Kii Balloon Blunt Tip SystemRecalls & reported problems across all models

We found 3 models of Kii Balloon Blunt Tip System by Applied Medical Resources Corporation in the FDA's device registry (GUDID). Together they are named in 263 adverse event reports in the FDA's MAUDE database, received between Jan 25, 2016 and Jun 17, 2026 — classified as 3 injuries, 259 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (100 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 Balloon Blunt Tip System problems

Kii Balloon Blunt Tip System models

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

• Kii® Balloon Blunt Tip System C0R47

  Laparoscope, General & Plastic Surgery
  224 reports
• Kii® Balloon Blunt Tip System C0R50

  Laparoscope, General & Plastic Surgery
  38 reports
• Kii® Balloon Blunt Tip System C0Q20

  Laparoscope, General & Plastic Surgery
  1 report

Recent Kii Balloon Blunt Tip System adverse event reports

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

• MalfunctionJun 17, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP ANTERIOR RESECTION. EVENT DESCRIPTION: MID WAY THROUGH THE CASE, SURGEON USES AN ARTERY TO GRAB A GAUZE TO CLEAN THE INNER PORT. CAMERA WAS INSERTED SUBSEQUENTLY. THESE STEPS WERE REPEATED SEVERAL TIMES BEFORE THE RUBBER SEAL CAME OFF. NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 04-JUN-2026: NO PIECES FELL INTO THE PATIENT. NO INTERNAL SEAL COMPONENTS WERE REMOVED OR CUT TO INSPECT THE DAMAGED COMPONENT. INTERVENTION: A NEW TROCAR WAS OPENED. PATIENT STATUS: NOTHING; NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534477 ↗
• MalfunctionFeb 12, 2026Material Fragmentation

