Kii® Optical Access system CTR33Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00607915124236), received between Apr 29, 2016 and Jan 3, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2025Fracture; Fracture

  PROCEDURE PERFORMED: LAP SUBTOTAL GASTRECTOMY. EVENT DESCRIPTION: RIGHT AFTER OPENING THE TROCAR PRODUCT, THE TROCAR OPTULATOR WAS BROKEN INTO TWO PARTS AND THEY REPLACED AND USED THE NEW PRODUCT. PRODUCT IS AVAILABLE FOR RETURN. TYPE OF 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 21074376 ↗
• MalfunctionNov 27, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  PROCEDURE PERFORMED: LAPAROSCOPIC BARIATRIC SURGERY. EVENT DESCRIPTION: DURING SURGERY, THE ENDOSCOPE DID NOT PASS SMOOTHLY THROUGH THIS TROCAR AND FELT SOMEWHAT STUCK. THE USER PREVIOUSLY REPORTED A SIMILAR ISSUE IN CASE CER (B)(4) LAST YEAR. RECENTLY, THEY HAVE FREQUENTLY ENCOUNTERED THE SAME ISSUE WITH THE CTR33 MODEL, THOUGH NO FORMAL COMPLAINT WAS FILED UNTIL NOW. SINCE THE USER CANNOT RECALL THE EXACT DATES OF EACH OCCURRENCE, THEY ARE UNABLE TO PROVIDE A DETAILED LIST. FOR NOW, THEY WILL FOCUS ON RETURNING THE DEFECTIVE PRODUCT AS A REFERENCE FOR THIS ISSUE. THERE IS NO IMPACT TO PATIENT. THE USER WAS UNABLE TO RESOLVE THE ISSUE AND HAD TO CONTINUE USING THE DEVICE DESPITE THE DIFFICULTY. THE PROBLEM WAS ONLY RESOLVED AFTER SWITCHING TO ANOTHER TROCAR. THERE IS NO OTHER INSTRUMENTS TO EFFECT THIS EVENT. ADDITIONAL INFORMATION PROVIDED BY THE DISTRIBUTOR ON 15NOV2024 VIA EMAIL: THE OBTURATOR WAS TOO LOOSE WITHIN THE CANNULA. YES, THERE IS RESISTANCE WHEN MOVING THE OBTURATOR IN AND OUT OF THE CANNULA. IT'S NOT POSSIBLE TO DETERMINE ANY DAMAGE FROM AN EXTERNAL INSPECTION. INTERVENTION: THE USER WAS UNABLE TO RESOLVE THE ISSUE AND HAD TO CONTINUE USING THE DEVICE DESPITE THE DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20793364 ↗
• MalfunctionNov 20, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: HYSTERECTOMY EVENT DESCRIPTION: WHILE TRYING TO USE IT FOR HYSTERECTOMY, THE CANNULA AND KII SEAL HOUSING DID NOT SEPARATE WELL, SO THEY TRIED TO FORCIBLY SEPARATE THEM AND IT BROKE. AFTER THAT, THE SURGERY WAS PROCEEDED WITH THE NEW PRODUCT. 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 20736365 ↗
• MalfunctionJun 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: CLEAR FOREIGN BODY FOUND IN PATIENT. EVENTUALLY WE DEDUCED THAT IT WAS A CLEAR SEAL PART OF THE PORT THAT PUSHED THROUGH PORT WHEN SURGEON WAS CLEANING PORT. SMALLER PORT HEAD IS INCLUDED AS IT WAS OPENED TO COMPARE AND ALLOWED US TO IDENTIFY THE PIECE WAS FROM ORIGINAL PORT OPENED. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570752 ↗
• MalfunctionJul 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC INGUINAL HERNIA. EVENT DESCRIPTION: DURING THE SURGICAL LAPAROSCOPIC OPERATION THE PLASTIC WHITE RING OF THE TROCAR DROPPED INSIDE THE ABDOMEN THE SURGEON FOUND THIS OUT AT THE END OF THE SURGERY WHILE HE PERFORMED A THOROUGH CHECKING BEFORE CLOSING THE PATIENT. THE RISK FOR THE RING TO REMAIN INTO THE PATIENT WAS VERY HIGH. INTERVENTION: COMPONENT RECOVERED. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12150842 ↗
• MalfunctionSep 2, 2020Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UTERINE FIBROID SURGERY. EVENT DESCRIPTION: IN PREPARATION FOR THE SURGERY, PLASTIC WAS BROKEN AT THE CONNECTION AREA TO CHECK AND REPLACED NEW CTR33 AND COMPLETED OPERATIONS. INTERVENTION: REPLACED NEW CTR33 AND COMPLETED OPERATIONS. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10483031 ↗
• MalfunctionJan 22, 2019Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC ADRENALECTOMY. EVENT DESCRIPTION: AIR SEAL PART INSIDE OF THE HANDLE WAS SEPARATED FROM THE TROCAR INTO PATIENCE ABDOMINAL CAVITY DURING THE SURGERY. LUCKILY IT WAS DETECTED BY SURGEON AND TAKEN OUT FROM THE PATIENT BODY. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM COUNTRY MANAGER, 7JAN2019 IT SEEMS TORN PARTS FALL INTO PATIENT' ABDOMINAL CAVITY AND LUCKILY SURGEON IDENTIFIES PARTS AND REMOVED SAFELY. THE FALL PARTS ARE BOTH WHITE AND BLACK. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM COUNTRY MANAGER, 7JAN2019 THE INCIDENT HAPPENED ONCE. SURGEON IS JUST COMPARING WHAT IS NORMAL ONE AND TRIED TO SHOW WHAT HAPPENED. HE ASKED NURSE TO OPEN A NEW DEVICE. INTERVENTION: DETECTED BY SURGEON AND TAKEN OUT FROM THE PATIENT BODY. PATIENT STATUS: NORMAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8267988 ↗
• MalfunctionJan 16, 2018Melted; Melted

