Kii Sleeve CFS02Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00607915117733), received between Jun 30, 2016 and Jun 12, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMay 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: AS THE SURGEON WAS PUTTING THE ASPIRATOR INTO THE TROCAR, THEY WERE PLACING IT INTO THE TROCAR AT AN ANGLE AND HAD TO PUSH IT DOWN THE TROCAR WITH SOME FORCE. WHILE PUSHING THE ASPIRATOR DOWN, THE ASPIRATOR DAMAGED THE CLEAR PLASTIC PIECE OF THE SEAL AND PUSHED IT DOWN THE CANNULA AND INTO THE PATIENT'S ABDOMEN. THE SURGEON PULLED THE PIECE OUT OF THE PATIENT'S ABDOMEN. THE PIECE WAS FULLY INTACT. THERE IS A SMALL SPLIT/HOLE WHERE THE ASPIRATOR POKED AND SHOVED IT DOWN, BUT THE PIECE IS STILL WHOLE. IT IS CONFIRMED THAT EVERYTHING WAS RETRIEVED FROM THE PATIENT'S ABDOMEN. THE SURGEON TRIED TO REPLICATE THE EVENT WITH A DEMO TROCAR AND ASPIRATOR, AND THE EVENT DID RECUR HOWEVER THE SURGEON HAD TO USE MUCH MORE FORCE DURING THIS DEMONSTRATION IN ORDER TO REMOVE THE CLEAR PLASTIC PART FROM THE SEAL. THE PRODUCT IS AVAILABLE FOR RETURN. TYPE OF INTERVENTION: PULLED THE PIECE OUT OF THE PATIENT'S ABDOMEN. PATIENT STATUS: PATIENT WAS OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19376850 ↗
• MalfunctionNov 7, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT [DISTRIBUTOR] INCOMING INSPECTION PO# (B)(4). THIS IS A COMPLAINT FROM [DISTRIBUTOR] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: SEPTEMBER 8,2023 PLEASE REFER TO THE ATTACHMENT FILE. WE FOUND DEFECTS AS THE RESULT OF INCOMING INSPECTION OF THE PRODUCTS. PLEASE REFER TO THE ATTACHMENT MATERIAL FOR THE QUANTITY WHICH RETURNS THE PRODUCTS. WE FOUND THE DEFECTS THAT ALREADY INFORMED APPLIED MEDICAL BY CER. WE JUST INFORM YOU THE DEFECT AND RETURN THE PRODUCTS FOR FOLLOWING DEFECTS. YOU DO NOT NEED INVESTIGATION. HAIRLIKE OBJECT IN POUCH - CFS02 LOT #1492330 (1 EA.). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: NA (INCOMING INSPECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088920 ↗
• MalfunctionAug 29, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: [DISTRIBUTOR] INCOMING INSPECTION PO (B)(4). THIS IS A COMPLAINT FROM [DISTRIBUTOR] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: JULY 7,2023. WE FOUND DEFECTS AS THE RESULT OF INCOMING INSPECTION OF THE PRODUCTS. WE FOUND THE DEFECTS THAT ALREADY INFORMED APPLIED MEDICAL BY CER. WE JUST INFORM YOU THE DEFECT AND RETURN THE PRODUCTS FOR FOLLOWING DEFECTS. YOU DO NOT NEED INVESTIGATION. HAIRLIKE OBJECT IN POUCH - CFS02 LOT #1491534 (1 EA.). TYPE OF INTERVENTION: NA (INCOMING INSPECTION). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17644404 ↗
