AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524822 ↗
• MalfunctionJan 14, 2026Fracture

  PROCEDURE PERFORMED: GASTRECTOMY. EVENT DESCRIPTION: "THE OPTURATOR WAS BROKEN." PRODUCT IS AVAILABLE FOR RETURN. PATIENT STATUS: NO PATIENT STATUS PROVIDED, EVENT OCCURRED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068193 ↗
• MalfunctionDec 19, 2025Fracture; Fracture

  PROCEDURE PERFORMED: LAPAROSCOPIC HERNIORRHAPHY. EVENT DESCRIPTION: THIS MORNING WE HAVE HAD ANOTHER 12MM TROCAR ISSUE WITH THE TAB ON THE SIDE BREAKING OFF WHEN [SURGEON] WAS ATTEMPTING TO REMOVE THE WHITE CAP. NO HARM OCCURRED TO THE PATIENT AND THE BROKEN PIECE WAS RETRIEVED. I HAVE THE TROCAR AND THE PACKAGING AND I ASSUME WHEN [HEALTHCARE WORKER] GETS BACK NEXT WEEK SHE WILL TAKE A LOOK AND THEN LET YOU HAVE IT, [APPLIED REPRESENTATIVE], BUT NOT MY DECISION TO MAKE OF COURSE. I RECEIVED THIS EMAIL THIS MORNING THAT SAID A GENERAL SURGEON DR. [NAME] AT [HOSPITAL] HAD AN ISSUE WITH A 12MM APPLIED MEDICAL TROCAR. ONE OF THE TABS BROKE OFF WHEN THE SURGEON TRIED REMOVING THE SEAL CAP FROM THE TROCAR. THE INSTRUMENT WAS SAVED, AND THEY WILL NEED TO DO THEIR OWN INVESTIGATION BEFORE ALLOWING THE TROCAR TO BE RELEASED TO APPLIED MEDICAL. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 05DEC2025: I WAS NOT ABLE TO SPEAK WITH THE SURGEON BUT WAS TOLD HE SAID HE PINCHED THE TABS TO REMOVE THE SEALING HOUSE, AND THE ONE SIDE BROKE. THE TAB DID NOT FALL INTO THE TROCAR. THE SURGEON DID NOT HAVE PINCH ANY HARDER THAN HE NORMALLY WOULD. EVENT HAPPENED AT THE END OF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850687 ↗
• MalfunctionNov 13, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPROSCOPIC SUTURE GASTRORRHAPHY WITH OMENTUM PATCH. EVENT DESCRIPTION: YES, DR. [NAME] DID HAVE AN ISSUE WITH A TROCAR. ON SATURDAY, (B)(6) DR. [NAME] WAS FINISHING UP A LAPROSCOPIC SUTURE GASTRORRHAPHY WITH OMENTUM PATCH, AND WHEN HE DEPRESSED THE CLEAR TABS ON EACH SIDE OF THE 12MM CTR73 TROCAR TO DE-INSUFFLATE THE ABDOMEN, ONE OF THE TWO CLEAR TABS ON THE SIDE OF THE TROCAR BROKE OFF AT THE POINT AFTER THE REINFORCEMENT ATTACHES (AT THE CURVE WHERE THE TAB GOES PARALLEL TO THE TROCAR) AND THE BROKEN PIECE WENT INTO THE OPENING OF THE TROCAR AND INTO THE PATIENT. HE FOUND THE BROKEN-OFF PIECE IN THE ABDOMEN WITHOUT DIFFICULTY AND REMOVED IT. THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT THAT WE KNOW OF THEN OR THUS FAR. WE HAVE THE TROCAR AND I BELIEVE WE ALSO HAVE THE BROKEN-OFF PIECE, AND YOU TENTATIVELY CAN PICK IT UP WEDNESDAY. NO OTHER TROCAR WAS SUBSTITUTED OR USED SINCE THE PROCEDURE WAS BASICALLY FINISHED. ADDITIONAL INFORMATION PROVIDED BY USER FACILITY ON 04NOV2025: THE BEND/BREAK OCCURRED AT THE TAB. THE BEND/BREAK WAS IDENTIFIED DURING USE. THE TROCAR WAS INSERTED WITH ROTATION. THERE WAS NO DIFFICULTY DURING INSERTION. THIS TROCAR WAS NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547067 ↗
• MalfunctionNov 4, 2025Fracture; Fracture

  PROCEDURE PERFORMED: HEPATECTOMY. EVENT DESCRIPTION: THE OBTURATOR WAS ALREADY BROKEN, SO THEY COULDN'T USE IT. PRODUCT IS AVAILABLE FOR RETURN. INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW DEVICE. PATIENT STATUS: NO PATIENT STATUS PROVIDED, EVENT OCCURRED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23469201 ↗
• MalfunctionNov 3, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC SLEEVE GASTRECTOMY. EVENT DESCRIPTION: WHILE CLOSING WHILE PULLING TROCARS OUT THE TAB CONNECTED TO SEAL HOUSING BROKE OFF AND INTO THE PATIENT. PIECE WAS REMOVED FROM PATIENT. ANOTHER PRODUCT NOT DEEMED NECESSARY. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 28OCT2025: NO LOT NUMBER WAS PROVIDED THE LATCH TAB ON THE CANNULA BROKE OFF AND FELL INTO THE PATIENT. THEY WERE ABLE TO RETRIEVE IT FROM THE PATIENT. I WAS NOT ABLE TO GET A CLEAR ANSWER ON WHETHER THE TAB WAS BEING PINCHED AT THE TIME OF BREAKAGE. INTERVENTION: PIECE WAS REMOVED FROM PATIENT. ANOTHER PRODUCT NOT DEEMED NECESSARY. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23458967 ↗
• MalfunctionOct 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: HIATAL HERNIA PROCEDURE. EVENT DESCRIPTION: TROCAR CAME APART. BLACK RUBBER SEAL CAME OUT OF TROCAR. ALL PIECES AND PACKAGING WERE SAVED AND ARE BEING RETURNED. NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 08OCT2025 VIA EMAIL: REF: C0Q19. LOT: 1558047. DURING DR. [NAME]S SECOND XI HIATAL HERNIA YESTERDAY AFTERNOON, THE 8X100MM TROCAR CAME APART. THE BLACK RUBBER SEAL/LINER PULLED OUT OF THE TROCAR. I HAVE SAVED THE TROCAR AND PACKAGING. NO PIECES FELL INTO THE PATIENT. YES, THE ENTIRE SEAL COMPONENT FELL OUT. NO INTERNAL SEAL COMPONENTS WERE REMOVED OR CUT TO INSPECT THE DAMAGED COMPONENT. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23362585 ↗
• MalfunctionSep 19, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: GB. EVENT DESCRIPTION: THE PLASTIC PART (CANNULA WING TAB) WAS BROKEN DURING THE USE OF THE TROCAR." PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 17SEP2025 FROM AMK REGIONAL SALES MANAGER: "THE BEND/BREAK WAS IDENTIFIED AT DURING INSERTION. THE TROCAR WAS INSERTED LIKE ROTATED IN ALTERNATING CLOCKWISE. THERE WAS NO DIFFICULTY DURING INSERTION. THE BREAK WAS CONSIDERED TO BE A CLEAN BREAK. THE BREAK DID NOT CAUSE PARTICULATION. THIS TROCAR WAS NOT USED WITH A ROBOT. AT THE TIME OF THE INCIDENT, THERE WAS A HAND ON THE CANNULA." INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW DEVICE. PATIENT STATUS: THERE WAS NO PROBLEM WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098733 ↗

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