Kii SleeveRecalls & reported problems across all models

We found 7 models of Kii Sleeve by Applied Medical Resources Corporation in the FDA's device registry (GUDID). Together they are named in 130 adverse event reports in the FDA's MAUDE database, received between Feb 10, 2016 and Sep 16, 2026 — classified as 130 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (67 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Kii Sleeve problems

Kii Sleeve models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Kii® Sleeve CTS22

  Laparoscope, General & Plastic Surgery
  49 reports
• Kii Sleeve CFS22

  Laparoscope, General & Plastic Surgery
  25 reports
• Kii Sleeve CFS02

  Laparoscope, General & Plastic Surgery
  17 reports
• Kii Sleeve CFS12

  Laparoscope, General & Plastic Surgery
  16 reports
• Kii® Sleeve CTS02

  Laparoscope, General & Plastic Surgery
  11 reports
• Kii® Sleeve CTS12

  Laparoscope, General & Plastic Surgery
  11 reports
• Kii Sleeve CFS03

  Laparoscope, General & Plastic Surgery
  1 report

Recent Kii Sleeve adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793072 ↗
• MalfunctionFeb 20, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC SIGMOIDECTOMY EVENT DESCRIPTION: THE CONSULTANT NOTICED A CLEAR PLASTIC RING INSIDE THE PATIENT UPON HIS FINAL CHECK BEFORE CLOSING UP, HE DID NOT NOTICE WHEN THIS MAY HAVE COME LOSE, THEREFORE IT IS NOT CLEAR WHEN THE INCIDENT OCCURED. HE DID NOTICE THAT THE TROCAR WAS POTENTIALLY LEAKING GAS WHILST INSTRUMENTS WERE INSIDE IT TOWARDS THE LATTER END OF THE SURGERY HOWEVER DID NOT REPLACE IT. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 05FEB26: NO PHOTOS/VIDEOS AVAILABLE. THE ENTIRE COMPONENT HAS FALLEN OUT AS A WHOLE. ALL THE PIECES WERE RETRIEVED FROM THE PATIENT. NO INTERNAL SEAL COMPONENTS REMOVED OR CUT IN ORDER TO INSPECT THE DAMAGED COMPONENT. INSTRUMENTATION THAT PASSED THROUGH THE EVENT UNIT: STAPLER, HARMONIC ENERGY DEVICE, GRASPER, SWABS, SUCTION. INTERVENTION: NOT APPLICABLE, IT WAS AT END OF THE SURGERY SO THEY DID NOT REPLACE IT. PATIENT STATUS: PATIENT IS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402788 ↗
• MalfunctionJan 21, 2026Material Fragmentation

