Kii Dissecting Balloon C0H11Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00607915136703), received between Sep 12, 2019 and Feb 22, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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.

• InjuryFeb 22, 2023Positioning Failure; Positioning Failure

  PROCEDURE PERFORMED: LAPAROSCOPIC INGUINAL HERNIA REPAIR EVENT DESCRIPTION: THE REP WAS NOT PRESENT FOR THE CASE. DURING THE CASE THE SURGEON CLAIMED THE DEVICE WAS NOT DISSECTING PROPERLY AS IT WAS NOT SEPARATING THE TISSUE INTENDED FOR SEPARATION. THE BALLOON WAS INFLATING UNEVENLY, THERE WERE NO KNOWN PREVIOUS SURGERIES FOR THE PATIENT, AND THERE WERE NO REVEALED ANATOMICAL ISSUES THAT INTERFERED WITH THE INFLATION OF THE BALLOON. THE EVENT UNIT IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED BUT THE REMAINDER OF THE LOT WILL BE RETURNING. INTERVENTION: CONTINUED TO MANUALLY DISSECT WITH INSTRUMENTS. PATIENT STATUS: FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16422451 ↗
• InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE PERFORMED: RIGHT LAPAROSCOPIC INGUINAL HERNIA REPAIR WITH TEP APPROACH. EVENT DESCRIPTION: REP WAS PRESENT FOR THE CASE. UPON INITIAL INSERTION INTO THE PRE-PERITONEAL SPACE THE SURGEON HEARD A LOUD POPPING NOISE AFTER INSERTING THE DISSECTING BALLOON. THE SURGEON REINSERTED THE BALLOON AND INFLATED ABOUT 40 TIMES THEN WAITED APPROXIMATELY 15 SECOND, LET THE AIR OUT OF THE BALLOON, REMOVED THE DEVICE AND INSERTED A C0R47 TROCAR WITH A SCOPE. THE SURGEON IDENTIFIED A TEAR IN THE RIGHT SIDE OF THE PERITONEUM ABOUT THE SIZE OF THE TIP OF THE DISSECTING BALLOON INTRODUCER. THE PATIENT IS OK AND THE CASE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. PRODUCT IS AVAILABLE FOR RETURN. INTERVENTION: THE CASE WAS COMPLETED WITH THE SAME DEVICE. PATIENT STATUS: TEAR IN THE PATIENT'S PERITONEUM. PATIENT IS OK.

  Patient problems: Peritoneal Laceration(s)

  MAUDE report 15189012 ↗
• InjuryMay 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE PERFORMED: LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR. EVENT DESCRIPTION: APPLIED TEAM WAS NOT PRESENT DURING THE CASE. THE SURGEON IDENTIFIED THE CORRECT APPROACH PLANE UNDER DIRECT VISUALIZATION, INSERTED BALLOON, AND PUMPED 30 TIMES. SURGEON REPORTS USING USUAL TECHNIQUE AND DID NOT EXPECT ANY COMPLICATED PATIENT ANATOMY. AFTER REMOVING THE BALLOON, PLACING TROCAR, AND INSUFFLATING, HALF DOLLAR SIZED TEARS WERE FOUND ON THE FAR EDGES OF THE PERITONEUM BILATERALLY. THE CASE WAS COMPLETED SUCCESSFULLY USING THE TEP APPROACH WITH THE SAME DEVICE. NO PATIENT INJURY. PRODUCT IS AVAILABLE FOR RETURN. TYPE OF INTERVENTION: THE CASE WAS COMPLETED SUCCESSFULLY USING THE TEP APPROACH WITH THE SAME DEVICE. PATIENT STATUS: HALF DOLLAR SIZED TEARS WERE FOUND ON THE FAR EDGES OF THE PERITONEUM BILATERALLY, NO PATIENT INJURY.

  Patient problems: Peritoneal Laceration(s)