  PROCEDURE PERFORMED: NI EVENT DESCRIPTION: INFORMATION RECEIVED VIA CUSTOMER COMPLAINT FORM, ON (B)(6) 2026: [TRANSLATION]THE TIP OF A LAPAROSCOPIC TROCAR BROKE OFF INSIDE THE PATIENT'S ABDOMEN AND WAS NOT RECOVERED. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 22JAN26 & 27JAN26: WAITING FOR MORE INFORMATION. RETURN POSSIBLE BUT WAITING FOR DETAILS. HOSPITAL DOESN'T WANT REPLACEMENT NOR CREDIT. NCA COMPLAINT EMAIL RECEIVED 23JAN26: REGULATORY HEALTH AUTHORITY REFERENCE NUMBER (B)(4). INTERVENTION: LAPAROTOMY PERFORMED TO TRY AND LOCATE THE TIP, BUT WITHOUT SUCCESS. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328383 ↗
• MalfunctionJan 9, 2026Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA (BEFORE USE) DETAILED DESCRIPTION OF EVENT THIS IS A COMPLAINT FROM THE HOSPITAL; SOMETHING LIKE HAIR WAS CONTAMINATED. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED WITH A HOSPITAL INVENTORY, AND THE PROCEDURE WAS COMPLETED. THE INVESTIGATION REPORT HAS BEEN NOT REQUESTED BY THE HOSPITAL. THIS EVENT UNIT WILL BE RETURNED. TYPE OF INTERVENTION: REPLACED WITH A HOSPITAL INVENTORY AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NA (BEFORE USE)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24030119 ↗
• MalfunctionDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC CYSTECTOMY. EVENT DESCRIPTION: "[TRANSLATION]" TROCART ABDO ENDOCHIR BLUNT TIP BALT D.5-12MM L.100MM OPEN COELIO, REFERENCE C0R47, BATCH 1560795 THIS INCIDENT WAS REPORTED ON (B)(6) 2025 BY THE GYNECOLOGY OPERATING ROOM DEPARTMENT AT "[HOSPITAL NAME]". DESCRIPTION OF THE INCIDENT: LOSS OF THE TROCAR REDUCER (WHICH FELL INTO THE INTRAPERITONEAL CAVITY) DURING A LAPAROSCOPIC CYSTECTOMY. IT WAS REMOVED AND THE PROCEDURE CONTINUED. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 17DEC2025: NO ADDITIONAL INFO (EVENT DATE CONFIRMED). INTERVENTION: IT WAS REMOVED AND THE PROCEDURE CONTINUED. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866664 ↗
• InjuryNov 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: WHILE TROCAR WAS IN PATIENT, THERE WAS A STRUGGLE TO REMOVE AN INSTRUMENT FROM THE TROCAR. MULTIPLE ATTEMPTS WERE MADE WITH PULLING AND TUGGING TO REMOVE THE INSTRUMENT. WHEN TROCAR WAS REMOVED FROM PATIENT, TWO BLACK RUBBER PIECES WERE PULLED OUT OF THE TROCAR RENDERING THE TROCAR BROKEN. UNKNOWN TO THE SURGICAL TEAM AT THAT TIME, A SMALLER CLEAR RUBBER PIECE WAS RETAINED IN THE PATIENT. AFTER EXPERIENCING COMPLICATIONS WITH RECOVERY, PATIENT RETURNED, A CAT SCAN WAS PERFORMED, AND IMAGING IDENTIFIED A RETAINED FOREIGN OBJECT. ADDITIONAL SURGERY WAS PERFORMED TO REMOVE THE OBJECT. INTERVENTION: A CAT SCAN WAS PERFORMED, AND IMAGING IDENTIFIED A RETAINED FOREIGN OBJECT. ADDITIONAL SURGERY WAS PERFORMED TO REMOVE THE OBJECT. PATIENT STATUS: AFTER EXPERIENCING COMPLICATIONS WITH RECOVERY, PATIENT RETURNED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23645805 ↗
• MalfunctionNov 17, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC ESOPHAGECTOMY. EVENT DESCRIPTION: DURING THE PATIENT¿S CHEST TIME, AFTER POSITIONING THE HASSON TROCAR, THE TIP (BELOW THE BALLOON) ACCIDENTALLY BROKE INTO TWO PIECES. THESE FELL INSIDE THE PATIENT¿S CHEST AND WERE PROMPTLY IDENTIFIED BY ALL MEMBERS OF THE TEAM AND REMOVED WITHOUT CAUSING ANY CONSEQUENCES THAT COULD AFFECT THE PATIENT¿S SAFETY. SUBSEQUENTLY, THE SCRUB NURSES, TOGETHER WITH THE SURGEONS AND THE REST OF THE TEAM, CHECKED THAT THE PIECES MATCHED TO VERIFY THAT THEY HAD BEEN REMOVED COMPLETELY. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 07NOV25: CANNULA BROKEN. IDENTIFICATION OF THE BREAK: INTERVENTION OF ESOPHAGECTOMY. IT WAS THE SECOND TIME OF THE INTERVENTION (THORACIC TIME) WHEN A TROCAR (IN THIS CASE C0R47) IS BEING INSERTED BETWEEN TWO RIBS. THE PATIENT WAS WITH RIBS VERY CLOSED TO EACH OTHER AND WITH LITTLE SPACE BETWEEN ONE RIB AND THE OTHER. DR (B)(6) INSERTED THE HASSON TROCAR THROUGH A MINI OPEN INCISION AS USUAL WITH NO ROTATION OF THE TROCAR (BUT WITH DIFFICULTY DUE TO THE STRICT RIBS) AND PUT INSIDE THE TROCAR THE VIDEO CAMERA WHEN HE SAW THREE FRAGMENTS OF THE TROCAR LAYING ON THE LU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570772 ↗
• MalfunctionOct 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: DIAGNOSTIC LAP. EVENT DESCRIPTION: I FOUND OUT YESTERDAY THAT MY ACCOUNT (B)(4) [FACILITY NAME], HAD AN ISSUE WITH ONE OF 12X100 TROCARS ¿CTF73¿. I WAS TOLD A PT. CAME BACK IN TO THE HOSPITAL ON (B)(6) 2025 WITH A HEMATOMA AFTER A DIAGNOSTIC LAP THAT WAS DONE WEEK AND HALF AGO. I¿M NOT SURE IF THE BROKEN PIECE WAS IN THE INCISION OR FOUND IN THE ABDOMEN. THE PIECE WAS THE SMALL CLEAR SEAL PART THAT IS ABOUT THE SIZE OF A DIME. THE OR MANAGER TOOK APART A DIFFERENT 12X100 TROCAR TO MATCH THE PIECE FOUND IN THE PATIENT. I HAVE ATTACHED THE PHOTO SHE SENT ME TO GIVE YOU AN IDEA OF WHAT THE PART LOOKS LIKE. I WAS TOLD BY THE OR MANAGER [NAME] THAT THE PIECE HAS TO BE SENT TO TWO DIFFERENT PLACES IN [FACILITY] BEFORE THEY CAN SHIP THE PIECE TO APPLIED MEDICAL CORPORATE. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 21OCT2025: I FOUND OUT THAT THE TROCAR IN QUESTION WAS A 12MM HASSON TROCAR. WHEN I LOOKED AT THEIR STOCK OF C0R47 THESE ARE THE TWO LOT NUMBERS THAT CAME UP. LOT 1562053. LOT 1556663. THIS IS ALL THE INFORMATION THEY HAVE GIVEN ME AT THIS TIME. PATIENT STATUS: PT. CAME BACK IN TO THE HOSPITAL ON (B)(6) 2025 WITH A HEMATOMA AFTER A

