Kii® Sleeve CTS12Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00607915124267), received between Jun 24, 2016 and Mar 25, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: WHEN THE OBTURATOR WAS PUTTING INSIDE THE SLEEVE IT STOPPED AND DIDN´T GO IN. THE KII SLEEVE HAS NOT BEEN IN THE PATIENT. NO CLINICAL IMPACT ON PATIENT. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 02SEP2024: DEVICE MODE WAS CONFIRMED AS KII SLEEVE CTS12, LOT NUMBER: 1512222. INTERVENTION: THEY TOOK A NEW ONE. PATIENT STATUS: NO PATIENT STATUS PROVIDED; EVENT OCCURRED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21694015 ↗
• MalfunctionJul 26, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAP CHOLECYSTECTOMY. EVENT DESCRIPTION: "TROCAR 11 MM Z-THREAD WAS BEING USED IN A LAP CHOLE CASE. THE SURGEON WAS TRYING TO INSERT THE INTRODUCER THROUGH THE SLEEVE WHEN HE NOTICED A SMALL PLASTIC PART STUCK IN THE MIDDLE OF THE SLEEVE. HE WAS NOT ABLE TO REMOVE IT, SO ANOTHER SLEEVE WAS OPENED. NO CLINICAL IMPACT ON THE PATIENT". INTERVENTION: A NEW SLEEVE WAS OPENED PATIENT STATUS: NO CLINICAL IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19845085 ↗
• MalfunctionSep 11, 2023Break; Break

  PROCEDURE PERFORMED: LAP. SLEEVE GASTRECTOMY. EVENT DESCRIPTION: INSERTION OF THE TROCAR. TROCAR BROKE DURING INSERTION. DIFFERENT TROCAR WAS PROVIDED TO THE DOCTOR. INTERVENTION: DIFFERENT TROCAR WAS PROVIDED TO THE DOCTOR. PATIENT STATUS: ALIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17725636 ↗
• MalfunctionOct 25, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE A SMALL PIECE OF PLASTIC WAS SEEN AND RETRIEVED. THIS WAS LATER DISCOVERED TO BE FROM THE PORT ITSELF AND NOT FROM ANY OTHER INSTRUMENTATION. THE PIECE MATCHING THE PORT. TYPE OF INTERVENTION: PIECE OF PLASTIC WAS SEEN AND RETRIEVED. PATIENT STATUS: NO INJURIES NOTED BY THE SURGEON. NO HARM CAUSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6978600 ↗
• MalfunctionAug 22, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: THE BLACK PART INSIDE THE SEAL FELL IN THE PATIENT ABDOMEN THEN WAS SUCCESSFULLY RETRIEVED. THIS EVENT OCCURRED AT THE END OF THE SURGERY DURING EXSUFFLATION. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM USER FACILITY ON 03 AUGUST 2017: A 5MM BLACK PIECE OF A TROCAR VALVE HAS DETACHED IN THE PATIENT'S ABDOMEN. SEEN DURING EXSUFFLATION AT THE END OF THE INTERVENTION. TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6810294 ↗
• MalfunctionJun 15, 2017Material Fragmentation; Material Fragmentation

  ADDITIONAL INFORMATION RECEIVED VIA THE TELEPHONE AT 8:35AM FROM IMPLEMENTATION SPECIALIST ON (B)(4) 2017. THE DEVICE WAS DISCARDED BY THE FACILITY AND NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION REGARDING THE EVENT IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6644196 ↗
• MalfunctionMay 26, 2017Material Fragmentation; Material Fragmentation

  LAPAROSCOPIC CHOLECYSTECTOMY - TOWARDS THE END OF THE PROCEDURE THE CONSULTANT NOTICED SOME OF THE BLACK SEAL HOUSING IN THE PATIENT. HE IS UNSURE WHEN THE BLACK RUBBER PIECE OF THE SEAL HOUSING ACTUALLY TORE OFF. OTHER PRODUCTS USED DOWN THIS PORT, APART FROM THE NORMAL 5 MM INSTRUMENTS, WAS A [NON-APPLIED] CLIP APPLIER WITH A PURPLE CLIP. THE SEAL HOUSING IS BEING KEPT FOR APPLIED MEDICAL COLLECTION. THE BLACK PORTION OF THE RUBBER SEAL HOUSING WAS REMOVED PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6596113 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  LAPAROSCOPIC CHOLECYSTECTOMY- "DR. (B)(6) IS USING THE KII TROCARS SINCE MANY YEARS. TODAY HE USED DIFFERENT 5MM AND 10MM INSTRUMENTS. DURING THE PROCEDURE, DR. (B)(6) PLACED A CLIP OVER THE CYSTIC DUCT. IN THIS MOMENT HE SAW A SMALL PART OF RUBBER SEAL BETWEEN THE DUCT AND THE CLIP. HE PLACED ANOTHER CLIP AND REMOVED THE CLIP WITH THE BLACK RUBBER. HE ASKED FOR ANOTHER SEAL AND EVERYTHING WORKED FINE." PATIENT STATUS - OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370269 ↗
• MalfunctionMar 1, 2017Break; Break

  PROCEDURE PERFORMED UNKNOWN- "DURING INTRODUCTION OF THE DEVICE, THE SLEEVE GOT BROKEN IN THE MIDDLE OF THE THREADED PART. THE BROKEN PART OF THE DEVICE STAYED ATTACHED TO THE TROCAR. NOTHING FELL INSIDE THE PATIENT." PATIENT STATUS: OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370239 ↗
• MalfunctionOct 20, 2016Material Fragmentation; Material Fragmentation

  LAPAROSCOPIC PANCREATECTOMY -: "SURGEON NOTICED THAT WHEN HE CAME TO USE THE CLIP APPLIER IT HAD A PIECE OF BLACK RUBBER LODGED ON THE CLIP APPLIER, SURGEON REMOVED THE CLIP APPLIER AND THE CTS12 PORT. HE INSERTED A NEW CTS12 TO FINISH OF THE PROCEDURE WHERE THERE WERE NO FURTHER PROBLEMS . THE TEAM PACKAGED THE PORT AND PIECE OF RUBBER READY FOR IT TO BE RETURNED TO APPLIED MEDICAL." PATIENT STATUS - RECOVERED IN THE WARD AND WAS DISCHARGED. TYPE OF INTERVENTION - N/A.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6045991 ↗
• MalfunctionJun 24, 2016Material Fragmentation; Material Fragmentation

  LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY (LAVH) - "A PIECE OF THE RUBBER SEAL BECAME LOOSE AND DROPPED INTO THE ABDOMINAL CAVITY. WHEN USING THE LAPAROSCOPIC KNOT TYING DEVICE AND WHILE LOWERING/TIGHTENING THE KNOT, A PIECE OF RUBBER DROPPED INTO THE ABDOMINAL CAVITY." PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5749046 ↗