• MalfunctionAug 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: REP WAS NOT PRESENT FOR THE CASE. WHEN THE RESIDENT INSERTED THE ASPIRATION NEEDLE INTO THE TROCAR THE CLEAR SEAL WAS PUSHED THROUGH THE BLACK SEALS AND INTO THE PATIENT. THE BLACK SEALS WERE ALSO PUSHED DOWN INTO THE PATIENT. THE PIECES WERE ABLE TO BE REMOVED. THERE WAS NO PATIENT INJURY. THE SURGEON USED ANOTHER PORT TO COMPLETE THE PROCEDURE. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 19JUL2023 FROM THE FACILITY: LAPAROSCOPIC INSTRUMENTS AND A SCOPE WERE USED WITH THE TROCAR. YES, INTERNAL SEAL COMPONENTS WERE CUT AFTER THE PROCEDURE. "IN ORDER TO SEE WHERE THE CLEAR VALVE CAME FROM THE OUTERMOST BLACK VALVE WAS CUT AFTER THE PROCEDURE AND REMOVED FROM THE TROCAR, AS WELL AS THE INNER BLACK VALVE." TYPE OF INTERVENTION: THE CASE WAS COMPLETED USING ANOTHER PORT. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17466677 ↗
• MalfunctionMar 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP. ADNEXECTOMY. EVENT DESCRIPTION: DURING THE OPERATION, A PUNCTURE NEEDLE WAS INSERTED THROUGH THE TROCAR AND PROBABLY PUSHED THE SEALING CAP PURELY INTO THE ABDOMINAL CAVITY. THERE WERE NO CHANGES IN HEALTH RESULTING FROM THE EVENT. THEY CUT THE SEAL IN TWO PIECES AND REMOVED IT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 21MAR23: THE CUSTOMER RETRIEVED ALL THE PIECES FROM THE PATIENT. PRIOR TO THE INCIDENT, THEY USED A GRASPING FORCEPS. INTERVENTION: THEY CUT THE SEAL IN TWO PIECES AND REMOVED IT. PATIENT STATUS: IS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16605852 ↗
• MalfunctionAug 3, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  PROCEDURE PERFORMED: HYSTERECTOMY EVENT DESCRIPTION: EVENT 1 OF 2: 2022-001975. EVENT 2 OF 2: 2022-001989. THE SURGEONS NOTED A "FORCED" PASSAGE OF THE NEEDLES MENTIONED IN THE CFS02 SLEEVE REF. AS A RESULT, THERE WAS NEEDLE RUBBING WITH THE PLASTIC OF THE SLEEVE. THE NEEDLES REMAINED STUCK IN THE TROCAR, SOME OF THEM LOOSENED DURING THE MANIPULATIONS. THIS TYPE OF EVENT OCCURRED TWICE IN 24 HOURS WITH 2 REFERENCES OF THE SLEEVE MENTIONED. NO UNIT OF THIS REFERENCE CFS02 WAS KEPT. NEEDLES USED :[BRAND NAME REDACTED] 2/0 AIGUILLE 31 MM 1/2C REF : JV3016 -[BRAND NAME REDACTED] 0 AIGUILLE 26 MM 1/2C REF : X905H. TYPE OF INTERVENTION: SURGEONS USED ANOTHER CFS02 LOT NUMBER AND EVERYTHING WENT WELL PATIENT STATUS: FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15160942 ↗
• MalfunctionAug 3, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  PROCEDURE PERFORMED: HYSTERECTOMY. EVENT DESCRIPTION: EVENT 1 OF 2: (B)(4). EVENT 2 OF 2: (B)(4). THE SURGEONS NOTED A "FORCED" PASSAGE OF THE NEEDLES MENTIONED IN THE CFS02 SLEEVE REF. AS A RESULT, THERE WAS NEEDLE RUBBING WITH THE PLASTIC OF THE SLEEVE. THE NEEDLES REMAINED STUCK IN THE TROCAR, SOME OF THEM LOOSENED DURING THE MANIPULATIONS. THIS TYPE OF EVENT OCCURRED TWICE IN 24 HOURS WITH 2 REFERENCES OF THE SLEEVE MENTIONED. NO UNIT OF THIS REFERENCE CFS02 WAS KEPT. NEEDLES USED :[BRAND NAME REDACTED] 2/0 AIGUILLE 31 MM 1/2C REF : JV3016 -[BRAND NAME REDACTED] 0 AIGUILLE 26 MM 1/2C REF : X905H. TYPE OF INTERVENTION: SURGEONS USED ANOTHER CFS02 LOT NUMBER AND EVERYTHING WENT WELL PATIENT STATUS: FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15160939 ↗
• MalfunctionNov 3, 2021Fracture; Material Fragmentation; Fracture; Material Fragmentation

