Kii Dissecting Balloon C0H12Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00607915137229), received between Aug 20, 2019 and Feb 25, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: TEP. EVENT DESCRIPTION: [TRANSLATION]BALLOON LOOSENS. BALLOON RELEASES. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 19FEB25: THE BALLOON CAME OFF THE TROCAR AFTER REMOVAL OF THE C0H12 AND GOT STUCK IN PATIENT AFTER DISSECTION WAS CREATED. HE REMOVED THE BALLOON WITH A GRASPER FROM THE PATIENT. THERE WHERE TWO SEPARATE INCIDENTS THAT DAY, THEY WERE NOT WITH THE SAME PATIENT. THE SECOND C0H12 WAS DISCARDED POST PROCEDURE. ACCORDING TO HIM BALLOON DISSECTION WENT WELL AND THE BALLOONS WERE INTACT BEFORE REMOVAL. NO BALLOON PARTICLES WERE FOUND IN BOTH PROCEDURES. PRODUCT WAS DISCARDED. INTERVENTION: REMOVED THE BALLOON WITH A GRASPER FROM THE PATIENT. PATIENT STATUS: PATIENT IS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21463365 ↗
• MalfunctionFeb 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: TEP. EVENT DESCRIPTION: BALLOON LOOSENS. [TRANSLATED] BALLOON RELEASES. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 19FEB2025: THE SURGEON STATED TO THE TM. THE BALLOON CAME OFF THE TROCAR AFTER REMOVAL OF THE C0H12 AND GOT STUCK IN PATIENT AFTER DISSECTION WAS CREATED. HE REMOVED THE BALLOON WITH A GRASPER FROM THE PATIENT. THERE WHERE TWO SEPARATE INCIDENTS THAT DAY, THEY WERE NOT WITH THE SAME PATIENT. THE SECOND C0H12 WAS DISCARDED POST PROCEDURE. ACCORDING TO HIM BALLOON DISSECTION WENT WELL AND THE BALLOONS WERE INTACT BEFORE REMOVAL. NO BALLOON PARTICLES WERE FOUND IN BOTH PROCEDURES. INTERVENTION: REMOVED THE BALLOON WITH A GRASPER FROM THE PATIENT. PATIENT STATUS: PATIENT IS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462409 ↗
• MalfunctionApr 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP COL. EVENT DESCRIPTION: NORMAL USE DURING TEPP PROCEDURE, BALLOON CAME LOOSE FROM TROCAR WHEN PULLED OUT OF PATIENT. TYPE OF INTERVENTION: PULLED OUT THE BALLOON MANUALLY. PATIENT STATUS: NO HARM DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19038656 ↗
• MalfunctionNov 3, 2021Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: HERNIE RETROPERITONEALE / RETRO-PERITONEAL HERNIA. EVENT DESCRIPTION: "THE BALLOON EXPLOSED INTO THE RETROPERITONEAL CAVITY. A PIECE ON PLASTIC COULDN'T BE PICK UP AND EXPOSE THE PATIENT TO SSI" THE PRODUCT WAS SEND TO DECONTAMINATION AND AVAILABLE TO BE PICK UP AT THE PHARMACY. FROM CUSTOMER COMPLAINT FORM [TRANSLATION]: DURING THE PREPARATION OF THE PREPERITONEAL SPACE THE BALLOON BURST LEAVING A PIECE OF PLASTIC INSIDE THE PATIENT. REMOVAL OF THE PIECE OF PLASTIC FROM THE PATIENT'S BODY. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 29OCT21: THE BALLOON HAS BLOWN UP INTO THE RETROPERITONEAL CAVITY OF THE PATIENT AS EXPLAIN IN THE FORM ATTACHED. SO THE SURGEON HAD TO PICK UP EVERY PIECES OF THE BALLOON INTO THE CAVITY BEFORE TO CONTINUE THE CASE. THE RISK OF INFECTIONS WAS HIGH BUT FORTUNATELY DIDN¿T AFFECT THIS PATIENT. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 25NOV21: THE SCOPE BRAND IS A [DEVICE NAME] OF 10MM AND 0°. INTERVENTION: RETRIEVAL OF SEPARATED PART. PATIENT STATUS: THE RISK OF INFECTIONS WAS HIGH BUT FORTUNATELY DIDN¿T AFFECT THIS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745950 ↗
• MalfunctionOct 27, 2021Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: TEPP. EVENT DESCRIPTION: DURING INFLATION, THE BALLOON BURST AGAIN AND EVEN A PART OF IT LAY IN THE EXTRAPERITONEAL SPACE. THE BELLOWS WERE OPERATED FOR ABOUT 10-15 TIMES. THE PATIENT WAS NOT HARMED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 29-NOV-2021: CUSTOMER ALWAYS USES A 0 DEGREE SCOPE FOR INGUINAL HERNIA REPAIRS. MANUFACTURER [ ], 10MM DIAMETER. REPRESENTATIVE HAS TESTED THIS AND INFLATED THE BALLOON 40 TIMES AND HAS TRIED TO DAMAGE THE BALLOON WITH THE SCOPE SEVERAL TIMES. THIS DID NOT WORK. HE ALSO VERIFIED IF THE SCOPE BECAME HOT, THIS WAS NOT THE CASE EITHER. INTERVENTION: RETRIEVAL OF SEPARATED PART. PATIENT STATUS: THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12708418 ↗
• InjurySep 2, 2021Burst Container or Vessel; Burst Container or Vessel

