Kii® Sleeve CTS02Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00607915123499), received between Mar 1, 2016 and Aug 27, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 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.

• MalfunctionAug 27, 2025Fracture; Fracture

  PROCEDURE PERFORMED: LAPAROSCOPIC SALPINGECTOMY. EVENT DESCRIPTION: PRODUCT OBTURATOR BROKE OFF IN PATIENT. AS SURGEON WAS ATTEMPTING TO INSERT OUTER SLEEVE BENT. ADDITIONAL INFORMATION PROVIDED BY USER FACILITY VIA EMAIL ON 20AUG2025: ALL PIECES WERE RETRIEVED FROM THE PATIENT. PIECE BENT IN THE MIDDLE OF SHAFT; BROKEN IN MIDDLE OF OBTURATOR WHILE SURGEON WAS ATTEMPTING TO INSERT. 2 CANNULAS INSERTED PRIOR TO THE THIRD ONE THAT BROKE. THE TROCAR WAS INSERTED AS IT ALWAYS IS... YOU WOULD NEED TO ASK DR [NAME] IF HE FELT THERE WAS ANY DIFFICULTY DURING INSERTION. IT APPEARED TO BE A BIT MORE DIFFICULT THAT THE PREVIOUS 2 TROCAR INSERTIONS, BUT THAT'S JUST MY OBSERVATION. INTERVENTION: CASE RESOLVED BY DR [NAME] RETRIEVING THE BROKEN PIECE FROM THE PATIENT. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22905349 ↗
• MalfunctionDec 9, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NI. DETAILED DESCRIPTION OF EVENT WHEN THE ITEM WAS BEING UNPACKAGED AT THE START OF SURGERY, IT WAS NOTICED THAT THERE WAS A HAIR INSIDE THE POUCH. DUE TO IT BEING A BIOHAZARD, THE TECH PLACED THE TROCAR BACK IN THE PACKAGING AND ANOTHER, NEW TROCAR WAS USED TO COMPLETE THE CASE. PRODUCT IS AVAILABLE FOR RETURN. PATIENT STATUS: NA (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: THE DEVICE WAS PLACED BACK IN PACKAGE AND A NEW ONE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15953903 ↗
• MalfunctionSep 24, 2021Melted; Melted

  PROCEDURE PERFORMED: "LAPAROSCOPIC CHOLECYSTECTOMY WITH FIREFLY AND INTRAOPERATIVE CHOLANGIOGRAM" EVENT DESCRIPTION: PER MEDWATCH #(B)(4), RECEIVED VIA MAIL ON 21SEP2021: "A LAPAROSCOPIC PROCEDURE WAS BEING PERFORMED UTILIZING THE KII SLEEVE. THE PLASTIC SLEEVE MELTED IN TWO PIECES INSIDE THE PATIENTS BODY. ALL PIECES OF THE SLEEVE WERE RETRIEVED AND ACCOUNTED FOR. THE MELTED TROCAR PIECES WERE RETURNED TO THE MANUFACTURER FOR FAILURE ANALYSIS. IT IS SUSPECTED THAT THE INSTRUMENT BEING USED TO REMOVE SEVERAL ADHESIONS WAS BEING USED FOR AN EXCESSIVE PERIOD OF TIME DUE TO THE NUMBER OF LEGIONS PRESENT. THIS COULD HAVE CONTRIBUTED TO THE TROCAR MELTING. NO HARM CAME TO THE PATIENT OR HEALTHCARE PROVIDERS." ADDITIONAL INFORMATION RECEIVED FROM USER FACILITY VIA EMAIL ON 22SEP2021: THE CONCOMITANT DEVICE, SUSPECTED TO BE USED FOR AN EXCESSIVE PERIOD OF TIME TO REMOVE SEVERAL ADHESIONS WITH THE KII SLEEVE, WAS NOT ABLE TO BE SPECIFIED AND STAFF WERE UNABLE TO PROVIDE THAT INFORMATION AFTER MULTIPLE ATTEMPTS. THE MATERIALS MANAGEMENT TEAM STATED THAT THE DEVICE WAS RETURNED, HOWEVER NO TRACKING INFORMATION WAS SAVED. NO ADDITIONAL PICTURES OF THE DEVICE COULD BE PROVIDED SINCE THE DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530212 ↗
• MalfunctionSep 24, 2020Material Twisted/Bent; Material Twisted/Bent