  PROCEDURE PERFORMED: ENDOSCOPIC UMBILICAL HERNIA REPAIR EVENT DESCRIPTION: THE DR PERFORMED A ENDO UMBILICAL HERNIA REPAIR. APPARENTLY AFTER DEFLATING THE TROCAR WHEN THE PROCEDURE WAS COMPLETE, AND THEY TOOK THE SLEEVE OUT OF THE PATIENT THE TIP OF THE TROCAR BROKE OFF AND THE BALLOON DISINTEGRATED. ACCORDING TO THE SCRUB SISTER, THEY THINK THAT DURING THE PROCEDURE MAYBE THE DIATHERMY TOUCHED THE SLEEVE. TYPE OF INTERVENTION: FRAGMENTS WERE RETRIEVED PATIENT STATUS: THE PROCEDURE TIME WAS PROLONGED WITH 1 HOUR BECAUSE THEY HAD TO TAKE THE BALLOON FRAGMENTS AND PLASTIC OF THE SLEEVE OUT OF THE ABDOMEN OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12749095 ↗
• MalfunctionMar 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: EMERGENCY RE-LAPAROSCOPY FOR SMALL BOWEL OBSTRUCTION. EVENT DESCRIPTION: THE BLUE FLANGE FROM THE PORT WAS RETAINED IN THE SUBCUTANEOUS TISSUE OF THE PATIENT FOLLOWING REMOVAL OF THE PORT. THIS WAS NOT NOTED UNTIL 5 DAYS AFTER THE SURGICAL PROCEDURE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM APPLIED REGIONAL SALES MANAGER 02MAR21: THE PATIENT HAS BEEN DISCHARGED. THE COMPONENT WAS REMOVED FROM THE PATIENT. THEY ARE NOT AWARE OF ANY FURTHER CONSEQUENCES FOR THE PATIENT. THE PROCEDURE WAS PERFORMED ON (B)(6) 2021. THE COMPONENT WAS IDENTIFIED ON (B)(6) 2021. THE INITIAL PROCEDURE WAS AN EMERGENCY RE-LAPAROSCOPY FOR SMALL BOWEL OBSTRUCTION- SMALL BOWEL ADHERENT TO PELVIC FLOOR MESH. THE PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM APPLIED MEDICAL REP 09MAR21: THE CUSTOMER WILL RETURN ONLY THE BLUE FLANGE FROM THE CFS02, RETRIEVED IN THE PATIENT ABDOMEN, AS THE REST OF THE PRODUCT HAS BEEN DISPOSED OF BY CUSTOMER. TYPE OF INTERVENTION: THE COMPONENT WAS REMOVED FROM THE PATIENT. PATIENT STATUS: THE PATIENT HAS BEEN DISCHARGED. THE COMPONENT WAS REMOVED FROM THE PATIENT. THEY ARE NOT AWARE OF ANY FURTHER CONSEQUENCES FOR THE P

  Patient problems: Foreign Body In Patient

  MAUDE report 11407802 ↗
• MalfunctionJan 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPY. EVENT DESCRIPTION: LAPAROSCOPIC GYNAE PROCEDURE. 1 X 12MM & 2 X 5MM PORTS WERE USED. APPROX AN HOUR INTO THE CASE A 5MM PORT WASN'T MAINTAINING A GOOD SEAL. A FIRST ENTRY PORT WAS ALSO USED IN THE PROCEDURE. SURGEON SPOTTED AN OPAQUE PLASTIC CAP SITTING ON THE PATIENTS BOWEL BEFORE REMOVING THE PORTS. SHE WAS A LARGE LADY AND IT WAS LUCKY IT WAS DETECTED AND REMOVED AT THAT POINT. EMAIL WITH PHOTO OF THE CAP SENT TO APPLIED MEDICAL ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM USER FACILITY ON 10JAN2021 - CONFIRMING THE EVENT AND ALERT DATE WERE (B)(6). ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM APPLIED MEDICAL TEAM MEMBER ON JAN 11, 2021: FURTHER TO MY CONVERSATION EARLIER, JUST TO CONFIRM I HAVE VISITED [USER FACILITY] AND TAKEN THE ATTACHED PHOTOS WHILE [] (THEATRE MANAGER) AND [] COLLEAGUES DISMANTLED THE KII SLEEVE TO ENSURE THAT ONLY THE INSTRUMENT SEAL BECAME LOOSE DURING THE PROCEDURE AND NOT ANY PART OF THE DOUBLE DUCK BILL. I ALSO HAVE TAKEN VIDEO OF THE DISMANTLING BUT THESE ARE TOO LARGE TO SEND VIA EMAIL. THIS HAS PROVIDED REASSURANCE TO ALL CONCERNED THAT THERE IS NO RISK OF ANYTHING BEING LEFT IN THE PATIENT. PATIENT STATUS: NIL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11175227 ↗