  Patient problems: Hematoma

  MAUDE report 23405462 ↗
• MalfunctionSep 10, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF THE PROCEDURE BEING PERFORMED: NA (BEFORE USE). DETAILED DESCRIPTION OF EVENT: THIS IS A COMPLAINT FROM THE HOSPITAL. FOREIGN OBJECT (HAIR) DETECTED BEFORE OPENING THE STERILE POUCH. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED TO A NEW HOSPITAL INVENTORY C0R47 AND PROCEDURE WAS COMPLETED. THIS EVENT UNIT WILL BE RETURNED. TYPE OF INTERVENTION: REPLACED TO A HOSPITAL INVENTORY NEW C0R47 AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NA (BEFORE USE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017676 ↗
• MalfunctionAug 28, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA (BEFORE USE). DETAILED DESCRIPTION OF EVENT: HOSPITAL NAME: [NAME] HOSP. THIS IS A COMPLAINT FROM THE HOSPITAL. FOREIGN MATERIAL SUCH AS HAIR WAS FOUND IN THE SYRINGE. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED TO A NEW HOSPITAL INVENTORY C0R47 AND PROCEDURE WAS COMPLETED. THE INVESTIGATION REPORT HAS BEEN REQUESTED BY THE HOSPITAL. THIS EVENT UNIT WILL BE RETURNED. TYPE OF INTERVENTION: REPLACED TO A HOSPITAL INVENTORY AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22917088 ↗
• MalfunctionAug 26, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: DIGESTIVE SURGERY. EVENT DESCRIPTION: [TRANSLATION] USE OF THE LAPAROSCOPIC TROCAR INTO WHICH THE 8 MM ROBOTIC TROCAR IS INSERTED (STANDARD TECHNIQUE RECOMMENDED BY INTUITIVE WHEN USING THE ROBOT WITH AN OPEN LAPAROSCOPY TECHNIQUE). SURGERY PERFORMED WITHOUT ANY PARTICULAR DIFFICULTIES. AT THE END OF THE PROCEDURE, WHEN THE TROCARS WERE REMOVED, IT WAS FOUND THAT THE DISTAL END OF THE LAPAROSCOPIC TROCAR WAS BROKEN WITH A PIECE MISSING. THE MISSING PART WAS SEARCHED FOR SEVERAL HOURS USING LAPAROSCOPY AND THEN LAPAROTOMY: ONLY ONE MISSING PART WAS FOUND AND REMOVED. CLINICAL CONSEQUENCES: LONGER PROCEDURE DUE TO THE SEARCH FOR THE MISSING PART OF THE DISTAL END OF THE TROCAR AND THE ASSOCIATED RISKS. IF THE MISSING PART IS STILL IN THE ABDOMEN, IT CAN CAUSE VASCULAR EROSION OR ORGAN EROSION WITH SERIOUS CONSEQUENCES OR EVEN A RISK TO THE PATIENT'S LIFE. CONSEQUENCES FOR THE PATIENT/CAREGIVER: THE IMMEDIATE SITUATION IS ANXIETY PROVOKING AND HIGHLY DESTABILIZING FOR THE PATIENT AND THEIR FAMILY AS WELL AS FOR MEDICAL AND NON-MEDICAL STAFF. SEARCH FOR THE MISSING PART FOR SEVERAL HOURS USING LAPAROSCOPY FOLLOWED BY A LAPAROTOMY. A CT SCAN WAS PERFORMED TO LOCATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897637 ↗
• MalfunctionJul 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC HEPATECTOMY EVENT DESCRIPTION: THIS IS A COMPLAINT FROM THE HOSPITAL; IT IS DIFFICULT TO REMOVE THE OBTURATOR AND THE SEAL PART FELL APART. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED TO A NEW HOSPITAL INVENTORY C0R47 AND PROCEDURE WAS COMPLETED. THIS EVENT UNIT WILL BE RETURNED. INTERVENTION: REPLACED TO A HOSPITAL INVENTORY NEW C0R47 AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609443 ↗
