Kii Shielded Bladed Access System CTB33Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00607915124250), received between Jun 7, 2016 and Mar 20, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: CHOLECYSTECTOMY. EVENT DESCRIPTION: DURING THE PROCEDURE, IT WAS OBSERVED THAT THE TROCAR WAS LEAKING. IT WAS NECESSARY TO REPLACE THE MATERIAL WITH ANOTHER. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 12NOV2024: THE PATIENT'S STATUS IS STABLE. THE EVENT WAS COMPLETED AFTER REPLACING THE TROCAR WITH ANOTHER. THE PROCEDURE BEING PERFORMED WAS A CHOLECYSTECTOMY. A VERESS NEEDLE AND AN [BRAND NAME] CLIP WERE USED WITH THE TROCAR. THE LEAK WAS NOTICED AT THE BEGINNING OF THE PROCEDURE. IS IT UNKNOWN WHAT INSTRUMENTATION PASSED THROUGH THE EVENT UNIT(S) DURING THE PROCEDURE. THERE WAS NO COMPONENT DAMAGE. INTERVENTION: IT WAS NECESSARY TO REPLACE THE MATERIAL WITH ANOTHER. PATIENT STATUS: STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21658670 ↗
• InjuryAug 8, 2023Retraction Problem; Retraction Problem

  PROCEDURE PERFORMED: COELIOSCOPIE / LAPAROSCOPY. EVENT DESCRIPTION: [TRANSLATION] WHEN THE FIRST SINGLE-USE RETRACTABLE-BLADE TROCAR WAS INSERTED, THE BLADE APPEARED TO HAVE COME OUT OF THE TROCAR SHEATH ON ENTERING THE PERITONEUM, RESULTING IN A WOUND ON THE SMALL INTESTINE AT THE CAMERA ENTRANCE. PATIENT'S PRESENT CONDITION: IMMEDIATE LAPAROTOMY FOR DIGESTIVE SUTURE AND ABDOMINAL LAVAGE. ANTIBIOTIC PROPHYLAXIS IN PRINCIPLE. ACTIONS TAKEN IN THE CARE FACILITY TO MANAGE THE PATIENT: TROCAR WASHED. EQUIPMENT KEPT IF REQUESTED BY LAB. INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL (B)(6) 2023: THE PATIENT¿S STATUS OF HEALTH IS GOOD. HE STAYED LONGER AT THE HOSPITAL THAN PLANNED BUT NOW IT IS OK. INTERVENTION: IMMEDIATE LAPAROTOMY FOR DIGESTIVE SUTURE AND ABDOMINAL LAVAGE. ANTIBIOTIC PROPHYLAXIS IN PRINCIPLE. PATIENT STATUS: THE PATIENT¿S STATUS OF HEALTH IS GOOD. HE STAYED LONGER AT THE HOSPITAL THAN PLANNED BUT NOW IT IS OK.

  Patient problems: Laceration(s)

  MAUDE report 17484600 ↗
• MalfunctionApr 7, 2023Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAP CHOLE. EVENT DESCRIPTION: "THE FACILITY REPORTED A PIECE OF PLASTIC STUCK WITHIN THE CANULA RENDERING THE DEVICE UNUSABLE..." PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 05APR2023 VIA EMAIL FROM APPLIED MEDICAL REPRESENTATIVE: NO INJURY OCCURRED. ANOTHER CTB33 WAS USED TO COMPLETE THE CASE. THE COLOR OF THE PIECE WAS BLUE. NO PIECES FELL INTO THE PATIENT. LAPAROSCOPIC TOWER WAS BEING USED AT THE TIME OF THE INCIDENT. NO OTHER INSTRUMENTS WERE USED PRIOR TO THE INCIDENT. INTERVENTION: ANOTHER CTB33 WAS USED TO COMPLETE THE CASE. PATIENT STATUS: NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704189 ↗
• MalfunctionMar 30, 2022Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: TAMIS: TRANSANAL MINIMAL INVASIVE PROCEDURE FOR REMOVAL OF A RECTAL POLYP. EVENT DESCRIPTION: SURGEON WAS PERFORMING A DIFFICULT LAP CHOLE CASE, THERE APPEARED TO BE NO VISIBLE DEFECT IN THE TROCAR FROM WHEN IT WAS OPENED FROM ITS PACKAGING. ALSO THE TROCAR PERFORMED AS NORMAL UPON INSERTION INTO THE ABDOMEN. THE RESECTION OF THE GALLBLADDER WAS COMPLETED BUT SOME GALL STONES DID FALL INTO THE ABDOMEN. AS THE SURGEON WAS RETRIEVING THESE STONES THE SCRUB NURSE NOTICED AT THAT POINT A FRAGMENT OF PLASTIC IN THE ABDOMEN, UPON INSPECTION IT WAS IDENTIFIED AS A FRAGMENT OF THE 11X100MM TROCAR. THERE WERE A FEW SMALL PIECES INSIDE THE ABDOMEN THAT REQUIRED RETRIEVAL. ONCE THE FRAGMENTS WERE RETRIEVED THEY WERE MATCHED UP OUTSIDE THE PATIENTS ABDOMEN TO CONFIRM ALL PIECES WERE COLLECTED. THE SURGEON & SCRUB NURSE HAS NEVER SEEN THIS HAPPEN BEFORE AND BOTH HAVE OVER TWENTY YEARS EXPERIENCE. NO PATIENT WAS NOT AFFECTED AND THE CASE WAS COMPLETED. INTERVENTION: RETRIEVAL OF SEPARATED PARTS. PATIENT STATUS: RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13955936 ↗
• MalfunctionNov 11, 2021Break; Break