• MalfunctionNov 6, 2019Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  MEDWATCH # MW (B)(4). DATE OF EVENT: (B)(6) 2018. PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: PROTECTIVE CAP PLACED OVER BALLOON; UNABLE TO BE USED WITHOUT RUPTURING BALLOON. PATIENT STATUS: UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9287945 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  LAP ANTERIOR. COLON RESECTION. TATME. - "NEARLY FINISHING THE PROCEDURE, WHEN THE SURGEON SEES A CLACK "RUBBER" SPOT INTRAABDOMINAL. NOTHING IS MISSING ON INSTRUMENTS. GUESS IT MIGHT BE A PIECE OF A TROCAR SEAL- BUT NOT SURE." PATIENT STATUS - PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6375147 ↗
• MalfunctionMar 2, 2017Physical Resistance; Physical Resistance

  LAPAROSCOPIC GASTRIC SLEEVE- "DURING TROCAR INSERTION OF FAR LEFT LATERAL PORT THE SURGEON READJUSTED THE ANGLE OF INSERTION. WITH TROCAR STILL PARTIALLY INSERTED THE SURGEON LIFTED UP ON THE TROCAR WHILE PUSHING DOWN ON THE SEAL HOUSING. CARRYING THE WEIGHT OF PATIENT'S PANNUS THE TROCAR CRIMPED IN HALF. THE PATIENT HAS A BMI OF (B)(6) AND HAS HAD MULTIPLE PREVIOUS SURGERIES INCLUDING OPEN APPY, OPEN CHOLE, AND MULTIPLE C/S." PATIENT STATUS: NORMAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372836 ↗
• MalfunctionMar 2, 2017Device Operates Differently Than Expected

  LAP CHOLE- "SURGEON EXPERIENCED ABNORMALLY HIGH DRAG WHEN USING CLIP APPLIER IN ADVANCED FIXATION TROCAR. SURGEON WAS USING CFS02 AT THE EPIGASTRIC PORT FOR CHOLANGIOGRAM PLACEMENT. THERE WAS ENOUGH DRAG THAT SURGEON COULD NOT ARTICULATE TO SECURE CATHETER. HE REQUEST ETHICON LIGAMAX 5 TO COMPLETE THE CASE. THE TROCAR IN USE IS ALSO BEING RETURNED. THE MODEL # IS CFS02. THE LOT NUMBER IS 1218613. ONE EACH." PATIENT STATUS: UNAFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372825 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  LOW. ANTERIOR. COLON RESECTION. TATME - "NEARLY FINISHED THE PROCEDURE, THE SURGEON SAW A BLACK "RUBBER" SPOT INTRA-ABDOMINAL. NOTHING IS MISSING ON INSTRUMENTS. GUESS, IT MIGHT BE A PIECE OF A TROCAR SEAL- BUT NOT SURE." PATIENT STATUS - PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370265 ↗
• MalfunctionJun 30, 2016Misassembly by Users; Misassembly by Users

  "THIS IS A COMPLAINT FROM THE MARKET. (B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION." REPORT FROM THE SALES REP - THE PROTECTIVE CAP WAS NOT REMOVED FROM CANNULA DURING PRE-USE CHECK BEFORE PROCEDURE. INITIAL INVESTIGATION REPORT BY (B)(4) OLYMPUS -THE ACTUAL EVENT UNIT WAS RETURNED TO OLYMPUS AND VISUALLY INSPECTED. CONFIRMED THE CAP WAS BETWEEN BALLOON AND DISK. THE EVENT UNIT WILL BE RETURNED TO APPLIED MEDICAL FOR FURTHER EVALUATION. PLEASE ANALYZE THIS COMPLAINT PHENOMENON AND REVIEW THE DEVICE HISTORY RECORD OF THE EVENT UNIT. (B)(4) PATIENT STATUS: "NO PATIENT INJURY".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5763292 ↗