• MalfunctionJul 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  MEDSUN (B)(4). PROCEDURE PERFORMED: ROBOTIC XI ASSISTED LAPAROSCOPIC PROSTATECTOMY. EVENT DESCRIPTION: INITIAL BALLOON WAS DEFECTIVE REQUIRING OR TEAM MEMBER TO OBTAIN A NEW ONE AND THIS ONE WORKED FINE. NO ADVERSE PROBLEMS FOR THE PATIENT RESULTED WITH THE DEFECTIVE BALLOON. THE SALES REPRESENTATIVE WAS CONTACTED REGARDING THIS EVENT. DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. NO EXACT EVENT DATE IS GIVEN, BUT THE EVENT OCCURRED IN JUN2025. ADDITIONAL INFORMATION RECEIVED FROM HOSPITAL REPRESENTATIVE VIA EMAIL ON 30JUN2025: THE BALLOON MALFUNCTIONED DURING INSERTION/ THERE WAS DAMAGE TO THE BALLOON. THE HOSPITAL DOES NOT KNOW IF THERE WAS A LEAK OR BROKEN BALLOON. NO SHARMP INSTRUMENTS CAME INTO CONTACT WITH THE BALLOON. ADDITIONAL INFORMATION RECEIVED FROM ACCOUNT MANAGER VIA EMAIL ON 30JUN2025: THE EVENT DATE WAS 11JUN2025. INTERVENTION: OR TEAM MEMBER TO OBTAIN A NEW ONE AND THIS ONE WORKED FINE. PATIENT STATUS: NO ADVERSE PROBLEMS FOR THE PATIENT RESULTED WITH THE DEFECTIVE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22388570 ↗
• MalfunctionJun 19, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: A PART SEEMED TO BE PART OF C0R47 DROPPED OFF IN THE ABDOMINAL CAVITY. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED TO A NEW HOSPITAL INVENTORY C0R47 AND PROCEDURE WAS COMPLETED. THE INVESTIGATION REPORT HAS BEEN REQUESTED BY THE HOSPITAL. THIS EVENT UNIT WILL BE RETURNED. ADDITIONAL INFORMATION RECEIVED ON 06 JUN 2025 VIA EMAIL FROM APPLIED MEDICAL SALES REPRESENTATIVE: IT LOOKED LIKE A PART OF C0R47 AND IT WAS BLACK, IN ADDITION, IT WAS LIKELY A C0R47 PART RATHER THAN A FRAGMENT. INTERVENTION: REPLACED TO A HOSPITAL INVENTORY NEW C0R47 AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293251 ↗
• MalfunctionJun 9, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  PROCEDURE PERFORMED: NA. EVENT DESCRIPTION: NURSE WAS CHECKING HER SUPPLIES PRIOR TO THE CASE, FOUND THE TROCAR WITH REMOVABLE TURQUOISE RING SHOVED OVER BALLOON DOWN TROCAR, CONCERN WITH INTEGRITY OF BALLOON. REMOVED. GRABBED AND OPENED A NEW TROCAR. ADDITIONAL INFORMATION PROVIDED VIA PHONE ON (B)(6) 2025 AT 11:30AM TO APPLIED MEDICAL REPRESENTATIVE BY CUSTOMER: EVENT DATE IS 27APR2025. PRODUCT IS AVAILABLE FOR RETURN. CUSTOMER REQUESTING CREDIT SINCE LOT NUMBER IS PROVIDED. RETURN IS AVAILABLE. MEDWATCH REPORT (B)(4) RECEIVED VIA EMAIL ON 02JUN2025. INTERVENTION: GRABBED AND OPENED A NEW TROCAR. PATIENT STATUS: NA, EVENT OCCURRED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169230 ↗
• MalfunctionMar 19, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  NAME OF PROCEDURE BEING PERFORMED: NA (BEFORE USE). DETAILED DESCRIPTION OF EVENT: UPON RECEIVING THE GOODS, THE CUSTOMER NOTICED DAMAGE ON THE PRINTED SIDE OF THE STERILIZATION POUCH AND THEREFORE RETURNED IT TO US. PLEASE FIND THE ATTACHED PHOTOS FOR YOUR REFERENCE. THE CUSTOMER DID NOT USE THE PRODUCT DURING SURGERY AND DIRECTLY REQUESTED US TO RETRIEVE IT. WE HAVE REPLACED IT WITH A NEW UNIT FOR THE CUSTOMER. TYPE OF INTERVENTION: THE CUSTOMER DID NOT USE THE PRODUCT DURING SURGERY AND DIRECTLY REQUESTED US TO RETRIEVE IT. WE HAVE REPLACED IT WITH A NEW UNIT FOR THE CUSTOMER. PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643782 ↗

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