  PROCEDURE PERFORMED: SALPINGECTOMY FOR ECTOPIC PREGNANCY. EVENT DESCRIPTION: "IT WAS REPORTED THAT THIS WAS A HIGH BMI CASE WITH A SMALL WORKING SPACE. INSUFFLATION WAS FLUCTUATING. TROCAR WAS SLIGHTLY INSIDE THE PATIENT AND A [ENERGY INSTRUMENT] WAS INSIDE THE TROCAR FIRING. THE TROCAR MELTED. ONCE THE ISSUE WAS DISCOVERED THE TROCAR WAS INSPECTED FOR ANY FRAGMENTATION. THE ROOM CONFIRMED NOTHING WAS LEFT IN THE PATIENT AND SINCE THE CASE WAS 95% COMPLETED WE FINISHED THE CASE AND REMOVED THE TROCAR AS SOON AS POSSIBLE." TYPE OF INTERVENTION: "SINCE THE CASE WAS 95% COMPLETED WE FINISHED THE CASE AND REMOVED THE TROCAR AS SOON AS POSSIBLE." PATIENT STATUS: FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7195257 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  HYSTERECTOMY- "TWO BIG PIECES OF RUBBER GOT LOOSEN FROM SEAL." PATIENT STATUS: UNHARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372802 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  LAPAROSCOPIC CHOLECYSTECTOMY - "THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO: (B)(4). THE EVENT UNIT WITH A REMOVED DDB AND A FRAGMENT WILL BE RETURNED TO AMR. PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION." COMPLAINT SHEET - "THE SEPTUM WAS DAMAGED AND LOST A PORTION LIKELY WHEN INSERTED A CLIP DURING LAPAROSCOPIC CHOLECYSTECTOMY. THE MISSING PORTION WAS RETRIEVED WITH NO PATIENT INJURY. THE PHYSICIAN STATES HE/SHE DIDN?T FEEL EXCESSIVE RESISTANCE WHICH COULD HAVE CAUSED THE INCIDENT DURING INSERTION. COMBINED INSTRUMENTS: HEMOCLIP, HARMONIC ACE, DISSECTOR, GAUZE. THE EVENT UNIT WITH A REMOVED DDB AND A FRAGMENT WERE RETURNED TO OLYMPUS AND VISUALLY INSPECTED. THE SEPTUM HAD A MISSING PORTION THAT MATCHED THE FRAGMENT IN SHAPE. THE FRAGMENT MEASURED APPROX. 7.5 MM X 8.7 MM. THE DDB HAD A TEAR AND IT WAS NOT RELATED TO THE INCIDENT AS IT WAS MADE WHEN THE DDB WAS CUT OFF FOR CHECKING THE CONDITION OF THE SEPTUM. THE UNIT AND THE FRAGMENT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. ADMIN#: (B)(4)." PATIENT STATUS - NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372200 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  LAPAROSCOPIC CHOLECYSTECTOMY- "FRAGMENT OF BLACK COLORED PLASTIC (3 X 3MM) WAS NOTED IN THE PATIENT'S ABDOMINAL CAVITY DURING THE LAPAROSCOPIC CHOLECYSTECTOMY. THE FRAGMENT WAS TAKEN OUT BY SURGEON BEFORE CLOSURE OF WOUND." PATIENT STATUS- NO DAMAGE TO PATIENT. PATIENT STATUS - NO DAMAGE TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370271 ↗
• MalfunctionNov 9, 2016Material Fragmentation; Material Fragmentation

  OVARY CYSTCY - "CLIENT SET UP THIS DEVICE TO PATIENT BODY. THEY USE SCOPE AND SEE A SMALL FRAGMENT OF TROCAR IN PATIENT BODY. THE FRAGMENT WAS MOVED FROM PATIENT BODY. PATIENT STATUS : "FINE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6090187 ↗
• MalfunctionMay 13, 2016Leak/Splash; Leak/Splash

  LAP DIAGNOSTIC - "WHEN O2 IS CONNECTED TO STOPCOCK AND STOPCOCK OPEN TO LET O2 IN - THEN THE O2 LEAKS RAPIDLY OUT OF THE TROCAR."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5654915 ↗
• MalfunctionMay 12, 2016Air Leak; Air Leak

  LAP SCOPE DIAGNOSIS - "TROCAR LEAKED AIR WHEN THEY PUT IT IN." PATIENT STATUS - N/A.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5651819 ↗
• MalfunctionMay 12, 2016Air Leak; Air Leak

  LAPAROSCOPIC GYNECOLOGICAL SURGERY - "AIR LEAK". PATIENT STATUS - "FINE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5651757 ↗
• MalfunctionApr 29, 2016Air Leak; Air Leak

  TUBAL LIGATION - "AIR LEAK. THIS SEAL WAS LOOSE FROM CANNULA." PATIENT STATUS - "FINE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5620146 ↗