  PROCEDURE PERFORMED: BILATERAL LASH WITH SALPINGECTOMY. EVENT DESCRIPTION: INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE, VIA PATIENT COMPLAINT FORM, ON 07JAN2026: [TRANSLATION] DURING A BILATERAL SALPINGECTOMY ON (B)(6) 2025, THE FOLLOWING SITUATION OCCURRED: WHEN INSERTING THE MORCELLATOR TO REMOVE THE SPECIMEN, THE MORCELLATOR SPIKE TOUCHED THE UMBILICAL TROCAR THROUGH WHICH THE LAPAROSCOPE WAS INSERTED. (A.E. DUE TO A MATERIAL DEFECT) THE PLASTIC BROKE INTRAOPERATIVELY, CAUSING A SMALL DEFECT IN THE TROCAR. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE, VIA EMAIL, ON 16JAN2026: NO ADDITIONAL INFORMATION BESIDES PRODUCT IS RETURNING. PATIENT STATUS: NO PATIENT INJURY NOR ILLNESS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133734 ↗
• MalfunctionDec 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC INGUINAL HERNIA SURGERY WHERE A MESH NEEDED TO BE PLACED. EVENT DESCRIPTION: THE PORTHOUSE (SEAL HOUSE) BROKE WHEN A MESH WITH A GRASPER WAS PLACED THROUGH THE PORTHOUSE (SEAL HOUSE). THE BLACK AND CLEAR INSTRUMENT SEAL FALL OUT AND INTO THE PATIENTS ABDOMEN. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 08DEC2025: TM CONFIRMED 'PORTHOUSE' MEANS SEAL HOUSE. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 15DEC2025: THE PATIENT IS OK AND THE SLEEVE WAS REPLACED. BESIDES THE LAPAROSCOPIC GRASPER, NO OTHER INSTRUMENTS WAS USED AT THE TIME OF THE INCIDENT ¿ BUT A MESH WAS BEING PLACED WITH THE GRASPER. ALL PIECES RETRIEVED FROM THE PATIENT WHICH WAS BLACK AND CLEAR IN COLOUR. THE COMPONENT FELL OUT AS A WHOLE. COMPONENTS WERE INSTRUMENT SEAL BLACK AND CLEAR AND DOUBLE DUCKBILL SEAL. NO INTERNAL SEAL COMPONENTS REMOVED OR CUT IN ORDER TO INSPECT THE DAMAGED COMPONENT. INTERVENTION: THE SLEEVE WAS REPLACED. PATIENT STATUS: OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885329 ↗
• 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 ↗
• MalfunctionAug 18, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: OOPHORECTOMY. EVENT DESCRIPTION: ON WEDNESDAY, (B)(6) 2025, DURING SURGERY ON PATIENT [NAME], PERFORMED BY DR. [NAME], A STRUCTURAL DEFECT WAS DETECTED IN ONE OF THE 12 MM TROCARS IN THE KIT. ONE OF THE TIPS BROKE AFTER THE SURGERY BEGAN, REMAINING DANGLING FOR APPROXIMATELY 30 MINUTES BEFORE FINALLY FALLING INTO THE PATIENT'S ABDOMINAL CAVITY. ADDITIONAL INFORMATION OBTAINED FROM DISTRIBUTOR ON 30JUL2025: THE BEND/BREAK DID NOT CAUSE PARTICULATION. IT WAS IDENTIFIED DURING USE; IT WAS INSIDE THE PATIENT'S CAVITY WHEN A PART DETACHED. THE TROCAR WAS INSERTED BY TURNING. THERE WAS NOT DIFFICULTY DURING INSERTION. THE TROCAR WAS NOT USED WITH A ROBOT. THE OBTURATOR WAS NOT INSERTED IN THE CANNULA AT THE TIME OF THE INCIDENT. ADDITIONAL INFORMATION OBTAINED FROM DISTRIBUTOR ON 30JUL2025: THEY DID REMOVE THE PIECE THAT HAD FALLEN INTO THE ABDOMEN. INTERVENTION: THEY USED ANOTHER TROCAR OF THE SAME BRAND. PATIENT STATUS: PATIENT IS IN NORMAL CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834529 ↗
• MalfunctionJun 25, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC RIGHT COLECTOMY. EVENT DESCRIPTION: [TRANSLATION] AT THE START OF THE PROCEDURE, THE SURGEON SAW A PIECE OF TROCAR IN THE PATIENT'S ABDOMEN. THE SURGEON RETRIEVED THE PIECE WITH DIFFICULTY AND ALMOST PERFORMED AN EXPLORATORY LAPAROTOMY. CUSTOMER ALSO SUBMITTED A COMPLAINT EMAIL/FORM VIA THE TM. [TRANSLATION] THE SURGEON NOTED THE PRESENCE OF A FOREIGN BODY IN THE ABDOMEN. THIS FOREIGN BODY TURNED OUT TO BE A PIECE OF TROCAR THAT HAD BECOME DETACHED. THE SURGEON REMOVED THE FOREIGN BODY, BUT HE HAD DIFFICULTY BECAUSE IT HAD MOVED INTO THE SMALL INTESTINE AND ALMOST HAD TO PERFORM AN EXPLORATORY LAPAROTOMY TO FIND THE ELEMENT. INTERVENTION: THE SURGEON RETRIEVED THE PIECE WITH DIFFICULTY AND ALMOST PERFORMED AN EXPLORATORY LAPAROTOMY. PATIENT STATUS: OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330413 ↗