  MAUDE report 14528024 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE PERFORMED: LAPAROSCOPIC INGUINAL HERNIA REPAIR. EVENT DESCRIPTION: REP WAS NOT PRESENT FOR THE CASE. WHEN THE SURGEON STARTED TO INFLATE THE BALLOON HE SQUEEZED APPROXIMATELY 3-4 TIMES AND THEN HEARD A LOUD POPPING SOUND, THE SURGEON CONTINUED TO TRY TO INFLATE THE BALLOON AND WHEN IT WOULD NOT INFLATE THEY REMOVED IT FROM THE PATIENT. WHEN THE DISSECTING BALLOON WAS REMOVED, THEY NOTICED A HOLE IN THE BALLOON. THE SURGEON DID TRY TO REPOSITION THE BALLOON BEFORE REMOVING IT FROM THE PATIENT. UPON INSPECTION OF THE PATIENT THEY NOTICED FLUID IN THE ABDOMEN WHICH THEY DETERMINED CAME FROM THE PATIENT'S BLADDER WHERE THEY FOUND A TEAR. THE BLADDER TEAR WAS REPAIRED WITHOUT ISSUE AND A NEW DISSECTING BALLOON WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THE SURGEON DOES NOT KNOW WHETHER THE BALLOON CAUSED THE TEAR OR IF IT WAS CAUSED WHEN CREATING THE INCISION, THE PATIENT IS A YOUNG MALE AND MAY NOT HAVE EMPTIED HIS BLADDER BEFORE THE PROCEDURE CAUSING A SMALL WORKING SPACE FOR THE SURGEON TO INSERT THE BALLOON. IT IS UNKNOWN IF THE PATIENT HAD ANY PREVIOUS SURGERIES. PER THE REP THERE WAS NO BALLOON PARTICULATION. PRODUCT AVAILABLE FOR RETURN. INTERVENTION: TEAR WAS RE

  Patient problems: Laceration(s)

  MAUDE report 13653494 ↗
• InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE PERFORMED: LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR. EVENT DESCRIPTION: THE REP WAS PRESENT DURING THE CASE. AT THE START OF THE CASE, THE SURGEON DISSECTED DOWN TO THE DESIRED PLANE. THE SURGEON USED S RETRACTORS DURING THE DISSECTION. ONCE THE SURGEON REACHED THE PLANE, THE SURGEON PLACED THE BALLOON AT AN ANGLE THAT WAS ALMOST PARALLEL AGAINST THE PATIENT. THE SURGEON MADE 17 FULL PUMPS WITH THE BALLOON. THE SURGEON MADE SURE TO PROVIDE TIME BETWEEN EACH PUMP TO AVOID INFLATING THE BALLOON TOO RAPIDLY. THE SURGEON KEPT THE DEVICE IN POSITION DURING INFLATION AND DID NOT MOVE THE DEVICE. THE DEVICE WAS INFLATED UNDER DIRECT VISUALIZATION USING A SCOPE. AFTER THE 17 PUMPS THE SURGEON NOTED A TEAR IN THE LEFT SIDE OF THE POSTERIOR SHEATH OF THE PERITONEUM. THE SURGEON REMOVED THE BALLOON AND INSERTED AN APPLIED MEDICAL KID BALLOON BLUNT TIP TROCAR TO VISUALIZE THE PERITONEUM AND CONFIRM THE DEFECT. THE SURGEON THEN ELECTED TO ABORT THE TEP APPROACH AND INSERTED TROCARS THROUGH THE PERITONEUM AND INTO THE ABDOMINAL CAVITY TO PROCEED WITH THE CASE LAPAROSCOPICALLY. THE CASE WAS COMPLETED SUCCESSFULLY AND PATIENT STATUS IS FINE. PATIENT HAD A PRIOR BILATERAL INGUINAL HE

  Patient problems: Laceration(s)

  MAUDE report 13536114 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE PERFORMED: BILATERAL INGUINAL HERNIA REPAIR. EVENT DESCRIPTION: THE REP WAS PRESENT DURING THE CASE. AT THE START OF THE PROCEDURE, THE SURGEON MADE THE DISSECTION AND INSERTED THE DISSECTING BALLOON DEVICE INTO THE INCISION. THE SURGEON INSERTED THE 10MM SCOPE AND THEN ATTACHED THE BULB TUBING AND STARTED PUMPING THE BULB UNDER VISUALIZATION. AFTER ABOUT 10-11 PUMPS THE SURGEON NOTED THAT THE FASCIA ON THE LEFT SIDE OF THE PATIENT WAS DAMAGED AND HAD A HOLE. THE SURGEON BELIEVES THIS DAMAGE WAS CAUSED BY THE BALLOON. THE SURGEON DID NOT MOVE THE DEVICE DURING INFLATION. THE EXACT SIZE OF THE HOLE WAS NOT SPECIFIED TO THE REP. AFTER THE HOLE WAS NOTED, THE SURGEON CONTINUED FORWARD WITH THE TEP APPROACH. THE SURGEON HAD TO INSERT AN ADDITIONAL TROCAR INTO THE PATIENT DUE TO INSUFFLATION LEAKAGE THAT THE SURGEON ATTRIBUTED TO THE HOLE IN THE FASCIA. THE SURGEON USED AN ENERGY DEVICE TO CLOSE THE DEFECT IN THE FASCIA. THE PROCEDURE WAS COMPLETED AND PATIENT STATUS IS FINE. THE PATIENT HAS NO PRIOR SURGERIES, NO ANTICIPATED COMPLICATIONS, AND NO COMORBIDITIES. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 17JAN2022 FROM APPLIED MEDICAL REPRESE