  THE EVENT UNIT CONTAINED COMPONENTS FROM TWO DIFFERENT MODELS: COMPONENT 1 OF 2 (2027111 - 2020 - 00546), COMPONENT 2 OF 2 (2027111 - 2020 - 00565). EVENT DESCRIPTION: RECEIVED VIA MAIL, MEDWATCH UF/IMPORTER REPORT # (B)(4). "WHILE INSERTING THE TROCAR, IT BENT." EVENT OCCURRED IN JULY 2020. ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 27AUG2020 FROM USER FACILITY: THE EVENT DATE IS 15JUL2020. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 28AUG2020 FROM USER FACILITY: THE LOCATION OF THE BEND WAS ON THE MID SHAFT OF TROCAR. THE OBTURATOR WAS INSIDE THE CANNULA AT THE TIME OF THE INCIDENT. IT IS UNKNOWN IF THERE WAS DIFFICULTY WITH THE INSERTION. THE WHOLE PRODUCT WAS REPLACED. IT IS UNKNOWN HOW THE CASE WAS COMPLETED AFTER THE EVENT OCCURRED. THE UNIT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 17SEP2020 FROM APPLIED MEDICAL ACCOUNT MANAGER I: THE FACILITY IS RETURNING A OBTURATOR FROM A CTF03 OF LOT 1384278 AND A CANNULA FROM A CTS02 OF LOT 1383546. THEY WERE BOTH USED IN THE SAME CASE. THE REP WAS NOT ABLE TO CONFIRM IF THE PRODUCTS WERE USED TOGETHER IN THE CASE. INTERVENTION: THE WHOLE PRODUCT WAS REPLACED. PATIENT STATUS: NO ADVERSE EVENT REPORTED. REP

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10583794 ↗
• MalfunctionFeb 6, 2020Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC SIGMOIDECTOMY. EVENT DESCRIPTION: DURING ENTRY OF THE TROCAR, THE PERITONEUM WASN'T BEING PENETRATED BY THE OBTURATOR, SO THE SURGEON USED A GRASPER TO HELP GRASP THE DISTAL TIP OF THE TROCAR WHILE INSIDE OF THE PATIENT TO HELP THE TROCAR PENETRATE THROUGH THE PERITONEUM. DURING THIS PROCESS, THE TIP OF THE TROCAR BROKE OFF INTO THE PATIENT AND THE PIECE COULD NOT BE FOUND DURING THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL HEALTH SYSTEM MANAGER, VIA TELEPHONE, ON JANUARY 28TH, 2020: REP. WAS PRESENT FOR THE CASE. THE EVENT DATE WAS JANUARY 24TH, 2020. THE NAME OF THE PROCEDURE BEING PERFORMED WAS A LAPAROSCOPIC SIGMOIDECTOMY. THE OBTURATOR BEING USED WAS AN APPLIED MEDICAL OBTURATOR. IT HAS BEEN CONFIRMED THAT THE PIECE OF PLASTIC THAT BROKE OFF INTO THE PATIENT WAS THE TIP OF THE CANNULA. PER REP., THE PATIENT WAS NOTIFIED THAT A PIECE OF PLASTIC FROM THE CANNULA WAS LEFT IN THEIR BODY. TO COMPLETE THE CASE, THE SURGEON REPLACED THE CTS02 WITH ANOTHER ONE. THERE WAS NO PATIENT INJURY AND THE PRODUCT IS NOT EXPECTED TO RETURN AS IT WAS DISCARDED IMMEDIATELY AFTER USE. TYPE OF INTERVENTION: REPLACED WITH ANOTHER CTS02 TO COMP

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9677728 ↗
• MalfunctionJan 7, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: A SMALL PIECE OF METAL WAS FOUND INSIDE THE SLEEVE. LIMITED INFORMATION WAS AVAILABLE AT THE TIME OF REPORTING. AN EMAIL IS AVAILABLE THAT STATES THAT YES, THE PROBLEM COULD CAUSE HARM. ADDITIONAL INFORMATION FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON OCTOBER 3, 2019: GBMC REPORT OF PRODUCT FAILURE FORM PROVIDED: "SMALL PIECE OF METAL FOUND INSIDE TROCAR". YES, IN THE REPORTERS OPINION THE PROBLEM COULD CAUSE HARM TO EMPLOYEE OR PATIENT. TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9558255 ↗
• MalfunctionApr 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: BILATERAL OOPHORECTOMY. EVENT DESCRIPTION: THE TROCAR BROKE OFF AND A PIECE FELL INTO THE PATIENT'S ABDOMEN. THE PIECE WAS REMOVED USING GRASPERS. THE PIECE WAS CLEAR IN COLOR. THIS WAS A PIECE OF THE INNER SEAL. THEY WERE USING [AN ENERGY DEVICE] AT THE TIME OF THE EVENT. THIS OCCURRED AROUND THE MIDDLE OF THE PROCEDURE. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER APPLIED MEDICAL TROCAR. THERE WAS NO PATIENT INJURY. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA TELEPHONE ON 03/25/2019 AT 8:14AM FROM MATERIALS MANAGER: THE EVENT DATE WAS (B)(6) 2019 AND THE DISTRIBUTOR THAT THEY USED FOR THE TROCAR WAS []. PATIENT STATUS: NO PATIENT INJURY OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8501433 ↗
• MalfunctionJul 20, 2018Break; Break

