Kii® Optical Access System C0R39Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607915116446), received between Mar 2, 2017 and Jul 9, 2025 — classified as 5 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 9, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  PROCEDURE PERFORMED: GASTRIC SLEEVE. EVENT DESCRIPTION: THE SURGEON WAS USING VARIOUS APPLIED MEDICAL LAP INSTRUMENTS THROUGH THE SEAL. A PIECE OF SILICON FROM THE SEAL DISLODGED AS THE [COMPETITOR] GASTRIC STAPLER. NO CLINICAL IMPACT TO THE PATIENT. THE SURGEON HAD TO REMOVE THE PIECE OF SILICON FROM THE PATIENT'S ABDOMEN THEN PROCEEDED TO FINISH THE OPERATION. THE SURGEON ASKED FOR ANOTHER C0R39 AND REPLACED THE ORIGINAL ONE AS IT WAS LEAKING. [COMPETITOR] GASTRIC STAPLER WAS ALSO USED WHEN THE COMPLAINT EVEN OCCURRED. INTERVENTION: THE SURGEON HAD TO REMOVE THE PIECE OF SILICON FROM THE PATIENT'S ABDOMEN THEN PROCEEDED TO FINISH THE OPERATION. THE SURGEON ASKED FOR ANOTHER C0R39 AND REPLACED THE ORIGINAL ONE AS IT WAS LEAKING. PATIENT STATUS: FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460147 ↗
• MalfunctionAug 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: SLEEVE GASTRETOMY EVENT DESCRIPTION: DOCTOR [NAME] FOUND IT HAS LEAKAGE PROBLEM AFTER HE PULLING OUT THE CANNULA FROM TROCAR, FOLLOWED BY INSERTING 5 MM INSTRUMENT AND THEN HE DISCOVERED A PART OF THE SLEEVE (BLACK ONE) AND THE WHOLE TRANSPARENT SLEEVE WERE IN PATIENT ABDOMINAL. HE TOOK OUT THE 2 FALLING PARTS AND LET THE NURSE TO RESEMBLE IT, NO EXTRA FRAGMENTS WERE FOUND IN ABDOMINAL. PRODUCT RETURN EXPECTED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 08AUG2021 FROM USER FACILITY: A 5MM GRASPER WAS USED THROUGH THE TROCAR. TYPE OF INTERVENTION: HE USED ANOTHER TROCAR OF C0R39(SAME LOT, NEW ONE) AFTERWARD WITHOUT DEFECT THIS TIME. PATIENT STATUS: PROCEDURES WENT ON AFTER CHANGING FOR ANOTHER TROCAR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316641 ↗
• MalfunctionNov 12, 2020Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP GASTRIC SLEEVE. EVENT DESCRIPTION: DURING THE CASE THE SPECIMEN WAS ABOUT TO BE REMOVED FROM THE PORT SITE WITH A BAG, THE 15MM TROCAR WAS REMOVED AND THE SPECIMEN WAS REMOVED SUCCESSFULLY. THE SURGEON THEN NOTICED A SMALL BLACK OBJECT ON THE SCREEN. THE SURGEON THEN REMOVED TWO OBJECTS FROM THE PERITONEUM. THE REMOVED OBJECTS WERE COMPARED TO A NEW 15MM TROCAR TO CONFIRM IT HAD COME FROM THE USED C0R39. THE SURGEON WAS SATISFIED IT HAS BEEN REMOVED FROM THE PATIENT AND DID NOT REQUEST AN X-RAY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM APPLIED TEAM MEMBER ON NOVEMBER 5, 2020: I SPOKE WITH THE SURGEON REGARDING THIS INCIDENT THIS MORNING. HIS INCIDENT REPORT IS ATTACHED. FURTHER INFORMATION AS STATED BELOW IS THAT ¿LEAKING¿ WAS HEARD ON ENTRY OF AN INSTRUMENT. THE PORT WAS INSPECTED APPEARED OK BUT THEN IN REPLACING THE PORT AND INSERTING THE INSTRUMENT THE OBJECTS IN THE ABDOMEN WERE SEEN. THE INSTRUMENT BEING USED IN THE PORT WAS A [NON-APPLIED] BLACK STAPLER. INCIDENT REPORT RECEIVED VIA EMAIL FROM USER FACILITY ON 05NOV2020: AFTER I INTRODUCED AN INSTRUMENT THROUGH, THE VALVE STARTED LEAKING, I FULLY REMOVED THE PART AND COULD NOT SEE A PROBLEM, SO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10830030 ↗
• MalfunctionJun 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC RIGHT UPPER LOBECTOMY. EVENT DESCRIPTION: A TROCAR BROKE. NO PATIENT INJURY OCCURRED. LIMITED INFORMATION WAS AVAILABLE AT THE TIME OF REPORTING. ADDITIONAL INFORMATION RECEIVED VIA TELEPHONE FROM ACCOUNT MANAGER ON WEDNESDAY, 18APR2019: THE MODEL NUMBER IS C0R39. THE LOT NUMBER IS 1331889. THIS IS THE ONLY INFORMATION AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION RECEIVED VIA TELEPHONE ON 22APR2019 FROM ACCOUNT MANAGER: CASE WAS A ROBOTIC RIGHT UPPER LOBECTOMY. MULTIPLE INSTRUMENTS AND LARGE ROLLED PIECES OF GAUZE WERE PLACED THROUGH THE TROCAR. LARGE PIECES OF GAUZE WERE BEING PUT DOWN THE TROCAR AT THE TIME THE BLACK PIECE OF THE SEAL BROKE. IT WENT DOWN THE CANNULA AND INTO THE PATIENT. THE SEAL WAS RETRIEVED WITH A GRASPER AS SOON AS IT HAPPENED. OPENED A NEW TROCAR (SAME MODEL) AND CONTINUED THE CASE. TYPE OF INTERVENTION: RETRIEVED SEAL FROM THE PATIENT. OPENED A NEW TROCAR. PATIENT STATUS: NO PATIENT INJURY OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8717272 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED UNKNOWN - "DURING THE PROCEDURE, THE SURGEONS SAW A PIECE OF DARK-COLOURED MATERIAL INSIDE THE PATIENT AND REMOVED DURING THE SURGERY. AFTER EXAMINATION OF THE SPECIMEN (BLACK RUBBER), THEY FOUND THE SOURCE. IT CAME FROM THE INSIDE OF THE HEAD OF THE TROCAR. THE CUSTOMER HAS THE EVENT SAMPLE BUT CANNOT BE SENT TO (B)(4) BECAUSE OUR CURRENT PROCEDURES MEAN WE CANNOT ACCEPT CONTAMINATED PRODUCT INTO OUR FACILITY." PATIENT STATUS - "NO ADVERSE OUTCOMES REPORTED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372207 ↗