  PROCEDURE PERFORMED: HERNIA. EVENT DESCRIPTION: PER CUSTOMER EXPERIENCE REPORT: IN THE SURGERY, THE WING TAB WAS BROKEN SUDDENLY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 01NOV2021 FROM [DISTRIBUTOR]: THE BREAK WAS IDENTIFIED ABOUT AN HOUR LATER. THE TROCAR WAS INSERTED WITHOUT ANY ROTATION. THE BREAK WAS CONSIDERED NOT CLEAN AND PARTIALLY BROKEN. THE BREAK DID NOT CAUSE ANY PARTICULATION. THE TROCAR WAS NOT USED WITH A ROBOT. AT THE TIME OF THE INCIDENT, THE GRASPER WAS INSIDE OF THE CANNULA. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 02NOV2021 FROM [DISTRIBUTOR]: THE CASE WAS COMPLETED BY REPLACING THE TROCAR WITH A NEW ONE. INTERVENTION: THE CASE WAS COMPLETED BY REPLACING THE TROCAR WITH A NEW ONE. PATIENT STATUS: FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12796857 ↗
• MalfunctionApr 14, 2021Retraction Problem; Retraction Problem

  PROCEDURE PERFORMED: LAPAROSCOPIC STERILIZATION . EVENT DESCRIPTION: THE PRODUCT WAS OPENED BEFORE THE PROCEDURE STARTED AND UPON INSPECTION BY THE SURGEON BEFORE USAGE SHE SAW THAT THE BLADE DID NOT WANT TO RETRACT. IT WAS NOT USED DURING THE PROCEDURE AND WAS NOT IN CONTACT WITH ANY BODILY FLUIDS OR THE PATIENT. NO ONE WAS HURT DURING THE PROCEDURE. PATIENT STATUS: WAS NOT IN CONTACT WITH ANY BODILY FLUIDS OR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11667545 ↗
• MalfunctionFeb 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: "LAPAROSCOPIC LEFT SALPINGO-OOPHORECTOMY". EVENT DESCRIPTION: FROM MEDWATCH REPORT #(B)(4): "WHEN TRYING TO REMOVE THE SPECIMEN AT THE END OF THE PROCEDURE, THE KII SHIELDED BLADED 11X 100MM TROCAR BEGAN TO FALL APART WHILE INSIDE THE PATIENT. ADDITIONALLY, WHILE THE SPECIMEN WAS BEING REMOVED VIA A [SPECIMEN RETRIEVAL BAG], IT FELL APART INSIDE PATIENT. BOTH BROKEN ITEMS WERE SUCCESSFULLY REPLACED DURING THE PROCEDURE WITH NO ADDITIONAL ISSUES AND NO RETAINED ITEMS. THE PATIENT WAS DISCHARGED HOME PER SURGICAL PLAN." "DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)". ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 03FEB2021 FROM USER FACILITY: PER STAFF REPORT "THE WHITE TOP FELL OFF THE GREEN RIGID Z-THREADED SLEEVE OF THE OBTURATOR WHILE INSERTING THE [SPECIMEN RETRIEVAL BAG]. GAS BEGAN LEAKING, HAD TO REATTACH THE PIECES OF THE OBTURATOR". THIS PRODUCT WAS DISCARDED. STAFF HAVE BEEN REMINDED TO SAVE BROKEN DEVICES FOR MANUFACTURER FAILURE ANALYSIS. INTERVENTION: "BOTH BROKEN ITEMS WERE SUCCESSFULLY REPLACED DURING THE PROCEDURE WITH NO ADDITIONAL ISSUES AND NO RETAINED ITEMS." PATIENT STATUS: "THE PATIENT WAS DISCHARGED HOME PER SURGICAL