  Patient problems: Perforation

  MAUDE report 13253242 ↗
• InjuryFeb 11, 2021Material Protrusion/Extrusion; Insufficient Device Problem Information; Material Protrusion/Extrusion; Insufficient Device Problem Information

  PROCEDURE PERFORMED: LAPAROSCOPIC INGUINAL HERNIA. EVENT DESCRIPTION: THE REP WAS INFORMED THAT THE PRODUCT SHEARED THE PERITONEUM ON THE SIDE AND RUINED THE EXPOSURE. THERE WAS A DELAY IN THE OR AND THE CASE WAS COMPLETED TRANSABDOMINALLY. IT IS UNKNOWN IF THERE WERE ANY ISSUES WITH THE BALLOON INFLATION. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 05FEB2021 FROM APPLIED MEDICAL REPRESENTATIVE: PATIENT IS FINE. TISSUE WAS TORN IN THE PREPERITINEAL SPACE AND CASE HAD TO BE DONE DIFFERENTLY THE SURGEON HAD A CLEAR VIEW THROUGH THE SCOPE. THE SURGEON DID NOT ATTEMPT TO MOVE THE BALLOON WHILE IT WAS INFLATED. THE BALLOON WAS NOT DEPLOYED IN THE WRONG DIRECTION. THE SEAL HOUSING WAS NOT REMOVED AT ANY POINT PRIOR TO THE PROCEDURE. NO PHOTOS OR VIDEOS ARE AVAILABLE OF THE COMPLAINT EVENT OR PRODUCT. INTERVENTION: TISSUE WAS TORN IN THE PREPERITINEAL SPACE AND CASE HAD TO BE DONE DIFFERENTLY, DELAY IN THE OR, CASE WAS COMPLETED TRANSABDOMINALLY. PATIENT STATUS: TISSUE WAS TORN IN THE PREPERITINEAL SPACE AND CASE HAD TO BE DONE DIFFERENTLY, PATIENT IS FINE.

  Patient problems: Excessive Tear Production; Peritoneal Laceration(s)

  MAUDE report 11317815 ↗
• InjurySep 12, 2019Use of Device Problem; Use of Device Problem

  PROCEDURE PERFORMED: TEP HERNIA. EVENT DESCRIPTION: THE INFLATION PUMP OF THE KII DISSECTING BALLOON DETACHED INVOLUNTARILY MULTIPLE TIMES (~6) DURING ATTEMPTED INFLATION, MEANING A REASONABLE AMOUNT OF AIR COULD NOT BE ADMINISTERED, AND EACH TIME THIS HAPPENED THE INFLATION WAS LOST. THERE IS NO FIXATION METHOD, NOR IS CLOSING THE STOPCOCK AN OPTION, AS IT WAS INVOLUNTARILY REMOVED SO THERE IS NO TIME TO CLOSE THE STOPCOCK. THE SURGEON ALSO ONLY HAS ONE HAND TO PERFORM THIS FUNCTION, WITH THE OTHER HOLDING THE TROCAR. THE KII DISSECTING BALLOON WAS ALSO INSERTED TOO FAR INTO THE PATIENT'S PRE-PERITONEAL SPACE. THE SURGEON COMPLAINED IT WAS NOT CLEAR TO IDENTIFY CORRECT PLACEMENT. THIS LED TO ASSOCIATED DAMAGE TO THE INTERNAL STRUCTURES, BLEEDING AND BRUISING, AS HE ADVANCED BEYOND THE PUBIC SYMPHYSIS. HE MENTIONED THE [COMPETITOR DEVICE] WAS MUCH EASIER TO PLACE CORRECTLY AND EASIER TO VISUALISE THE CORRECT PLACEMENT. THE SURGEON DID MENTION THE INJURY WAS POSSIBLY DUE TO HIS INEXPERIENCE WITH THE DEVICE, BUT THAT IT WAS DIFFICULT TO IDENTIFY CORRECT PLACEMENT. ADDITIONAL INFORMATION RECEIVED FROM REGIONAL FIELD IMPLEMENTATION TEAM MEMBER BY EMAIL ON 22AUG2019: AFTER THE BALLOON H

  Patient problems: Blood Loss; Bruise/Contusion

  MAUDE report 9008778 ↗