  PROCEDURE PERFORMED: TEP HERNIA/ EVENT DESCRIPTION: DURING THE PROCEDURE, THE DILATATION TROCAR IN THE ABDOMEN BURST! THE PATIENT SUFFERED A MAJOR HEMORRHAGE. THE PATIENT IS DOING WELL AND THE BLEEDING WAS STOPPED BY CLIPS. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON (B)(6) 2021: THE VOLUME OF BLOOD LOST IS ESTIMATED AT ABOUT 50 ML. THERE IS NO INFORMATION AVAILABLE ABOUT THE SOURCE OF THE BLEEDING. ADDITIONAL INFORMATION FROM BFARM USER REPORT RECEIVED VIA EMAIL (B)(6) 2021: [TRANSLATION] THE DISSECTION BALLOON BURST DURING REGULAR USE AS PART OF TEP HERNIA SURGERY. THE BALLOON WAS COMPLETELY REMOVED. THE INCIDENT WAS REPORTED TO APPLIED MEDICAL'S REPRESENTATIVE. APPLIED MEDICAL HAS ALREADY MADE A REPORT TO THE BFARM. ALL DISSECTION BALLOONS WITH THE ABOVE LOT NUMBER HAVE BEEN RETURNED TO THE COMPANY. NO MORE PROBLEMS HAVE OCCURRED WITH THE REPLACEMENT PRODUCTS. INTERVENTION: CLIP PLACEMENT. PATIENT STATUS: PAT. OK.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12418427 ↗
• MalfunctionFeb 3, 2021Gas/Air Leak; Gas/Air Leak

  PROCEDURE PERFORMED: TEP HERNIA. EVENT DESCRIPTION: THE DISSECTING BALLON RUPTURED AFTER SOME PUMPS. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11276736 ↗
• MalfunctionAug 20, 2019Positioning Problem; Positioning Problem

  PROCEDURE PERFORMED: RIGHT LAP TEP INGUINAL HERNIA. EVENT DESCRIPTION: FEEDBACK FORM: TROCAR SET UP: KBBT IN UMBILICUS, 2 EA. 5X100MM ADV FIX DOWN MIDLINE [LUBE] APPLIED TO SHEATH BEFORE INSERTION. DR. [NAME] INSERTS THE BALLOON DIAGONALLY TOWARD THE DEFECT, NOT DOWN THE MIDLINE. ABLE TO INTRODUCE THE INTO THE WORKING SPACE UPON FIRST ENTRY IN AN ATRAUMATIC FASHION. [] 10MM ENDOSCOPE WAS USED. 20 PUMPS USED TO INFLATE BALLOON AND SCOPE WAS NOT USED DURING INFLATION. "TOO MUCH DISSECTION TOWARD EPIGASTRIC. FEELS OUR BALLOON INFLATED MORE LATERALLY VS. NORTH TO SOUTH." SURGEON DID DEPLOY THE DEVICE WITH STOPCOCK FACING UP. BALLOON DID NOT SERVE AS TAMPONADE. SURGEON INFLATED 20 PUMPS AND "WAITED FOR ABOUT 20 SECONDS, BUT THERE WAS ALOT OF BLEEDING. HE SAID THAT WAS DUE TO THE BALLOON DAMAGING THE EPIGASTRIC". CASE LENGTH WAS 34 MINUTES AND DEFLATING/REMOVING DEVICE PROCESS WAS ACCEPTABLE. DR. [NAME] SAID THAT WITH HIS TECHNIQUE OF INSERTING THE BALLOON DIAGONALLY, NOT DOWN THE MIDLINE OUR BALLOON DAMAGED THE EPIGASTRIC AND CAUSES BLEEDING. HE SAID MAJORITY OF SURGEONS PROBABLY GO MORE DOWN THE MIDLINE BUT NOT HIM. ADDITIONAL INFORMATION WAS RECEIVED VIA TELEPHONE ON 16AUG2019 AT 7:58

  Patient problems: Blood Loss

  MAUDE report 8911249 ↗