  PROCEDURE PERFORMED: LAPROSCOPIC TUBAL. EVENT DESCRIPTION: MEDWATCH REPORT #"450040-2018-008" WAS RECEIVED VIA MAIL ON 26 JUN 2018: "DESCRIBE THE EVENT OR PROBLEM: REPORTED FROM THE OR THAT TIP OF KII SLEEVE TROCHAR 5 X 100MM BROKE OFF IN PATIENT'S ABDOMEN DURING LAPROSCOPIC TUBAL. THE SURGEON WAS UNABLE TO LOCATE THE BROKEN TIP IN THE ABDOMEN BY VISUAL SEARCHING OR AFTER AN ABDOMINAL X-RAY. IT WAS DETERMINED TO CLOSE THE PATIENT AFTER UNSUCCESSFUL THOROUGH ATTEMPTS TO FIND THE MISSING PIECE OF THE TROCHAR TIP." ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2018 FROM RISK MANAGER: "THE PATIENT WAS DISCHARGED STABLE." TYPE OF INTERVENTION: "THE SURGEON WAS UNABLE TO LOCATE THE BROKEN TIP IN THE ABDOMEN BY VISUAL SEARCHING OR AFTER AN ABDOMINAL X-RAY. IT WAS DETERMINED TO CLOSE THE PATIENT AFTER UNSUCCESSFUL THOROUGH ATTEMPTS TO FIND THE MISSING PIECE OF THE TROCHAR TIP." PATIENT STATUS: "THE PATIENT WAS DISCHARGED STABLE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7708289 ↗
• MalfunctionNov 14, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: "LAP JEJUNOSTOMY TUBE PLACEMENT." EVENT DESCRIPTION: THIS IS THE EXPLANATION FROM DR. ABOUT THE PROBLEM HE ENCOUNTERED: "5 MM TROCAR WITH A LOOSE PLASTIC PARTICLE, WHEN INSERTED INTO THE PATIENT LOOSE PARTICLE WAS IN PATIENT'S ABDOMEN. SEEN WITH LAPAROSCOPIC CAMERA AND REMOVED IMMEDIATELY BY SURGEON. NO HARM TO PATIENT. SURGEON REQUESTED REPORT TO MANUFACTURER NOTIFIED OF INCIDENT. SAFETY REPORT COMPLETED. TROCAR PACKAGED AND GIVEN TO MATERIALS MANAGEMENT STAFF TO FOLLOW UP WITH MANUFACTURER. TYPE OF INTERVENTION: "REMOVED IMMEDIATELY BY SURGEON." PATIENT STATUS: "NO HARM TO PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7028321 ↗
• MalfunctionOct 19, 2016Material Fragmentation; Material Fragmentation

  HAND ASSISTED LAPAROSCOPIC HEMICOLECTOMY - "DURING THE PROCEDURE THE DOCTOR FELT SOMETHING HARD IN THE ABDOMINAL CAVITY. HE LOOKED AROUND AND FOUND A CLEAR PIECE OF PLASTIC WHICH TURNED OUT TO BE THE INSTRUMENT SEAL FROM THE TROCAR. THE TROCAR IN QUESTION WAS PLACED IN THE UPPER LEFT QUADRENT OF THE ABDOMEN DURING THE PROCEDURE. THE DOCTOR WAS ABLE TO REMOVE THE PIECE OF PLASTIC FROM THE ABDOMEN. LAPAROSCOPIC GRASPERS AND A COTTON SWAB WERE THE ONLY INSTRUMENTS INSERTED INTO THE TROCAR." "THE ENTIRE SEAL CAME OUT." PATIENT STATUS - "THE PATIENT IS FINE, THERE WAS NO COMPLICATIONS WITH THEM FROM THIS INCIDENT." TYPE OF INTERVENTION - "THE DOCTOR WAS ABLE TO REMOVE THE PIECE OF PLASTIC FROM THE ABDOMEN."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6042423 ↗
• MalfunctionMar 1, 2016Break; Fracture; Break; Fracture

  "WHILE PLACING DISPOSABLE 5MM LAPAROSCOPIC TROCAR IN THE PATIENT THE TROCAR CRACKED AND HAD TO BE RETRIEVED FROM THE PATIENT. THE TROCAR AND BROKEN PIECE WAS RETRIEVED FROM PATIENT. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)." PATIENT STATUS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5471583 ↗