• MalfunctionJun 25, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: NA (BEFORE USE). EVENT DESCRIPTION: WHILE OPENING THE PACKAGE, BROKEN FRAGMENTS WERE FOUND INSIDE THE STERILE POUCH. THERE IS NO IMPACT TO PATIENT. INTERVENTION: USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. PATIENT STATUS: NO PATIENT STATUS PROVIDED, EVENT OCCURRED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329680 ↗
• MalfunctionJun 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP. CHOLECYSTECTOMY. EVENT DESCRIPTION: DURING A CHOLECYSTECTOMY OPERATION, WHILE USING A 5 MM TROCAR FROM THE COMPANY APPLIED (REF: CFS02; LOT: 1512242; EXP: 20.12.2026), THE SURGEON (NAME REDACTED) NOTICES THAT THE TROCAR NO LONGER HOLDS THE GAS RETURN. HOWEVER, HE CONTINUES TO WORK UNTIL HE SEES THE TRANSPARENT PLASTIC VALVE PROTRUDING INTO THE ABDOMEN. IMMEDIATELY, BEFORE LOSING IT BETWEEN THE INTESTINAL LOOPS, THE VALVE IS FISHED OUT. INTERVENTION: THE VALVE IS FISHED OUT. PATIENT STATUS: OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22199078 ↗
• MalfunctionJun 2, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC ROUX-EN-Y. EVENT DESCRIPTION: COMPLAINT DESCRIPTION SENT TO ACCOUNT MANAGER FROM HOSPITAL REPRESENTATIVE: ONE OF THE 12MM TROCARS BROKE DURING THE CASE AND COULD OF CAUSED POTENTIAL HARM TO THE PATIENT. THE SNAP ON THE ONE SIDE OF THE TOP BROKE OFF DURING THE CASE. I UNFORTUNATELY DON'T HAVE THE ORIGINAL PACKAGING OF THIS PRODUCT BUT ALL THE LOT NUMBERS FOR THIS PRODUCT EITHER CORRELATE WITH EITHER THE 12MM WITH OBTURATOR OR JUST THE 12MM SLEEVE. THE ACCOUNT MANAGER CONFIRMS THAT ONE TROCAR MALFUNCTIONED, BUT THE HOSPITAL DOES NOT KNOW WHICH LOT NUMBER BELONGED TO THE COMPLAINT DEVICE. THE TWO TROCARS USED IN THE PROCEDURE: 1519454 AND 1541901. ADDITIONAL INFORMATION OBTAINED FROM HOSPITAL REPRESENTATIVE ON 16MAY2025: HOSPITAL CONTACT CONFIRMS THAT THE PIECE THAT FELL OFF WAS "THE CLIP TO THE WHITE TOP OF THE TROCAR". THE PIECE WAS RETRIEVED AND ACCOUNTED FOR. INTERVENTION: NEW TROCAR OBTAINED, PROCEDURE COMPLETED. PATIENT STATUS: PATIENT IS DOING WELL, NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127560 ↗
• MalfunctionMay 27, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: COELIO LAPAROSCOPIC. EVENT DESCRIPTION: REPORT WAS RECEIVED VIA NCA REF NUMBER (B)(4). [TRANSLATION] WHEN THE 10 TROCAR IS REMOVED, IT IS OBSERVED THAT THE TIP IS BROKEN. PCF FORM WAS SUBMITTED VIA TM WITH NO NEW INFO ON 15MAY25. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 28MAY25: THERE WAS NO PATIENT INJURY AND PATIENT IS OK, CONCOMITANT DEVICES WINDOW CLAMP. THE TROCAR WAS INSERTED WITH ROTATION MOVEMENT WITH NO DIFFICULTY DURING INSERTION. THE BREAK DID CAUSE PARTICULATION AND ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE TROCAR WAS NOT USED WITH A ROBOT. INTERVENTION: SEARCH FOR INTRAPERITONEAL TROCAR END. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22092461 ↗
• 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 ↗
• MalfunctionJan 8, 2025Fracture; Fracture

