Kii® Low Profile Optical Access System CTR22Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607915126506), received between Jun 18, 2021 and Mar 10, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Fracture

  PROCEDURE PERFORMED: TRANSORAL ENDOSCOPIC RIGHT THYROID LOBECTOMY AND ISTHMUSECTOMY, VESTIBULAR APPROACH. INTRAOPERATIVE ULTRASOUND OF THE THYROID AND NECK FOR SURGICAL PLANNING. FIBEROPTIC LARYNGOSCOPY. EVENT DESCRIPTION: TWO TROCARS USED DURING CASE BOTH WITH SAME LOT NUMBER DEFECTIVE. FIRST TROCAR BROKE IN TWO PIECES WHEN BEING PLACED. BOTH PIECES RETRIEVED AND ABLE TO BE PLACED TOGETHER TO VERIFY NO MISSING PIECES. SECOND TROCAR FROM SAME LOT NUMBER ALSO DISFORMED AND CREATED A PROBLEM CAUSING DIFFICULTY ADVANCING INSTRUMENT THROUGH. BOTH TROCARS FROM LOT 1522399 REF #(B)(4). TWO ADDITIONAL TROCARS OPENED WITH DIFFERENT LOT NUMBERS THAT FUNCTIONED AS EXPECTED. ADDITIONAL INFORMATION PROVIDED BY [HOSPITAL REPRESENTATIVE] ON 23FEB2026 (ENTERED BY APPLIED MEDICAL REPRESENTATIVE): AS I WAS NOT INVOLVED IN THE CASE I HAVE VERY FEW ADDITIONAL DETAILS TO ADD. EVENT DATE-1/2/2026 THERE WAS NO PATIENT INJURY. THERE WERE TWO DEVICE W/ ISSUES #1 BROKE INTO TWO PIECES AND WAS RETRIEVED #2 -SAME LOT # -DEFORMED AND DIFFICULT TO ADVANCE. DEVICE WAS CHANGED OUT FOR A DIFFERENT LOT # AND FUNCTIONED AS EXPECTED. ADDITIONAL INFORMATION PROVIDED BY [HOSPITAL REPRESENTATIVE] ON 04MAR2026 (ENTERED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24565216 ↗
• MalfunctionFeb 20, 2026

  TWO TROCARS USED DURING CASE BOTH WITH SAME LOT NUMBER DEFECTIVE. FIRST TROCAR BROKE IN TWO PIECES WHEN BEING PLACED. BOTH PIECES RETRIEVED AND ABLE TO BE PLACED TOGETHER TO VERIFY NO MISSING PIECES. SECOND TROCAR FROM SAME LOT NUMBER ALSO DISFORMED AND CREATED A PROBLEM CAUSING DIFFICULTY ADVANCING INSTRUMENT THROUGH. BOTH TROCARS FROM LOT 1522399 REF #CTR22. TWO ADDITIONAL TROCARS OPENED WITH DIFFERENT LOT NUMBERS THAT FUNCTIONED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399961 ↗
• MalfunctionNov 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC NISSEN FUNDOPLICATION EVENT DESCRIPTION: A TRANSPARENT PART OF THE TROCAR REDUCER HAS BECOME DETACHED FROM THE TROCAR HEAD. CHANGED TROCAR. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 28OCT25: THE COMPONENT DETACHED AS A PIECE. IT WAS A TRANSPARENT PART OF THE DOUBLE DUCKBILL. IT FELL INTO THE PATIENT AND RETRIEVED. THE COLOR WAS CLEAR TRANSPARENT. NO INFORMATION REGARDING INSTRUMENTATION PASSED THROUGH THE EVENT UNIT(S) DURING THE PROCEDURE. NO INFORMATION IF ANY INTERNAL SEAL COMPONENTS REMOVED OR CUT TO INSPECT THE DAMAGED COMPONENT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 31OCT25: A SINGLE USE KII TROCAR SEAL, WHICH IS ALSO CALLED REDUCER AS FAR AS I KNOW. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 05NOV25: PROCEDURE: LAPAROSCOPIC NISSEN FUNDOPLICATION. CONCOMITANT DEVICE: [COMPETITOR BRAND] 5MM GRASPER, [COMPETITOR BRAND] EXCEL REF X32047. TRANSPARENT PART OF THE KII TROCAR SEAL DETACHED. NO PIECES FELL INTO THE PATIENT, IT STAYED INSIDE THE TROCAR SLEEVE. THE COLOR WAS CLEAR(TRANSPARENT). [COMPETITOR BRAND] EXCEL REF X32047 INST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23518482 ↗
• MalfunctionJun 9, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: INCOMING INSPECTION. DETAILED DESCRIPTION OF EVENT: DISTRIBUTOR: INCOMING INSPECTION PO# (B)(4). THIS IS A COMPLAINT FROM DISTRIBUTOR EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: APRIL 15, 2022. WE FOUND DEFECTS AS THE RESULT OF INCOMING INSPECTION OF THE PRODUCTS. PLEASE REFER TO THE ATTACHMENT MATERIAL FOR THE QUANTITY WHICH RETURNS THE PRODUCTS. WE FOUND THE DEFECTS THAT ALREADY INFORMED APPLIED MEDICAL BY CER. WE JUST INFORM YOU THE DEFECT AND RETURN THE PRODUCTS FOR FOLLOWING DEFECTS. YOU DO NOT NEED INVESTIGATION. HAIRLIKE OBJECT IN POUCH - CTR22 LOT #1441067 (1 EA.) PATIENT STATUS: NO PATIENT INVOLVEMENT. INTERVENTION: INCOMING INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14645476 ↗
• MalfunctionJun 18, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA. DETAILED DESCRIPTION OF EVENT: "HAIR FOUND IN STERILE PACKAGING - DID NOT REACH PATIENT, DETECTED PRIOR TO PROCEDURE." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 02MAY2021 FROM [NAME]: THE CORRECT LOT NUMBER IS REPORTED AS 1395785. "THE CUSTOMER HAS THE COMPLAINT SAMPLE BUT DOES NOT THINK IT IS COST EFFECTIVE TO RETURN. THE CUSTOMER WOULD PREFER TO SEND AN IMAGE OF THE COMPLAINT SAMPLE SO THAT IT CAN BE DISCARDED AFTERWARD." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 03MAY2021 FROM [NAME]: PHOTOGRAPH WAS PROVIDED. PATIENT STATUS: NOT PATIENT INVOLVEMENT. TYPE OF INTERVENTION: NA-DETECTED PRIOR TO PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12029107 ↗