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

  MAUDE report 11283367 ↗
• MalfunctionNov 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: OVARIECTOMY. EVENT DESCRIPTION: PHONE CONVERSATION WITH THE SALES REP ON 27OCT20: AS DISCUSSED BY PHONE YOU HAVE BEEN AWARE OF AN INCIDENT WITH MODEL CTB33 WHERE A PIECE OF COMPONENT FROM THE SEAL FELL INSIDE THE PATIENT. COMMUNICATION RECEIVED BY EMAIL FROM ANSM ON 29OCT20: TRANSLATION: ON AN OPERATION PERFORMED UNDER LAPAROSCOPY BY DR [NAME], THE SMALL INTERNAL BLACK VALVE OF THE APPLIED TROCAR REF CTB33 LOT 1386896 WAS FOUND IN THE ABDOMINAL CAVITY. THE SURGEON NOTED THE PRESENCE OF THIS FOREIGN BODY DURING THE REMOVAL OF THE ANATOMICAL PIECE AND THE VALVE COULD BE REMOVED WITHOUT CONSEQUENCE FOR THE PATIENT. CURRENT STATE OF THE PATIENT: NO CONSEQUENCE ACTIONS TAKEN IN THE CARE ESTABLISHMENT TO TAKE CARE OF THE PATIENT: ACTIONS TAKEN FOR THE PATIENT WITH REGARD TO THE MEDICAL DEVICE PART WITHDRAWN NO ACTION TAKEN ACTIONS TAKEN IN THE ESTABLISHMENT DECLARATION LABORATORY AND ANSM. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 02NOV20: THE EVENT UNIT IS NOT AVAILABLE TO RETURN FOR EVALUATION. IT HAS BEEN DESTROYED. THE PROCEDURE PERFORMED WAS AN OVARIECTOMY. SCISSORS FROM HAVE BEEN USED DURING THE PROCEDURE. ADDITIONAL INFORM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10818469 ↗
• MalfunctionMay 7, 2018Break; Break

  PROCEDURE PERFORMED: LAP APPENDIX. AT THE END OF THE PROCEDURE, WHILST REMOVING THE SPECIMEN THROUGH THE TROCAR, THE OR STAFF NOTICED THAT PINCH TAB BROKE AND SEAL HOUSING DISLODGED. THE TAB FELL BUT OUTSIDE THE PATIENT. THEY DID NOT USE ANOTHER TROCAR BECAUSE THE PROCEDURE WAS FINISHED ALREADY. PATIENT STATUS: NOT AFFECTED. PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7491264 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  LAP APPENDECTOMY - "DURING THE PROCEDURE A PIECE OF BLACK PLASTIC/RUBBER WAS OBSERVED COMING OUT OF THE PORT INTO THE ABDOMINAL CAVITY. THE FRAGMENT WAS RETRIEVED AND THE TROCAR SWAPPED FOR ANOTHER UNIT. THE REMOVED PORT WAS INSPECTED BY THE SURGEON/SCRUB TEAM AND THE FRAGMENT WAS IDENTIFIED AS PART OF THE INNER SEPTUM. THE CLEAR PLASTIC INSTRUMENT SHIELD WAS REMOVED MANUALLY TO AID INSPECTION. (B)(4). PATIENT STATUS: OK

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372838 ↗
• MalfunctionMar 1, 2017Break; Break

  PROCEDURE PERFORMED UNKNOWN - "THE PORT SNAPPED INTRA OPERATIVELY WHILE IN USE. AT THE TIME A 5MM FORCEP WAS BEING USED THROUGH THIS PORT. THE BOTTOM HALF OF THE PORT WAS WITHIN THE PATIENTS CAVITY AND WAS REMOVED THROUGH ANOTHER PORT SITE." PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6370236 ↗
• MalfunctionJul 11, 2016Detachment Of Device Component; Detachment Of Device Component

  PROCEDURE PERFORMED - UNKNOWN - "RUBBER/PLASTIC CAME OFF WHILE THE TROCAR WAS IN THE PATIENT". ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM (B)(6) AT 8:56 AM ON JULY 6, 2016: I'VE HAD THE FOLLOWING ANSWERS FROM THE SCRUB NURSE THAT WAS PRESENT: 'IT WAS THE RUBBER, 11MM PORT. THE INNER FELL INTO THE PATIENT AND YES IT WAS RETRIEVED.'

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5784423 ↗
• MalfunctionJun 7, 2016Material Fragmentation; Material Fragmentation

  LAP CHOLE - "WHILE PERFORMING LAP CHOLE, THE SURGEON NOTICED, AFTER INSERTING SCISSORS INTO THE TROCAR, SLIVERS OF PLASTIC CONSISTENT WITH THE SAME COLORS OF THE TROCAR CANNULA. THE SLIVERS OF PLASTIC WERE REMOVED DURING THE PROCEDURE. ALSO INCLUDED A NEW PAIR OF SCISSOR INSERTS THAT WERE USED AS WELL AS PICTURES OF THE SLIVERS, SPECIMEN, AND TROCAR USED DURING PROCEDURE." PATIENT STATUS - OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 5704699 ↗