  PROCEDURE PERFORMED: THORACOSCOPY. EVENT DESCRIPTION: COMPLAINT 1 OF 2: (B)(4) (MFR # 2027111-2025-00312). COMPLAINT 2 OF 2: (B)(4) (MFR # 2027111-2025-00311). [TRANSLATION] I HAVE JUST RECEIVED A BAG FROM THE OPERATING THEATRE OF THE VISCERAL SURGERY DEPARTMENT AND IT CONTAINS (B)(4) TROCARS INCLUDING PACKAGING. IN BOTH CASES, THE ITEM IS CTB71 WITH AN IDENTICAL LOT NUMBER (1514503) AND IN BOTH CASES THE TROCAR IS BROKEN AT THE SHAFT. IT ALL HAPPENED DURING A PATIENT, I.E. AN OPERATION, AND THE SURGEON WAS MORE THAN EXPERIENCED (HEAD PHYSICIAN OF THE DEPARTMENT WITH SENIOR PHYSICIAN AS ASSISTANT). I HAVE SENT A MAKESHIFT PHOTO AND YOU CAN ROUGHLY RECOGNISE THE FRACTURE LINES. THE (B)(6) ALSO SUBMITTED AN EMAIL SUMMARIZING THE EVENTS MENTIONED BY THE HEALTHCARE USER AFTER SHE HAD COMMUNICATION WITH THE HEALTHCARE USER. SHE DID STATE THE PATIENT WAS GOOD. ADDITIONAL INFORMATION RECEIVED VIA THE CUSTOMER VIA (B)(6) LATER ON 30DEC 2024: THE (B)(6) STATED NEW INFORMATION WAS RECEIVED, IT SEEMS THERE WERE TWO DIFFERENT TROCARS WITHIN THE SAME PROCEDURE. THE CUSTOMER STATED THE FOLLOWING: [TRANSLATION] UNFORTUNATELY, THE WHOLE EVENT WAS A BIT MORE COMPLICATED: THERE WERE TWO DIFFERENT TR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105389 ↗
• MalfunctionJan 7, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: DIAGNOSTIC LAP AND WASHOUT. EVENT DESCRIPTION: WE ARE CONTACTING ON BEHALF OF THE GYNAECOLOGY TEAM AT [HOSPITAL NAME] TO ALERT YOU TO A DISTRESSING INCIDENT WHERE PART OF YOUR CANNULA (KII SLEEVE - CFS22, LOT 1524049) BROKE DURING OUR LAPAROSCOPIC PROCEDURE AND SMALL FRAGMENT REMAINED IN THE ABDOMEN OF A PATIENT. WE WERE UNABLE TO LOCATE THIS DESPITE SIGNIFICANT EFFORTS. WE WOULD LIKE YOU TO BE AWARE FOR YOUR OWN INVESTIGATIONS AND QUALITY ASSURANCE. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21093297 ↗
• MalfunctionOct 21, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: PROSTATECTOMY. EVENT DESCRIPTION: THE APPLIED MEDICAL REPRESENTATIVE SPOKE TO THE SURGEON AND HE TOLD THEM THAT WAS HIS MISTAKE AS HE WAS PULLING OUT, THE INSTRUMENT PARTIALLY OPENED. THEY HAD TO DO THE REPORT TO THE HEALTH MINISTRY AS THEY COULD NOT FIND A SMALL PIECE OF THE TROCAR. THE PROCEDURE WAS ALREADY FINISHED WHEN THE INCIDENT OCCUR. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 15OCT24: IT WAS CONFIRMED IT WAS THE CANNULA THAT BROKE. THERE WAS NO PATIENT INJURY AND PATIENT IS OK. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 25OCT24: THE TERRITORY MANAGER SENT OVER THE REPORT THAT WAS SUBMITTED TO NCA BY CUSTOMER. IT WAS REPORTED TO THE ITALIAN NCA WITH THE FOLLOWING : COMPLETED THE RADICAL PROSTATECTOMY SURGERY WITH EXTRACTION OF THE TROCAR IT WAS EVIDENT THAT THE PLASTIC END OF THE SAME. ONE WAS ABLE TO RECOVER A FRAGMENT OF ABOUT 3 MM BUT COULD NOT RECOVER ANOTHER ONE OF EQUAL SIZE THAT REMAINED IN THE ABDOMINAL MUSCLE TISSUE. TYPE OF INTERVENTION: PROCEDURE WAS ALREADY FINISHED WHEN THE INCIDENT OCCUR. PATIENT STATUS: OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20496504 ↗

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